Christopher Dawoud, José Manuel Devesa, Mathias Löhnert, Rosana Vicente, Sherif Akram Metwalli, Stefan Riss
Introduction: The management of faecal incontinence (FI) remains challenging and further treatment modalities are urgently needed. The aim of this study was to assess the efficacy of a novel artificial bowel sphincter (SimplyFI anal band), which is implanted around the anal sphincter complex to enhance continence.
Methods: An exploratory prospective multicentre study based on the IDEAL 2b framework was conducted in patients with FI unresponsive to conservative treatment. Participants underwent SimplyFI implantation, followed by assessments at 1 week and 1, 3, 6, and 12 months after implantation. Intraoperative and postoperative complications were recorded. Functional improvement and quality of life were measured using the St Mark's incontinence score (SMIS) and the Faecal Incontinence Quality of Life Scale (FIQLS).
Results: Eighteen patients were included in the study (17 women, 1 man). The median operating time was 27 (range 13-60) min, with a median hospital stay of 2 (range 1-5) days. One intraoperative complication occurred without affecting the outcome. One patient (5.6%) underwent band removal due to anal discomfort without signs of infection. Relative to baseline, significant improvements were seen at 12 months in median scores for both the SMIS (from 16.5 to 12.5; P = 0.013) and the FIQLS (from 2.0 to 2.6; P = 0.006). Anorectal manometry showed a significant increase in the anal resting pressure from preoperative values to 3 months after implantation (median 15.5 versus 19.0 mmHg, respectively; P = 0.037); however, the increase in anal resting pressure was no longer seen at the 12-month follow-up.
Conclusion: In this exploratory study of 18 patients, the SimplyFI anal band appears to be safe with short-term improvement in function. Future studies with longer follow-up periods are needed to better define the role of this new treatment modality. Registration number: NCT05708612 (http://www.clinicaltrials.gov).
{"title":"Artificial sphincter with a new silicone band for treating faecal incontinence: IDEAL 2b prospective multicentre trial.","authors":"Christopher Dawoud, José Manuel Devesa, Mathias Löhnert, Rosana Vicente, Sherif Akram Metwalli, Stefan Riss","doi":"10.1093/bjsopen/zraf112","DOIUrl":"10.1093/bjsopen/zraf112","url":null,"abstract":"<p><strong>Introduction: </strong>The management of faecal incontinence (FI) remains challenging and further treatment modalities are urgently needed. The aim of this study was to assess the efficacy of a novel artificial bowel sphincter (SimplyFI anal band), which is implanted around the anal sphincter complex to enhance continence.</p><p><strong>Methods: </strong>An exploratory prospective multicentre study based on the IDEAL 2b framework was conducted in patients with FI unresponsive to conservative treatment. Participants underwent SimplyFI implantation, followed by assessments at 1 week and 1, 3, 6, and 12 months after implantation. Intraoperative and postoperative complications were recorded. Functional improvement and quality of life were measured using the St Mark's incontinence score (SMIS) and the Faecal Incontinence Quality of Life Scale (FIQLS).</p><p><strong>Results: </strong>Eighteen patients were included in the study (17 women, 1 man). The median operating time was 27 (range 13-60) min, with a median hospital stay of 2 (range 1-5) days. One intraoperative complication occurred without affecting the outcome. One patient (5.6%) underwent band removal due to anal discomfort without signs of infection. Relative to baseline, significant improvements were seen at 12 months in median scores for both the SMIS (from 16.5 to 12.5; P = 0.013) and the FIQLS (from 2.0 to 2.6; P = 0.006). Anorectal manometry showed a significant increase in the anal resting pressure from preoperative values to 3 months after implantation (median 15.5 versus 19.0 mmHg, respectively; P = 0.037); however, the increase in anal resting pressure was no longer seen at the 12-month follow-up.</p><p><strong>Conclusion: </strong>In this exploratory study of 18 patients, the SimplyFI anal band appears to be safe with short-term improvement in function. Future studies with longer follow-up periods are needed to better define the role of this new treatment modality. Registration number: NCT05708612 (http://www.clinicaltrials.gov).</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12541383/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145343078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joel Johansson, Roland E Andersson, Per Loftås, Stefan Redéen
Background: Appendiceal adenocarcinomas and low-grade appendiceal mucinous neoplasms (LAMNs) are rare tumours. Much of the existing knowledge is derived from registry-based studies, particularly the Surveillance, Epidemiology, and End Results database in the USA.
Methods: This retrospective cohort study used data from the Swedish Cancer Registry, Swedish Cause of Death Registry, and the National Patient Registry to analyse demographic characteristics and outcomes of patients diagnosed with appendiceal adenocarcinoma or LAMN between 2005 and 2019. Kaplan-Meier survivor function, multivariate Cox regression analysis, standardized mortality ratio, and net survival were used to assess survival. Incidence was estimated by direct standardization from 2005 to 2019.
Results: In all, 1159 patients with appendiceal neoplasms were included, with a mean age at diagnosis of 63.3 years. The incidence of adenocarcinomas was stable, whereas the incidence of LAMNs increased from 2012 onwards. Patients with non-mucinous adenocarcinomas who underwent colonic resection had better survival outcomes than patients treated with appendicectomy alone. For mucinous adenocarcinomas, colonic resection did not improve survival outcomes compared with appendicectomy. Patients with non-mucinous adenocarcinoma, mucinous adenocarcinoma, or LAMN who underwent cytoreductive surgery and heated intraperitoneal chemotherapy (CRS-HIPEC) had favourable overall and net survival.
Conclusion: Colonic resection increased survival only for patients with non-mucinous adenocarcinomas. Since 2012, the incidence of LAMN has increased, most likely due to changes in diagnostic and coding practices, but the incidence of appendiceal adenocarcinomas has remained stable. The survival benefit of CRS-HIPEC is observed in a very specific patient population, emphasizing the importance of careful patient selection.
