Pub Date : 2024-11-01DOI: 10.1001/jamasurg.2024.3498
David C Cron, Rafal D Mazur, Irun Bhan, Joel T Adler, Heidi Yeh
Importance: Women on the liver transplant waiting list are less likely to undergo a transplant than men. Recent approaches to resolving this disparity have involved adjustments to Model for End-Stage Liver Disease (MELD) scoring, but this will not affect candidates who rely on exception scores rather than calculated MELD score, the majority of whom have hepatocellular carcinoma (HCC).
Objective: To evaluate the association between female sex, candidate size, and access to liver transplant among wait-listed patients with HCC.
Design, setting, and participants: This retrospective cohort study used US transplant registry data of all adult (aged ≥18 years) wait-listed liver transplant candidates receiving an HCC exception score between January 1, 2010, and March 2, 2023.
Main outcomes and measures: The association of female sex with (1) deceased-donor liver transplant (DDLT) and (2) death or waiting list removal for health deterioration were estimated using multivariable competing-risks regression. Results with and without adjustment for candidate height and weight (mediators of the sex disparity) were compared.
Results: The cohort included 31 725 candidates with HCC (mean [SD] age at receipt of exception, 61.2 [7.1] years; 76.3% men). Compared with men, women had a lower 1-year cumulative incidence of DDLT (50.8% vs 54.0%; P < .001) and a higher 1-year cumulative incidence of death or delisting for health deterioration (16.2% vs 15.0%; P = .002). After adjustment, without accounting for size, women had a lower incidence of DDLT (subdistribution hazard ratio [SHR], 0.92; 95% CI, 0.89-0.95) and higher incidence of death or delisting (SHR, 1.06; 95% CI, 1.00-1.13) compared with men. When adjusting for candidate height and weight, there was no association of female sex with incidence of DDLT or death or delisting. However, at a height cutoff of 166 cm, short women compared with short men were still less likely to undergo a transplant (SHR, 0.93; 95% CI, 0.88-0.99).
Conclusions and relevance: In this study, women with HCC were less likely to receive a DDLT and more likely to die while wait-listed than men with HCC; these differences were largely (but not entirely) explained by sex-based differences in candidate size. For candidates listed with exception scores, additional changes to allocation policy are needed to resolve the sex disparity, including solutions to improve access to size-matched donor livers for smaller candidates.
{"title":"Sex and Size Disparities in Access to Liver Transplant for Patients With Hepatocellular Carcinoma.","authors":"David C Cron, Rafal D Mazur, Irun Bhan, Joel T Adler, Heidi Yeh","doi":"10.1001/jamasurg.2024.3498","DOIUrl":"10.1001/jamasurg.2024.3498","url":null,"abstract":"<p><strong>Importance: </strong>Women on the liver transplant waiting list are less likely to undergo a transplant than men. Recent approaches to resolving this disparity have involved adjustments to Model for End-Stage Liver Disease (MELD) scoring, but this will not affect candidates who rely on exception scores rather than calculated MELD score, the majority of whom have hepatocellular carcinoma (HCC).</p><p><strong>Objective: </strong>To evaluate the association between female sex, candidate size, and access to liver transplant among wait-listed patients with HCC.</p><p><strong>Design, setting, and participants: </strong>This retrospective cohort study used US transplant registry data of all adult (aged ≥18 years) wait-listed liver transplant candidates receiving an HCC exception score between January 1, 2010, and March 2, 2023.</p><p><strong>Exposure: </strong>Wait-listed liver transplant candidate sex.</p><p><strong>Main outcomes and measures: </strong>The association of female sex with (1) deceased-donor liver transplant (DDLT) and (2) death or waiting list removal for health deterioration were estimated using multivariable competing-risks regression. Results with and without adjustment for candidate height and weight (mediators of the sex disparity) were compared.</p><p><strong>Results: </strong>The cohort included 31 725 candidates with HCC (mean [SD] age at receipt of exception, 61.2 [7.1] years; 76.3% men). Compared with men, women had a lower 1-year cumulative incidence of DDLT (50.8% vs 54.0%; P < .001) and a higher 1-year cumulative incidence of death or delisting for health deterioration (16.2% vs 15.0%; P = .002). After adjustment, without accounting for size, women had a lower incidence of DDLT (subdistribution hazard ratio [SHR], 0.92; 95% CI, 0.89-0.95) and higher incidence of death or delisting (SHR, 1.06; 95% CI, 1.00-1.13) compared with men. When adjusting for candidate height and weight, there was no association of female sex with incidence of DDLT or death or delisting. However, at a height cutoff of 166 cm, short women compared with short men were still less likely to undergo a transplant (SHR, 0.93; 95% CI, 0.88-0.99).