{"title":"Incidence, treatment, and survival of patients with appendiceal adenocarcinomas and low-grade appendiceal mucinous neoplasms: linked Swedish national registry study.","authors":"Joel Johansson, Roland E Andersson, Per Loftås, Stefan Redéen","doi":"10.1093/bjsopen/zraf109","DOIUrl":"10.1093/bjsopen/zraf109","url":null,"abstract":"<p><strong>Background: </strong>Appendiceal adenocarcinomas and low-grade appendiceal mucinous neoplasms (LAMNs) are rare tumours. Much of the existing knowledge is derived from registry-based studies, particularly the Surveillance, Epidemiology, and End Results database in the USA.</p><p><strong>Methods: </strong>This retrospective cohort study used data from the Swedish Cancer Registry, Swedish Cause of Death Registry, and the National Patient Registry to analyse demographic characteristics and outcomes of patients diagnosed with appendiceal adenocarcinoma or LAMN between 2005 and 2019. Kaplan-Meier survivor function, multivariate Cox regression analysis, standardized mortality ratio, and net survival were used to assess survival. Incidence was estimated by direct standardization from 2005 to 2019.</p><p><strong>Results: </strong>In all, 1159 patients with appendiceal neoplasms were included, with a mean age at diagnosis of 63.3 years. The incidence of adenocarcinomas was stable, whereas the incidence of LAMNs increased from 2012 onwards. Patients with non-mucinous adenocarcinomas who underwent colonic resection had better survival outcomes than patients treated with appendicectomy alone. For mucinous adenocarcinomas, colonic resection did not improve survival outcomes compared with appendicectomy. Patients with non-mucinous adenocarcinoma, mucinous adenocarcinoma, or LAMN who underwent cytoreductive surgery and heated intraperitoneal chemotherapy (CRS-HIPEC) had favourable overall and net survival.</p><p><strong>Conclusion: </strong>Colonic resection increased survival only for patients with non-mucinous adenocarcinomas. Since 2012, the incidence of LAMN has increased, most likely due to changes in diagnostic and coding practices, but the incidence of appendiceal adenocarcinomas has remained stable. The survival benefit of CRS-HIPEC is observed in a very specific patient population, emphasizing the importance of careful patient selection.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12419524/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145028944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Surgical decision-making for breast cancer requires consideration of both treatment outcomes and health-related quality of life (HR-QoL). However, data on HR-QoL differences across surgical procedures remain limited. This study compared breast satisfaction and HR-QoL among Japanese patients with breast cancer undergoing mastectomy (MT), breast-conserving surgery (BCS), or immediate breast reconstruction (IBR).
Methods: A survey using the Japanese version of the BREAST-Q was conducted among patients with primary breast cancer who underwent surgery between August 2013 and July 2021.
Results: Of 648 patients, 577 were included in this study. The median time from surgery to questionnaire completion was 56 months. Satisfaction with breast scores was highest in patients undergoing BCS, followed by those undergoing IBR and MT. Psychosocial and sexual well-being were significantly better in patients undergoing BCS and IBR than in those undergoing MT, whereas physical well-being showed no significant differences among the three groups. In multiple regression analysis, surgical procedure was identified as the most influential factor for breast satisfaction, psychosocial well-being, and sexual well-being.
Conclusions: This multicentre Japanese study confirmed that the choice of surgical procedure is the most influential factor affecting postoperative HR-QoL, with both BCS and IBR offering advantages over MT. The findings highlight the importance of comprehensive preoperative counselling to ensure patients receive detailed information on potential HR-QoL differences.
{"title":"Breast satisfaction and health-related quality of life following total mastectomy, breast-conserving surgery, or immediate breast reconstruction in Japanese patients with breast cancer: multicentre cross-sectional controlled study (Reborn).","authors":"Hirohito Seki, Takako Komiya, Yoshihiro Sowa, Maho Kato, Yutaka Nishida, Hirotsugu Isaka, Jyunji Takano, Shigeru Imoto, Miho Saiga","doi":"10.1093/bjsopen/zraf094","DOIUrl":"10.1093/bjsopen/zraf094","url":null,"abstract":"<p><strong>Background: </strong>Surgical decision-making for breast cancer requires consideration of both treatment outcomes and health-related quality of life (HR-QoL). However, data on HR-QoL differences across surgical procedures remain limited. This study compared breast satisfaction and HR-QoL among Japanese patients with breast cancer undergoing mastectomy (MT), breast-conserving surgery (BCS), or immediate breast reconstruction (IBR).</p><p><strong>Methods: </strong>A survey using the Japanese version of the BREAST-Q was conducted among patients with primary breast cancer who underwent surgery between August 2013 and July 2021.</p><p><strong>Results: </strong>Of 648 patients, 577 were included in this study. The median time from surgery to questionnaire completion was 56 months. Satisfaction with breast scores was highest in patients undergoing BCS, followed by those undergoing IBR and MT. Psychosocial and sexual well-being were significantly better in patients undergoing BCS and IBR than in those undergoing MT, whereas physical well-being showed no significant differences among the three groups. In multiple regression analysis, surgical procedure was identified as the most influential factor for breast satisfaction, psychosocial well-being, and sexual well-being.</p><p><strong>Conclusions: </strong>This multicentre Japanese study confirmed that the choice of surgical procedure is the most influential factor affecting postoperative HR-QoL, with both BCS and IBR offering advantages over MT. The findings highlight the importance of comprehensive preoperative counselling to ensure patients receive detailed information on potential HR-QoL differences.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12461568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xi Wang, Xiubi Yin, Shaohua Song, Di Jiang, Yuancheng Li, Zeliang Xu, Xingchao Liu, Zhu Li, Xiaofang Zhang, Chengcheng Zhang
Background: Improvements in medical standards have allowed critically ill patients to benefit from liver transplantation, but defining futility arbitrarily according to one single-stage outcome could deprive patients of the potential benefits of transplantation. This study aimed to redefine futile liver transplantation by multiterm outcomes and develop a novel scoring system to predict futile liver transplantation.
Methods: This retrospective study in China enrolled patients who had liver transplantation from 3 centres between January 2015 and April 2021. Independent risk factors were identified by logistic regression analysis and used to establish risk prediction models. Kaplan-Meier survival curves were calculated to explore the association between futile score and overall survival.
Results: Of 1408 patients undergoing liver transplantation, patients at persistent high risk for mortality in the short term (3 months), mid term (1 year), and long term (3 years) were defined as the truly futile liver transplantation group. Higher donor and recipient age, hepatorenal syndrome, intensive care unit stay, need for mechanical ventilator, ABO blood group incompatibility, prolonged cold ischaemia time, increased alanine aminotransferase levels, and decreased albumin levels were independent risk factors for futility, and were used to construct a futile scoring system. The scoring system had good predictive capability, with an area under the receiver operating characteristic curve of 0.921, better than that of a previously established scoring system. Survival analysis showed that the group with a high futile risk had decreased survival.