</p><p><strong>Conclusions and relevance: </strong>In this study, women with HCC were less likely to receive a DDLT and more likely to die while wait-listed than men with HCC; these differences were largely (but not entirely) explained by sex-based differences in candidate size. For candidates listed with exception scores, additional changes to allocation policy are needed to resolve the sex disparity, including solutions to improve access to size-matched donor livers for smaller candidates.</p>","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":"1291-1298"},"PeriodicalIF":15.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11375524/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1001/jamasurg.2024.3768
Kyle H Sheetz, Justin B Dimick
{"title":"Robotic or Laparoscopic Cholecystectomy-Safety First-Reply.","authors":"Kyle H Sheetz, Justin B Dimick","doi":"10.1001/jamasurg.2024.3768","DOIUrl":"10.1001/jamasurg.2024.3768","url":null,"abstract":"","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":"1330"},"PeriodicalIF":15.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142287515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1001/jamasurg.2024.3094
Manasi Tannu, Jennifer A Rymer
{"title":"Quality of Life and Clinical Outcomes in Symptomatic Peripheral Artery Disease.","authors":"Manasi Tannu, Jennifer A Rymer","doi":"10.1001/jamasurg.2024.3094","DOIUrl":"10.1001/jamasurg.2024.3094","url":null,"abstract":"","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":"1271"},"PeriodicalIF":15.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142017460","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1001/jamasurg.2024.3260
Elisa Mäkäräinen, Heikki Wiik, Maziar Nikberg, Jyrki Kössi, Monika Carpelan-Holmström, Tarja Pinta, Kirsi Lehto, Marko Nikki, Jyri Järvinen, Pasi Ohtonen, Tero Rautio
Importance: Prophylactic placement of a mesh has been suggested to prevent parastomal hernia. Evidence to support this practice is contradictory.
Objective: To determine whether funnel-shaped permanent synthetic parastomal mesh is effective and safe in parastomal hernia prevention.
Design, setting, and participants: The Chimney Trial was a randomized single-blinded multicenter trial conducted in 4 hospitals in Finland and 1 in Sweden from February 2019 and September 2021. Of 439 patients with rectal adenocarcinoma undergoing either laparoscopic or robotic-assisted abdominoperineal resection or the Hartmann procedure, 143 were enrolled in the trial, 135 received their allocated intervention, and 121 were analyzed at 12-month follow-up. Data were analyzed from December 2023 to May 2024.
Intervention: In the intervention group, a permanent colostomy was created with a funnel-shaped intraperitoneal mesh and compared to a control group with a stoma without the mesh.
Main outcome and measure: The primary end point was the incidence of computed tomography (CT)-confirmed parastomal hernia 12 months after surgery.
Results: There were 68 patients (mean [SD] age, 68.7 [11.6] years; 36 [53% male and 32 [47%] female) who received the intended allocation in the mesh group and 67 (mean [SD] age, 66.4 [11.7] years; 48 [72%] male and 19 [28%] female) who received the intended allocation in the control group. CT scans were available for 58 patients in the mesh group and 59 patients in the control group at the 12-month follow-up. CT scans confirmed parastomal hernia in 6 of 58 patients (10%) in the mesh group compared to 22 of 59 patients (37%) in the control group (difference, 27%; 95% CI, 12-41; P < .001). Clinical parastomal hernia as a secondary outcome was recorded in 1 of 60 patients (2%) in the mesh group compared to 27 of 61 (43%) in the control group (difference, 41%; 95% CI, 29-55; P < .001). The number of patients with Clavien-Dindo class II ileus was 23 (35%) in the mesh group compared to 11 (17%) in the control group (difference, 18%; 95% CI, 3-32; P = .006). Only slight differences between the groups were detected in other stoma-related complications, readmissions, operative time, surgical site infections, reoperations, and quality of life.
Conclusions and relevance: In this study, funnel-shaped parastomal mesh prevented a significant number of parastomal hernias without predisposing patients to mesh- or stoma-related complications during 12-month follow-up. The results of this study suggest the funnel-shaped mesh is a feasible option to prevent parastomal hernia.
{"title":"Parastomal Hernia Prevention Using Funnel-Shaped Intra-Abdominal Mesh Compared to No Mesh: The Chimney Randomized Clinical Trial.","authors":"Elisa Mäkäräinen, Heikki Wiik, Maziar Nikberg, Jyrki Kössi, Monika Carpelan-Holmström, Tarja Pinta, Kirsi Lehto, Marko Nikki, Jyri Järvinen, Pasi Ohtonen, Tero Rautio","doi":"10.1001/jamasurg.2024.3260","DOIUrl":"10.1001/jamasurg.2024.3260","url":null,"abstract":"<p><strong>Importance: </strong>Prophylactic placement of a mesh has been suggested to prevent parastomal hernia. Evidence to support this practice is contradictory.</p><p><strong>Objective: </strong>To determine whether funnel-shaped permanent synthetic parastomal mesh is effective and safe in parastomal hernia prevention.</p><p><strong>Design, setting, and participants: </strong>The Chimney Trial was a randomized single-blinded multicenter trial conducted in 4 hospitals in Finland and 1 in Sweden from February 2019 and September 2021. Of 439 patients with rectal adenocarcinoma undergoing either laparoscopic or robotic-assisted abdominoperineal resection or the Hartmann procedure, 143 were enrolled in the trial, 135 received their allocated intervention, and 121 were analyzed at 12-month follow-up. Data were analyzed from December 2023 to May 2024.</p><p><strong>Intervention: </strong>In the intervention group, a permanent colostomy was created with a funnel-shaped intraperitoneal mesh and compared to a control group with a stoma without the mesh.</p><p><strong>Main outcome and measure: </strong>The primary end point was the incidence of computed tomography (CT)-confirmed parastomal hernia 12 months after surgery.</p><p><strong>Results: </strong>There were 68 patients (mean [SD] age, 68.7 [11.6] years; 36 [53% male and 32 [47%] female) who received the intended allocation in the mesh group and 67 (mean [SD] age, 66.4 [11.7] years; 48 [72%] male and 19 [28%] female) who received the intended allocation in the control group. CT scans were available for 58 patients in the mesh group and 59 patients in the control group at the 12-month follow-up. CT scans confirmed parastomal hernia in 6 of 58 patients (10%) in the mesh group compared to 22 of 59 patients (37%) in the control group (difference, 27%; 95% CI, 12-41; P < .001). Clinical parastomal hernia as a secondary outcome was recorded in 1 of 60 patients (2%) in the mesh group compared to 27 of 61 (43%) in the control group (difference, 41%; 95% CI, 29-55; P < .001). The number of patients with Clavien-Dindo class II ileus was 23 (35%) in the mesh group compared to 11 (17%) in the control group (difference, 18%; 95% CI, 3-32; P = .006). Only slight differences between the groups were detected in other stoma-related complications, readmissions, operative time, surgical site infections, reoperations, and quality of life.</p><p><strong>Conclusions and relevance: </strong>In this study, funnel-shaped parastomal mesh prevented a significant number of parastomal hernias without predisposing patients to mesh- or stoma-related complications during 12-month follow-up. The results of this study suggest the funnel-shaped mesh is a feasible option to prevent parastomal hernia.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03799939.</p>","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":"1244-1250"},"PeriodicalIF":15.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11359091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142080289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1001/jamasurg.2024.3252
Imran J Anwar, Jacob A Greenberg
{"title":"Successful Prevention of Parastomal Hernia Formation With Intra-Abdominal Funnel-Shaped Mesh.","authors":"Imran J Anwar, Jacob A Greenberg","doi":"10.1001/jamasurg.2024.3252","DOIUrl":"10.1001/jamasurg.2024.3252","url":null,"abstract":"","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":"1250-1251"},"PeriodicalIF":15.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142080290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1001/jamasurg.2024.2331
Michelle N Manesh, Alexander D DiBartolomeo, Helen A Potter, Fred A Weaver, Li Ding, Gregory A Magee
{"title":"Transfusion and Anemia in Patients Undergoing Vascular Surgery.","authors":"Michelle N Manesh, Alexander D DiBartolomeo, Helen A Potter, Fred A Weaver, Li Ding, Gregory A Magee","doi":"10.1001/jamasurg.2024.2331","DOIUrl":"10.1001/jamasurg.2024.2331","url":null,"abstract":"","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":"1320-1322"},"PeriodicalIF":15.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11359097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142080313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1001/jamasurg.2024.3390
Jingjing Yu, Perisa Ruhi-Williams, Christian de Virgilio, Shahrzad Bazargan-Hejazi, Helen E Ovsepyan, Steven D Wexner, Katharine A Kirby, Fatemeh Tajik, Angelina Lo, Aya Fattah, Farin F Amersi, Kristine E Calhoun, Lisa A Cunningham, Paula I Denoya, Henry R Govekar, Sara M Grossi, Jukes P Namm, V Prasad Poola, Robyn E Richmond, Christine H Rohde, Mayank Roy, Tara A Russell, Nicola Sequeira, Anaar E Siletz, Tiffany N Tanner, Brian T Valerian, Maheswari Senthil
Importance: Because mentorship is critical for professional development and career advancement, it is essential to examine the status of mentorship and identify challenges that junior surgical faculty (assistant and associate professors) face obtaining effective mentorship.