Conclusion: This study has redefined futile liver transplantation and established a novel futile scoring system. This can be used to optimize the allocation of medical resources, especially with regard to recipient selection for liver transplantation, and increase survival prediction for selected patients.
{"title":"Novel scoring system to predict futile liver transplantation by multiterm outcomes to optimize recipient selection: retrospective cohort study.","authors":"Xi Wang, Xiubi Yin, Shaohua Song, Di Jiang, Yuancheng Li, Zeliang Xu, Xingchao Liu, Zhu Li, Xiaofang Zhang, Chengcheng Zhang","doi":"10.1093/bjsopen/zraf108","DOIUrl":"10.1093/bjsopen/zraf108","url":null,"abstract":"<p><strong>Background: </strong>Improvements in medical standards have allowed critically ill patients to benefit from liver transplantation, but defining futility arbitrarily according to one single-stage outcome could deprive patients of the potential benefits of transplantation. This study aimed to redefine futile liver transplantation by multiterm outcomes and develop a novel scoring system to predict futile liver transplantation.</p><p><strong>Methods: </strong>This retrospective study in China enrolled patients who had liver transplantation from 3 centres between January 2015 and April 2021. Independent risk factors were identified by logistic regression analysis and used to establish risk prediction models. Kaplan-Meier survival curves were calculated to explore the association between futile score and overall survival.</p><p><strong>Results: </strong>Of 1408 patients undergoing liver transplantation, patients at persistent high risk for mortality in the short term (3 months), mid term (1 year), and long term (3 years) were defined as the truly futile liver transplantation group. Higher donor and recipient age, hepatorenal syndrome, intensive care unit stay, need for mechanical ventilator, ABO blood group incompatibility, prolonged cold ischaemia time, increased alanine aminotransferase levels, and decreased albumin levels were independent risk factors for futility, and were used to construct a futile scoring system. The scoring system had good predictive capability, with an area under the receiver operating characteristic curve of 0.921, better than that of a previously established scoring system. Survival analysis showed that the group with a high futile risk had decreased survival.</p><p><strong>Conclusion: </strong>This study has redefined futile liver transplantation and established a novel futile scoring system. This can be used to optimize the allocation of medical resources, especially with regard to recipient selection for liver transplantation, and increase survival prediction for selected patients.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12527355/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145298246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Unexpected horizontal tumour spread towards the proximal and distal margins complicates the assessment of surgical margins in oesophagogastric junction (OGJ) cancer. Its impact on oncological outcomes remains unclear.
Methods: This study retrospectively analysed patients with OGJ adenocarcinoma undergoing proximal or total gastrectomy. Unexpected horizontal tumour spread was measured as the discrepancy between gross and pathological margins proximally (ΔPM) and distally (ΔDM). Clinicopathological features, recurrence-free survival (RFS), and overall survival (OS) were evaluated based on ΔPM and ΔDM.
Results: Based on cut-off values identified by time-dependent receiver operating characteristic curve analysis (ΔPM, 8 mm; ΔDM, 3 mm) in 197 patients, patients were classified into four groups: short; long ΔPM; long ΔDM; and both long ΔPM and ΔDM (both-long). RFS was best in the short group and worst in the both-long group. The long ΔPM and long ΔDM groups had intermediate and comparable RFS. Subsequently, patients were categorized into two groups: a short group and a long group, which included patients in the long ΔPM, long ΔDM, and both-long groups. The type of infiltrative growth and postoperative recurrence were significantly associated with the long group. Moreover, the long group had significantly worse RFS and OS than the short group. Multivariate Cox regression analyses identified the long group as an independent risk factor for both RFS and OS. Patients in the long group with clinical lymph node metastasis or tumours located in the proximal 2-cm segment of the OGJ, predominantly in the proximal rather than distal 2-cm segment of the OGJ, or equal involvement in both areas had markedly worse survival outcomes.
Conclusion: Unexpected horizontal tumour spread, represented by ΔPM and ΔDM, is a strong predictor of poor survival and recurrence in OGJ cancer. Intraoperative assessment of ΔPM and ΔDM using frozen section analysis may be useful in guiding additional resections, particularly when combined with other predictive factors.
{"title":"Oncological impact of unexpected horizontal tumour spread in oesophagogastric junction cancer.","authors":"Qingjiang Hu, Manabu Ohashi, Motonari Ri, Rie Makuuchi, Tomoyuki Irino, Masaru Hayami, Takeshi Sano, Souya Nunobe","doi":"10.1093/bjsopen/zraf119","DOIUrl":"10.1093/bjsopen/zraf119","url":null,"abstract":"<p><strong>Background: </strong>Unexpected horizontal tumour spread towards the proximal and distal margins complicates the assessment of surgical margins in oesophagogastric junction (OGJ) cancer. Its impact on oncological outcomes remains unclear.</p><p><strong>Methods: </strong>This study retrospectively analysed patients with OGJ adenocarcinoma undergoing proximal or total gastrectomy. Unexpected horizontal tumour spread was measured as the discrepancy between gross and pathological margins proximally (ΔPM) and distally (ΔDM). Clinicopathological features, recurrence-free survival (RFS), and overall survival (OS) were evaluated based on ΔPM and ΔDM.</p><p><strong>Results: </strong>Based on cut-off values identified by time-dependent receiver operating characteristic curve analysis (ΔPM, 8 mm; ΔDM, 3 mm) in 197 patients, patients were classified into four groups: short; long ΔPM; long ΔDM; and both long ΔPM and ΔDM (both-long). RFS was best in the short group and worst in the both-long group. The long ΔPM and long ΔDM groups had intermediate and comparable RFS. Subsequently, patients were categorized into two groups: a short group and a long group, which included patients in the long ΔPM, long ΔDM, and both-long groups. The type of infiltrative growth and postoperative recurrence were significantly associated with the long group. Moreover, the long group had significantly worse RFS and OS than the short group. Multivariate Cox regression analyses identified the long group as an independent risk factor for both RFS and OS. Patients in the long group with clinical lymph node metastasis or tumours located in the proximal 2-cm segment of the OGJ, predominantly in the proximal rather than distal 2-cm segment of the OGJ, or equal involvement in both areas had markedly worse survival outcomes.</p><p><strong>Conclusion: </strong>Unexpected horizontal tumour spread, represented by ΔPM and ΔDM, is a strong predictor of poor survival and recurrence in OGJ cancer. Intraoperative assessment of ΔPM and ΔDM using frozen section analysis may be useful in guiding additional resections, particularly when combined with other predictive factors.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12502906/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tycho B Moojen, Malaika S Vlug, Eva Visser, Maud A Reijntjes, Johan F M Lange, Gabriele Bislenghi, Michele Carvello, Janindra Warusavitarne, Roel Hompes, Laurents P S Stassen, Omar D Faiz, Antonino Spinelli, André D'Hoore, Willem A Bemelman
Background: Chronic anastomotic leakage (AL) is the most common cause of pouch failure after restorative proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis. This study investigated factors associated with AL and successful salvage of leaking anastomoses after ileoanal pouch surgery.
Method: This multicentre retrospective cohort study included patients aged ≥ 18 years with ulcerative colitis or unclassified inflammatory bowel disease who underwent ileoanal pouch surgery between 2016 and 2021 in six European centres, with a > 12-month follow-up. The primary outcome was AL rate. Secondary outcomes included factors associated with AL occurrence, timing of AL diagnosis (early (< 21 days) versus late), AL management, AL salvage rate, and stoma-free survival.
Results: Overall, 411 patients were included, of whom 13.6% (56) had a diagnosed AL. The rate of AL was significantly higher in low-volume (less than ten procedures annually) centres (28.0% versus 12.7%; P = 0.031). Of the 56 ALs, 44 were diagnosed as early leaks and 12 were diagnosed as late leaks. A three-stage approach was associated with late diagnosis and treatment. AL was managed using various techniques, including diverting ileostomy, antibiotics, and drainage. The overall AL salvage rate was 85.4%, but increased to 92% when diagnosed and treated early (compared with 60% when diagnosed and treated late; P = 0.010). Successful AL salvage was associated with long-term stoma-free status (P = 0.002). The median follow-up was 3.8 years (range 1.0-8.1 years). The long-term stoma-free rate was 95.5% in patients with AL diagnosed and treated early, but only 41.7% when diagnosed and treated late (P < 0.001).
Conclusion: Early diagnosis and treatment of AL diminishes the negative effect of AL after ileoanal pouch surgery. Proactive anastomotic assessment enable early diagnosis and management, especially in patients undergoing a three-stage approach.
{"title":"Anastomotic leakage after ileoanal pouch surgery: risk factors and salvage rate.","authors":"Tycho B Moojen, Malaika S Vlug, Eva Visser, Maud A Reijntjes, Johan F M Lange, Gabriele Bislenghi, Michele Carvello, Janindra Warusavitarne, Roel Hompes, Laurents P S Stassen, Omar D Faiz, Antonino Spinelli, André D'Hoore, Willem A Bemelman","doi":"10.1093/bjsopen/zraf110","DOIUrl":"10.1093/bjsopen/zraf110","url":null,"abstract":"<p><strong>Background: </strong>Chronic anastomotic leakage (AL) is the most common cause of pouch failure after restorative proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis. This study investigated factors associated with AL and successful salvage of leaking anastomoses after ileoanal pouch surgery.</p><p><strong>Method: </strong>This multicentre retrospective cohort study included patients aged ≥ 18 years with ulcerative colitis or unclassified inflammatory bowel disease who underwent ileoanal pouch surgery between 2016 and 2021 in six European centres, with a > 12-month follow-up. The primary outcome was AL rate. Secondary outcomes included factors associated with AL occurrence, timing of AL diagnosis (early (< 21 days) versus late), AL management, AL salvage rate, and stoma-free survival.</p><p><strong>Results: </strong>Overall, 411 patients were included, of whom 13.6% (56) had a diagnosed AL. The rate of AL was significantly higher in low-volume (less than ten procedures annually) centres (28.0% versus 12.7%; P = 0.031). Of the 56 ALs, 44 were diagnosed as early leaks and 12 were diagnosed as late leaks. A three-stage approach was associated with late diagnosis and treatment. AL was managed using various techniques, including diverting ileostomy, antibiotics, and drainage. The overall AL salvage rate was 85.4%, but increased to 92% when diagnosed and treated early (compared with 60% when diagnosed and treated late; P = 0.010). Successful AL salvage was associated with long-term stoma-free status (P = 0.002). The median follow-up was 3.8 years (range 1.0-8.1 years). The long-term stoma-free rate was 95.5% in patients with AL diagnosed and treated early, but only 41.7% when diagnosed and treated late (P < 0.001).</p><p><strong>Conclusion: </strong>Early diagnosis and treatment of AL diminishes the negative effect of AL after ileoanal pouch surgery. Proactive anastomotic assessment enable early diagnosis and management, especially in patients undergoing a three-stage approach.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12461575/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maziar Nikberg, Viktor Åkerlund, Torbjörn Swartling, Pamela Buchwald, Kenneth Smedh
Background: In patients with rectal cancer, when it is not possible to restore bowel continuity with an anastomosis, the optimal surgical method is still a matter of debate. The aim of this trial was to determine 30-day postoperative surgical complication rates after Hartmann's procedure (HP) versus intersphincteric abdominoperineal excision (iAPE) in patients with rectal cancer who were not suitable for restorative surgery.
Methods: This multicentre randomized controlled trial (HAPIrect) was performed in Sweden and Finland between 2014 and 2021. Eligible patients with adenocarcinoma of the rectum located ≥ 5 cm from the anal verge and deemed unsuitable for anterior resection with anastomosis were randomized (1:1) intraoperatively to either HP or iAPE. The primary outcome was 30-day postoperative surgical complications. Secondary outcomes were major surgical complications (Clavien-Dindo grade ≥ IIIa), perineopelvic complications, and overall complications. Logistic regression in the intention-to-treat population was the primary method used to compare the surgical approaches.