Objective: To evaluate the mentorship experience for junior surgical faculty and highlight areas for improvement.
Design, setting, and participants: This qualitative study was an explanatory sequential mixed-methods study including an anonymous survey on mentorship followed by semistructured interviews to expand on survey findings. Junior surgical faculty from 18 US academic surgery programs were included in the anonymous survey and interviews. Survey responses between "formal" (assigned by the department) vs "informal" (sought out by the faculty) mentors and male vs female junior faculty were compared using χ2 tests. Interview responses were analyzed for themes until thematic saturation was achieved. Survey responses were collected from November 2022 to August 2023, and interviews conducted from July to December 2023.
Exposure: Mentorship from formal and/or informal mentors.
Main outcomes and measures: Survey gauged the availability and satisfaction with formal and informal mentorship; interviews assessed broad themes regarding mentorship.
Results: Of 825 survey recipients, 333 (40.4%) responded; 155 (51.7%) were male and 134 (44.6%) female. Nearly all respondents (319 [95.8%]) agreed or strongly agreed that mentorship is important to their surgical career, especially for professional networking (309 respondents [92.8%]), career advancement (301 [90.4%]), and research (294 [88.3%]). However, only 58 respondents (18.3%) had a formal mentor. More female than male faculty had informal mentors (123 [91.8%] vs 123 [79.4%]; P = .003). Overall satisfaction was higher with informal mentorship than formal mentorship (221 [85.0%] vs 40 [69.0%]; P = .01). Most male and female faculty reported no preferences in gender or race and ethnicity for their mentors. When asked if they had good mentor options if they wanted to change mentors, 141 (47.8%) responded no. From the interviews (n = 20), 6 themes were identified, including absence of mentorship infrastructure, preferred mentor characteristics, and optimizing mentorship.
Conclusions and relevance: Academic junior surgical faculty agree mentorship is vital to their careers. However, this study found that few had formal mentors and almost half need more satisfactory options if they want to change mentors. Academic surgical programs should adopt a framework for facilitating mentorship and optimize mentor-mentee relationships through alignment of mentor-mentee goals and needs.
{"title":"Mentorship of Junior Surgical Faculty Across Academic Programs in Surgery.","authors":"Jingjing Yu, Perisa Ruhi-Williams, Christian de Virgilio, Shahrzad Bazargan-Hejazi, Helen E Ovsepyan, Steven D Wexner, Katharine A Kirby, Fatemeh Tajik, Angelina Lo, Aya Fattah, Farin F Amersi, Kristine E Calhoun, Lisa A Cunningham, Paula I Denoya, Henry R Govekar, Sara M Grossi, Jukes P Namm, V Prasad Poola, Robyn E Richmond, Christine H Rohde, Mayank Roy, Tara A Russell, Nicola Sequeira, Anaar E Siletz, Tiffany N Tanner, Brian T Valerian, Maheswari Senthil","doi":"10.1001/jamasurg.2024.3390","DOIUrl":"10.1001/jamasurg.2024.3390","url":null,"abstract":"<p><strong>Importance: </strong>Because mentorship is critical for professional development and career advancement, it is essential to examine the status of mentorship and identify challenges that junior surgical faculty (assistant and associate professors) face obtaining effective mentorship.</p><p><strong>Objective: </strong>To evaluate the mentorship experience for junior surgical faculty and highlight areas for improvement.</p><p><strong>Design, setting, and participants: </strong>This qualitative study was an explanatory sequential mixed-methods study including an anonymous survey on mentorship followed by semistructured interviews to expand on survey findings. Junior surgical faculty from 18 US academic surgery programs were included in the anonymous survey and interviews. Survey responses between \"formal\" (assigned by the department) vs \"informal\" (sought out by the faculty) mentors and male vs female junior faculty were compared using χ2 tests. Interview responses were analyzed for themes until thematic saturation was achieved. Survey responses were collected from November 2022 to August 2023, and interviews conducted from July to December 2023.</p><p><strong>Exposure: </strong>Mentorship from formal and/or informal mentors.