Results: Of 194 eligible patients, 163 were randomized (80 patients to HP and 83 to iAPE). The study was closed before achieving the target accrual. The main reasons for not receiving an anastomosis were advanced age, co-morbidity, or poor anal sphincter function. Mean operating time in the HP and iAPE groups was 291 and 373 minutes, respectively. In the HP and iAPE groups, the surgical complication rate was 39% and 43%, respectively (odds ratio (OR) for HP 0.83; 95% confidence interval (c.i.) 0.44 to 1.54; P = 0.549) and the rate of major surgical complications was 14% and 11%, respectively (P = 0.573). Perineopelvic complications occurred in 21% and 30% of patients in the HP and iAPE groups, respectively (OR for HP 0.63; 95% c.i. 0.31 to 1.28; P = 0.197). The overall complication rate (including both medical and surgical complications) was 45% and 49% in the HP and iAPE groups, respectively (P = 0.574). In multivariable analysis adjusted for sex, preoperative radiotherapy, and surgical procedure, there was no statistically significant difference in surgical complications between the two groups.
Conclusion: Although the trial was underpowered and did not reach accrual, in randomized patients, both HP and iAPE are practicable surgical options for patients unsuitable for anastomosis.
背景:在直肠癌患者中,当无法通过吻合恢复肠的连续性时,最佳的手术方法仍然是一个有争议的问题。本试验的目的是确定在不适合恢复性手术的直肠癌患者中,Hartmann手术(HP)和括约肌间腹会阴切除术(iAPE)后30天的手术并发症发生率。方法:这项多中心随机对照试验(HAPIrect)于2014年至2021年在瑞典和芬兰进行。符合条件的直肠腺癌患者位于距肛门边缘≥5cm,认为不适合前切吻合术,术中随机(1:1)选择HP或iAPE。主要结局是术后30天的手术并发症。次要结局为主要手术并发症(Clavien-Dindo分级≥IIIa)、盆腔周围并发症和总并发症。意向治疗人群的逻辑回归是比较手术入路的主要方法。结果:194例符合条件的患者中,163例随机化(80例HP组,83例iAPE组)。该研究在达到目标收益之前就结束了。不接受吻合术的主要原因是高龄、合并症或肛门括约肌功能差。HP组和iAPE组的平均手术时间分别为291分钟和373分钟。HP组和iAPE组手术并发症发生率分别为39%和43% (HP组的优势比(OR)为0.83;95%置信区间(ci .)0.44 ~ 1.54;P = 0.549),主要手术并发症发生率分别为14%和11% (P = 0.573)。HP组和iAPE组患者盆腔周围并发症发生率分别为21%和30% (HP OR 0.63; 95% ci 0.31 ~ 1.28; P = 0.197)。HP组和iAPE组的总并发症发生率(包括内科和外科并发症)分别为45%和49% (P = 0.574)。在校正性别、术前放疗和手术方式的多变量分析中,两组手术并发症无统计学差异。结论:虽然该试验功率不足且未达到累积效果,但在随机患者中,HP和iAPE对于不适合吻合的患者都是可行的手术选择。注册号:NCT01995396 (http://www.clinicaltrials.gov)。
{"title":"Postoperative complications in Hartmann's procedure versus intersphincteric abdominoperineal excision in rectal cancer: randomized clinical trial (HAPIrect).","authors":"Maziar Nikberg, Viktor Åkerlund, Torbjörn Swartling, Pamela Buchwald, Kenneth Smedh","doi":"10.1093/bjsopen/zraf093","DOIUrl":"10.1093/bjsopen/zraf093","url":null,"abstract":"<p><strong>Background: </strong>In patients with rectal cancer, when it is not possible to restore bowel continuity with an anastomosis, the optimal surgical method is still a matter of debate. The aim of this trial was to determine 30-day postoperative surgical complication rates after Hartmann's procedure (HP) versus intersphincteric abdominoperineal excision (iAPE) in patients with rectal cancer who were not suitable for restorative surgery.</p><p><strong>Methods: </strong>This multicentre randomized controlled trial (HAPIrect) was performed in Sweden and Finland between 2014 and 2021. Eligible patients with adenocarcinoma of the rectum located ≥ 5 cm from the anal verge and deemed unsuitable for anterior resection with anastomosis were randomized (1:1) intraoperatively to either HP or iAPE. The primary outcome was 30-day postoperative surgical complications. Secondary outcomes were major surgical complications (Clavien-Dindo grade ≥ IIIa), perineopelvic complications, and overall complications. Logistic regression in the intention-to-treat population was the primary method used to compare the surgical approaches.</p><p><strong>Results: </strong>Of 194 eligible patients, 163 were randomized (80 patients to HP and 83 to iAPE). The study was closed before achieving the target accrual. The main reasons for not receiving an anastomosis were advanced age, co-morbidity, or poor anal sphincter function. Mean operating time in the HP and iAPE groups was 291 and 373 minutes, respectively. In the HP and iAPE groups, the surgical complication rate was 39% and 43%, respectively (odds ratio (OR) for HP 0.83; 95% confidence interval (c.i.) 0.44 to 1.54; P = 0.549) and the rate of major surgical complications was 14% and 11%, respectively (P = 0.573). Perineopelvic complications occurred in 21% and 30% of patients in the HP and iAPE groups, respectively (OR for HP 0.63; 95% c.i. 0.31 to 1.28; P = 0.197). The overall complication rate (including both medical and surgical complications) was 45% and 49% in the HP and iAPE groups, respectively (P = 0.574). In multivariable analysis adjusted for sex, preoperative radiotherapy, and surgical procedure, there was no statistically significant difference in surgical complications between the two groups.</p><p><strong>Conclusion: </strong>Although the trial was underpowered and did not reach accrual, in randomized patients, both HP and iAPE are practicable surgical options for patients unsuitable for anastomosis.</p><p><strong>Registration number: </strong>NCT01995396 (http://www.clinicaltrials.gov).</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482908/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198050","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Suvi Rasilainen, Mohamud Aden, Antti J Kivelä, Sakari Pakarinen, Jukka Rintala, Susanna Niemeläinen, Ilona Helavirta, Salla Moilanen, Anne Mattila, Tarja Pinta, Kapo Saukkonen, Pälvi Vento, Niko Turkka, Pasi Pengermä, Jenny Häggblom, Tom Scheinin
Background: This study evaluated the outcomes of colonic volvulus management in a national cohort, and identified risk factors for morbidity and mortality.
Methods: This was a multicentre national retrospective study of patients presenting with colonic volvulus between 2010 and 2019. Main outcome measures were 30-day and 1-year mortality. Multivariable regression and Kaplan-Meier analyses were used to study predictors of mortality and survival.
Results: Of the 559 patients presenting with sigmoid volvulus, 381 underwent surgery and 178 received conservative treatment. The 30-day mortality rates were 11.0% and 19.0%, respectively. Emergency surgery (P = 0.030), nursing home residence (P = 0.040), increased co-morbidity (P = 0.017), and male sex (P = 0.029) predicted postoperative 30-day mortality. Primary endoscopic detorsion followed by elective surgery during a subsequent hospital admission resulted in best survival. Of the 342 patients presenting with caecal volvulus, 340 underwent surgery. The 30-day mortality rate was 6.4%. Increased co-morbidity (P = 0.008), nursing home residence (P = 0.002), and necrotic caecum (P = 0.007) predicted 30-day mortality. At 1 year, the mortality rate among patients with sigmoid volvulus was 19.9% after surgery and 43.2% after conservative treatment. Emergency surgery (P = 0.023), nursing home residence (P = 0.009), and increased co-morbidity (P < 0.001) were associated with 1-year postoperative mortality. In patients with caecal volvulus the 1-year mortality rate was 13.1%. Increased co-morbidity (P < 0.001) and nursing home residence (P < 0.001) were predictive. Anastomotic leakage in patients with sigmoid volvulus was associated with an American Society of Anesthesiologists fitness grade of III (P = 0.032) and total colectomy (P = 0.012).
Conclusion: Surgery should be recommended for colonic volvulus where co-morbidity, patient preference, and functional status allows. Surgically unfit patients have poorer outcomes. Elective sigmoidectomy after endoscopic detorsion is preferred as it carries the lowest mortality risk. Necrotic bowel, dependency, and co-morbidities predict death for both sigmoid and caecal volvulus.
{"title":"Management and risk factors for colonic volvulus: retrospective national cohort study.","authors":"Suvi Rasilainen, Mohamud Aden, Antti J Kivelä, Sakari Pakarinen, Jukka Rintala, Susanna Niemeläinen, Ilona Helavirta, Salla Moilanen, Anne Mattila, Tarja Pinta, Kapo Saukkonen, Pälvi Vento, Niko Turkka, Pasi Pengermä, Jenny Häggblom, Tom Scheinin","doi":"10.1093/bjsopen/zraf113","DOIUrl":"10.1093/bjsopen/zraf113","url":null,"abstract":"<p><strong>Background: </strong>This study evaluated the outcomes of colonic volvulus management in a national cohort, and identified risk factors for morbidity and mortality.</p><p><strong>Methods: </strong>This was a multicentre national retrospective study of patients presenting with colonic volvulus between 2010 and 2019. Main outcome measures were 30-day and 1-year mortality. Multivariable regression and Kaplan-Meier analyses were used to study predictors of mortality and survival.</p><p><strong>Results: </strong>Of the 559 patients presenting with sigmoid volvulus, 381 underwent surgery and 178 received conservative treatment. The 30-day mortality rates were 11.0% and 19.0%, respectively. Emergency surgery (P = 0.030), nursing home residence (P = 0.040), increased co-morbidity (P = 0.017), and male sex (P = 0.029) predicted postoperative 30-day mortality. Primary endoscopic detorsion followed by elective surgery during a subsequent hospital admission resulted in best survival. Of the 342 patients presenting with caecal volvulus, 340 underwent surgery. The 30-day mortality rate was 6.4%. Increased co-morbidity (P = 0.008), nursing home residence (P = 0.002), and necrotic caecum (P = 0.007) predicted 30-day mortality. At 1 year, the mortality rate among patients with sigmoid volvulus was 19.9% after surgery and 43.2% after conservative treatment. Emergency surgery (P = 0.023), nursing home residence (P = 0.009), and increased co-morbidity (P < 0.001) were associated with 1-year postoperative mortality. In patients with caecal volvulus the 1-year mortality rate was 13.1%. Increased co-morbidity (P < 0.001) and nursing home residence (P < 0.001) were predictive. Anastomotic leakage in patients with sigmoid volvulus was associated with an American Society of Anesthesiologists fitness grade of III (P = 0.032) and total colectomy (P = 0.012).</p><p><strong>Conclusion: </strong>Surgery should be recommended for colonic volvulus where co-morbidity, patient preference, and functional status allows. Surgically unfit patients have poorer outcomes. Elective sigmoidectomy after endoscopic detorsion is preferred as it carries the lowest mortality risk. Necrotic bowel, dependency, and co-morbidities predict death for both sigmoid and caecal volvulus.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12461565/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136264","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Adam D Gerrard, Roberta Garau, Yasuko Maeda, Alastair Thomson, Evropi Theodoratou, Malcolm G Dunlop, Farhat V N Din
Background: Colorectal cancer (CRC) screening programmes aim to detect early, asymptomatic cancers and improve survival. This study aimed to establish the proportion of interval cancers, and the consequences with regard to stage, clinical outcome, and overall survival. Risk factors associated with interval CRCs were investigated.
Methods: The Scottish Bowel Screening Programme uses faecal immunochemical testing at a threshold of 80 µg haemoglobin per g as a positive trigger for investigation. Screening was offered to all eligible individuals in one region, from November 2017 to October 2021. Cancer registries were cross-checked to ensure complete capture of all cancers including interval CRCs. The primary outcome was rate of interval CRCs among participants with follow-up of 24 months, and its relationship to faecal immunochemical testing results, clinical variables, stage, time to diagnosis, and survival. The secondary outcome was identification of risk factors associated with interval CRCs.
Results: The Scottish Bowel Screening Programme generated 316 583 tests during the study period. Participation was 71.0% of the eligible population (212 664 patients); it was greater among women (71.9 versus 70.0%; P < 0.001) and in higher socioeconomic areas (76.9 versus 58.6%; P < 0.001). In the screened population, 546 CRCs were diagnosed within 2 years of screening. Some 289 of these patients (52.9%) had positive bowel screening. There were 257 patients with interval CRCs, who waited a median of 13 (interquartile range 7-20) months for diagnosis. Of CRCs diagnosed, 24.9% had screening faecal immunochemical test results of < 10 µg haemoglobin per g. The interval CRC rate was greater in women, older patients, and among the least socioeconomically deprived. Interval CRCs were associated with worse 2-year all-cause mortality than screen-detected CRCs (23.0 versus 10.8%; P < 0.001). Importantly, 121 of the 257 interval CRCs (47.1%) had detectable faecal immunochemical test results at 10-79 µg haemoglobin per g.