</p><p><strong>Main outcomes and measures: </strong>Survey gauged the availability and satisfaction with formal and informal mentorship; interviews assessed broad themes regarding mentorship.</p><p><strong>Results: </strong>Of 825 survey recipients, 333 (40.4%) responded; 155 (51.7%) were male and 134 (44.6%) female. Nearly all respondents (319 [95.8%]) agreed or strongly agreed that mentorship is important to their surgical career, especially for professional networking (309 respondents [92.8%]), career advancement (301 [90.4%]), and research (294 [88.3%]). However, only 58 respondents (18.3%) had a formal mentor. More female than male faculty had informal mentors (123 [91.8%] vs 123 [79.4%]; P = .003). Overall satisfaction was higher with informal mentorship than formal mentorship (221 [85.0%] vs 40 [69.0%]; P = .01). Most male and female faculty reported no preferences in gender or race and ethnicity for their mentors. When asked if they had good mentor options if they wanted to change mentors, 141 (47.8%) responded no. From the interviews (n = 20), 6 themes were identified, including absence of mentorship infrastructure, preferred mentor characteristics, and optimizing mentorship.</p><p><strong>Conclusions and relevance: </strong>Academic junior surgical faculty agree mentorship is vital to their careers. However, this study found that few had formal mentors and almost half need more satisfactory options if they want to change mentors. Academic surgical programs should adopt a framework for facilitating mentorship and optimize mentor-mentee relationships through alignment of mentor-mentee goals and needs.</p>","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":"1252-1260"},"PeriodicalIF":15.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11375519/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1001/jamasurg.2024.3080
Daan J Comes, Sarah Z Wennmacker, Carmen S S Latenstein, Jarmila van der Bilt, Otmar Buyne, Sandra C Donkervoort, Joos Heisterkamp, Klaas In't Hof, Jan Jansen, Vincent B Nieuwenhuijs, Pascal Steenvoorde, Hein B A C Stockmann, Djamila Boerma, Joost P H Drenth, Cornelis J H M van Laarhoven, Marja A Boermeester, Marcel G W Dijkgraaf, Philip R de Reuver
<p><strong>Importance: </strong>The 1-year results of the SECURE trial, a randomized trial comparing a restrictive strategy vs usual care for select patients with symptomatic cholelithiasis for cholecystectomy, resulted in a significantly lower operation rate after restrictive strategy. However, a restrictive strategy did not result in more pain-free patients at 1 year.</p><p><strong>Objective: </strong>To gauge pain level and determine the proportion of pain-free patients, operation rate, and biliary and surgical complications at the 5-year follow-up.</p><p><strong>Design, setting, and participants: </strong>This randomized clinical trial was a multicenter, parallel-arm, noninferiority, prospective study. Between February 2014 and April 2017, patients from 24 hospitals with symptomatic, uncomplicated cholelithiasis were included. Uncomplicated cholelithiasis was defined as gallstone disease without signs of complicated cholelithiasis, ie, biliary pancreatitis, cholangitis, common bile duct stones, or cholecystitis. Follow-up data for this analysis were collected by telephone from July 11, 2019, to September 23, 2023.</p><p><strong>Interventions: </strong>Patients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy.</p><p><strong>Main outcomes and measures: </strong>The primary, noninferiority end point was proportion of patients who were pain free as evaluated by Izbicki pain score at the 5-year follow-up. A 5% noninferiority margin was chosen. The secondary end points included cholecystectomy rates, biliary and surgical complications, and patient satisfaction.</p><p><strong>Results: </strong>Among 1067 patients, the median (IQR) age was 49.0 years (38.0-59.0 years); 786 (73.7%) were female, and 281 (26.3%) were male. At the 5-year follow-up, 228 of 363 patients (62.8%) were pain free in the usual care group, compared with 216 of 353 patients (61.2%) in restrictive strategy group (difference, 1.6%; 1-sided 95% lower confidence limit, -7.6%; noninferiority P = .18). After cholecystectomy, 187 of 294 patients (63.6%) in the usual care group and 160 of 254 patients (63.0%) in the restrictive strategy group were pain free, respectively (P = .88). The restrictive care strategy was associated with 387 of 529 cholecystectomies (73.2%) compared with 437 of 536 in the usual care group (81.5%; 8.3% difference; P = .001). No differences between groups were observed in biliary and surgical complications or in patient satisfaction.</p><p><strong>Conclusions and relevance: </strong>In the long-term, a restrictive strategy results in a significant but small reduction in operation rate compared with usual care and is not associated with increased biliary and surgical complications. However, regardless of the strategy, only two-third of patients were pain free. Further criteria for selecting patients with uncomplicated cholelithiasis for cholecystectomy and rethinking laparoscopic cholecystectomy as t