Conclusion: Patients with interval CRCs and a detectable faecal immunochemical test result below the predetermined threshold appear to be significantly disadvantaged with respect to stage at presentation and survival. Almost half of interval CRCs diagnosed within 2 years had detectable haemoglobin on screening faecal immunochemical test and would be a target for lower positivity thresholds.
背景:结直肠癌(CRC)筛查计划旨在发现早期、无症状的癌症并提高生存率。本研究旨在确定间隔期癌症的比例,以及与分期、临床结局和总生存期有关的结果。研究了与间歇期crc相关的危险因素。方法:苏格兰肠道筛查计划使用粪便免疫化学测试,阈值为80µg血红蛋白/ g作为调查的阳性触发因素。从2017年11月到2021年10月,对一个地区的所有符合条件的个人进行了筛查。癌症登记处进行了交叉检查,以确保完全捕获包括间隔crc在内的所有癌症。主要结局是随访24个月的参与者间期crc的发生率,以及其与粪便免疫化学检测结果、临床变量、分期、诊断时间和生存率的关系。次要结局是确定与间歇期crc相关的危险因素。结果:苏格兰肠道筛查计划在研究期间进行了316583次测试。符合条件的人群中有71.0%(212 664例患者)参与了研究;女性(71.9%对70.0%,P < 0.001)和社会经济地位较高的地区(76.9对58.6%,P < 0.001)患病率更高。在接受筛查的人群中,546例在筛查后2年内被诊断出crc。其中289例(52.9%)患者的肠道筛查呈阳性。257例间歇期crc患者等待诊断的中位时间为13个月(四分位数间距7-20个月)。在诊断的CRC中,24.9%的筛查粪便免疫化学测试结果< 10µg血红蛋白/ g。间隔期CRC率在女性、老年患者和社会经济条件最低的患者中更高。间隔期crc的2年全因死亡率比筛查检测的crc更差(23.0% vs 10.8%; P < 0.001)。重要的是,257例间断性crc中有121例(47.1%)的粪便免疫化学检测结果为每g 10-79µg血红蛋白。结论:间断性crc患者的粪便免疫化学检测结果低于预定阈值,在发病和生存方面明显处于不利地位。在2年内诊断出的间隔期crc中,几乎有一半在筛查粪便免疫化学试验中可检测到血红蛋白,这将是较低阳性阈值的目标。
{"title":"Risk factors and clinical consequences of interval cancers arising within faecal immunochemical testing-based colorectal cancer screening programme.","authors":"Adam D Gerrard, Roberta Garau, Yasuko Maeda, Alastair Thomson, Evropi Theodoratou, Malcolm G Dunlop, Farhat V N Din","doi":"10.1093/bjsopen/zraf096","DOIUrl":"10.1093/bjsopen/zraf096","url":null,"abstract":"<p><strong>Background: </strong>Colorectal cancer (CRC) screening programmes aim to detect early, asymptomatic cancers and improve survival. This study aimed to establish the proportion of interval cancers, and the consequences with regard to stage, clinical outcome, and overall survival. Risk factors associated with interval CRCs were investigated.</p><p><strong>Methods: </strong>The Scottish Bowel Screening Programme uses faecal immunochemical testing at a threshold of 80 µg haemoglobin per g as a positive trigger for investigation. Screening was offered to all eligible individuals in one region, from November 2017 to October 2021. Cancer registries were cross-checked to ensure complete capture of all cancers including interval CRCs. The primary outcome was rate of interval CRCs among participants with follow-up of 24 months, and its relationship to faecal immunochemical testing results, clinical variables, stage, time to diagnosis, and survival. The secondary outcome was identification of risk factors associated with interval CRCs.</p><p><strong>Results: </strong>The Scottish Bowel Screening Programme generated 316 583 tests during the study period. Participation was 71.0% of the eligible population (212 664 patients); it was greater among women (71.9 versus 70.0%; P < 0.001) and in higher socioeconomic areas (76.9 versus 58.6%; P < 0.001). In the screened population, 546 CRCs were diagnosed within 2 years of screening. Some 289 of these patients (52.9%) had positive bowel screening. There were 257 patients with interval CRCs, who waited a median of 13 (interquartile range 7-20) months for diagnosis. Of CRCs diagnosed, 24.9% had screening faecal immunochemical test results of < 10 µg haemoglobin per g. The interval CRC rate was greater in women, older patients, and among the least socioeconomically deprived. Interval CRCs were associated with worse 2-year all-cause mortality than screen-detected CRCs (23.0 versus 10.8%; P < 0.001). Importantly, 121 of the 257 interval CRCs (47.1%) had detectable faecal immunochemical test results at 10-79 µg haemoglobin per g.</p><p><strong>Conclusion: </strong>Patients with interval CRCs and a detectable faecal immunochemical test result below the predetermined threshold appear to be significantly disadvantaged with respect to stage at presentation and survival. Almost half of interval CRCs diagnosed within 2 years had detectable haemoglobin on screening faecal immunochemical test and would be a target for lower positivity thresholds.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12507088/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145249509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chu Luan Nguyen, Jianing Kwok, Michael Zhou, Neshanth Easwaralingam, Jue Li Seah, Belinda Chan, Susannah Graham, Farhad Azimi, Cindy Mak, Carlo Pulitano, Sanjay Warrier
Background: Standard sentinel lymph node (SLN) mapping for early breast cancer involves technetium-99m (99mTc) lymphoscintigraphy. Indocyanine green (ICG) fluorescence allows real-time visualization of lymphatics and nodes while avoiding radiation exposure and the inconvenience of 99mTc, but its inclusion in international guidelines is not widespread. This study compared efficacy and costs between ICG and 99mTc for axillary SLN lymphatic mapping.
Methods: Patients with early breast cancer and clinically negative axilla who underwent lymphatic mapping with ICG and 99mTc were enrolled in a prospective single-institution single-arm non-randomized trial (2021-2024). Data on the number of SLNs, including metastatic nodes, rate of failed mapping, costs, and the surgeon's reported ease of mapping with ICG compared with 99mTc were collected. Cost analysis used Medicare item numbers and microcosting.
Results: A total of 305 patients were enrolled, with 637 SLNs sampled. The SLN identification rate was 97.8% (95% confidence interval (c.i.) 96.3 to 98.7%) for ICG and 98.3% (95% c.i. 96.9 to 99%) for 99mTc. The mean(standard deviation (s.d.)) number of SLNs identified with ICG and 99mTc was 2.06 (1.99) and 2.07 (2.02), respectively (P = 0.871). Metastatic SLNs were identified in 70 of 305 patients (23.0%), with 83 metastatic SLNs in total. ICG identified 79 of 83 metastatic SLNs (95.2%; 95% c.i. 88.3 to 98.1%) and 99mTc identified 82 of 83 metastatic SLNs (98.8%; 95% c.i. 93.5 to 99.8%; P = 0.256). Mean(s.d.) surgeon-reported ease for using ICG and 99mTc, rated used a five-point Likert scale, was 1.67 (0.98) (95% c.i. 1.56 to 1.78) and 1.5 (0.59) (95% c.i. 1.43 to 1.57), respectively (P = 0.082). 99mTc cost an additional EUR841 (95% c.i. EUR766 to EUR917) per patient but ICG would require > 35 patients before breaking even with initial outlay equipment costs.
Conclusion: ICG fluorescence performed similarly to 99mTc lymphoscintigraphy and may be less costly over the long term.
背景:早期乳腺癌的标准前哨淋巴结(SLN)定位包括锝-99m (99mTc)淋巴显像。吲哚菁绿(ICG)荧光可以实时显示淋巴和淋巴结,同时避免辐射暴露和99mTc的不便,但其在国际指南中的纳入并不普遍。本研究比较了ICG和99mTc在腋窝SLN淋巴标测中的疗效和成本。方法:采用ICG和99mTc进行淋巴定位的早期乳腺癌临床阴性腋窝患者入组一项前瞻性单机构单臂非随机试验(2021-2024)。收集sln数量的数据,包括转移淋巴结、定位失败率、成本以及外科医生报告的ICG与99mTc相比易于定位的数据。成本分析使用医疗保险项目编号和微观成本。结果:共入组305例患者,共纳入637例sln。SLN的识别率为97.8%(95%置信区间(ci。ICG为96.3 ~ 98.7%),99mTc为98.3% (95% ci . 96.9 ~ 99%)。ICG和99mTc鉴定的sln的平均(标准差)分别为2.06个(1.99个)和2.07个(2.02个)(P = 0.871)。305例患者中有70例(23.0%)发现转移性sln,总共83例转移性sln。ICG鉴定83例转移性sln中的79例(95.2%;95% ci . 88.3 ~ 98.1%), 99mTc鉴定83例转移性sln中的82例(98.8%;95% ci . 93.5 ~ 99.8%; P = 0.256)。使用5点李克特量表评分的ICG和99mTc的平均(s.d)外科医生报告的易用性分别为1.67 (0.98)(95% ci . 1.56至1.78)和1.5 (0.59)(95% ci . 1.43至1.57)(P = 0.082)。9900万tc的成本为每位患者额外增加841欧元(95% c.i 766欧元至917欧元),但ICG需要35名患者才能达到收支平衡。结论:ICG荧光检测的效果与99mTc淋巴显像相似,从长期来看成本可能更低。
{"title":"Indocyanine green versus technetium-99m for sentinel lymph node biopsy in breast cancer: the FLUORO trial.","authors":"Chu Luan Nguyen, Jianing Kwok, Michael Zhou, Neshanth Easwaralingam, Jue Li Seah, Belinda Chan, Susannah Graham, Farhad Azimi, Cindy Mak, Carlo Pulitano, Sanjay Warrier","doi":"10.1093/bjsopen/zraf104","DOIUrl":"10.1093/bjsopen/zraf104","url":null,"abstract":"<p><strong>Background: </strong>Standard sentinel lymph node (SLN) mapping for early breast cancer involves technetium-99m (99mTc) lymphoscintigraphy. Indocyanine green (ICG) fluorescence allows real-time visualization of lymphatics and nodes while avoiding radiation exposure and the inconvenience of 99mTc, but its inclusion in international guidelines is not widespread. This study compared efficacy and costs between ICG and 99mTc for axillary SLN lymphatic mapping.</p><p><strong>Methods: </strong>Patients with early breast cancer and clinically negative axilla who underwent lymphatic mapping with ICG and 99mTc were enrolled in a prospective single-institution single-arm non-randomized trial (2021-2024). Data on the number of SLNs, including metastatic nodes, rate of failed mapping, costs, and the surgeon's reported ease of mapping with ICG compared with 99mTc were collected. Cost analysis used Medicare item numbers and microcosting.</p><p><strong>Results: </strong>A total of 305 patients were enrolled, with 637 SLNs sampled. The SLN identification rate was 97.8% (95% confidence interval (c.i.) 96.3 to 98.7%) for ICG and 98.3% (95% c.i. 96.9 to 99%) for 99mTc. The mean(standard deviation (s.d.)) number of SLNs identified with ICG and 99mTc was 2.06 (1.99) and 2.07 (2.02), respectively (P = 0.871). Metastatic SLNs were identified in 70 of 305 patients (23.0%), with 83 metastatic SLNs in total. ICG identified 79 of 83 metastatic SLNs (95.2%; 95% c.i. 88.3 to 98.1%) and 99mTc identified 82 of 83 metastatic SLNs (98.8%; 95% c.i. 93.5 to 99.8%; P = 0.256). Mean(s.d.) surgeon-reported ease for using ICG and 99mTc, rated used a five-point Likert scale, was 1.67 (0.98) (95% c.i. 1.56 to 1.78) and 1.5 (0.59) (95% c.i. 1.43 to 1.57), respectively (P = 0.082). 99mTc cost an additional EUR841 (95% c.i. EUR766 to EUR917) per patient but ICG would require > 35 patients before breaking even with initial outlay equipment costs.</p><p><strong>Conclusion: </strong>ICG fluorescence performed similarly to 99mTc lymphoscintigraphy and may be less costly over the long term.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12527340/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145298244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}