{"title":"Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones: 5-Year Follow-Up of the SECURE Randomized Clinical Trial.","authors":"Daan J Comes, Sarah Z Wennmacker, Carmen S S Latenstein, Jarmila van der Bilt, Otmar Buyne, Sandra C Donkervoort, Joos Heisterkamp, Klaas In't Hof, Jan Jansen, Vincent B Nieuwenhuijs, Pascal Steenvoorde, Hein B A C Stockmann, Djamila Boerma, Joost P H Drenth, Cornelis J H M van Laarhoven, Marja A Boermeester, Marcel G W Dijkgraaf, Philip R de Reuver","doi":"10.1001/jamasurg.2024.3080","DOIUrl":"10.1001/jamasurg.2024.3080","url":null,"abstract":"<p><strong>Importance: </strong>The 1-year results of the SECURE trial, a randomized trial comparing a restrictive strategy vs usual care for select patients with symptomatic cholelithiasis for cholecystectomy, resulted in a significantly lower operation rate after restrictive strategy. However, a restrictive strategy did not result in more pain-free patients at 1 year.</p><p><strong>Objective: </strong>To gauge pain level and determine the proportion of pain-free patients, operation rate, and biliary and surgical complications at the 5-year follow-up.</p><p><strong>Design, setting, and participants: </strong>This randomized clinical trial was a multicenter, parallel-arm, noninferiority, prospective study. Between February 2014 and April 2017, patients from 24 hospitals with symptomatic, uncomplicated cholelithiasis were included. Uncomplicated cholelithiasis was defined as gallstone disease without signs of complicated cholelithiasis, ie, biliary pancreatitis, cholangitis, common bile duct stones, or cholecystitis. Follow-up data for this analysis were collected by telephone from July 11, 2019, to September 23, 2023.</p><p><strong>Interventions: </strong>Patients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy.</p><p><strong>Main outcomes and measures: </strong>The primary, noninferiority end point was proportion of patients who were pain free as evaluated by Izbicki pain score at the 5-year follow-up. A 5% noninferiority margin was chosen. The secondary end points included cholecystectomy rates, biliary and surgical complications, and patient satisfaction.</p><p><strong>Results: </strong>Among 1067 patients, the median (IQR) age was 49.0 years (38.0-59.0 years); 786 (73.7%) were female, and 281 (26.3%) were male. At the 5-year follow-up, 228 of 363 patients (62.8%) were pain free in the usual care group, compared with 216 of 353 patients (61.2%) in restrictive strategy group (difference, 1.6%; 1-sided 95% lower confidence limit, -7.6%; noninferiority P = .18). After cholecystectomy, 187 of 294 patients (63.6%) in the usual care group and 160 of 254 patients (63.0%) in the restrictive strategy group were pain free, respectively (P = .88). The restrictive care strategy was associated with 387 of 529 cholecystectomies (73.2%) compared with 437 of 536 in the usual care group (81.5%; 8.3% difference; P = .001). No differences between groups were observed in biliary and surgical complications or in patient satisfaction.</p><p><strong>Conclusions and relevance: </strong>In the long-term, a restrictive strategy results in a significant but small reduction in operation rate compared with usual care and is not associated with increased biliary and surgical complications. However, regardless of the strategy, only two-third of patients were pain free. Further criteria for selecting patients with uncomplicated cholelithiasis for cholecystectomy and rethinking laparoscopic cholecystectomy as t","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":"1235-1243"},"PeriodicalIF":15.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11339699/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142017422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}