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Background: Surgical interventions for pancreatic cancer are complex due to numerous interacting components. This complexity can make the design and conduct of randomized clinical trials (RCTs) challenging due to variations in how surgical interventions are delivered across centres and surgeons. Quality assurance (QA) methods, such as those described within the CONSORT recommendations for non-pharmacological interventions (CONSORT-NPT), attempt to mitigate this. The extent of the adoption of such QA methods in RCTs evaluating surgical interventions for pancreatic cancer is unclear.

Methods: A systematic review was conducted on multicentre RCTs evaluating surgical interventions for pancreatic cancer. Data were extracted within four QA domains described within the CONSORT-NPT checklist: surgical intervention description, standardization, adherence, and clinician and unit expertise.

Results: Of 2374 studies identified, 45 were eligible for inclusion in this review. Thirty-eight RCTs (84%) described the intervention and 20 (44%) attempted to standardize techniques. Information about permitted flexibility in surgical interventions was described in 14 RCTs (31%). Fourteen studies (31%) described methods used to measure adherence to the intervention, with intra-operative photographs/videos (ten studies) being the most common. Nineteen studies (42%) detailed surgeon or unit expertise, and six (13%) used credentialing criteria.

Conclusion: Although most RCTs described the intervention, reporting on standardization, adherence, and expertise was often lacking. This may affect RCT results and compromise the extent to which observed differences in clinical outcomes are due to the actual intervention being delivered. More rigorous application and reporting of QA measures are needed to improve confidence in the results of future RCTs, which may, in turn, enhance implementation in clinical practice.

Background: Compliance with enhanced recovery after surgery (ERAS) protocols in gastrectomy, including urinary catheter management, remains poor. This study evaluated the feasibility of immediate urinary catheter removal after radical gastrectomy.

Methods: This was a non-inferiority randomized clinical trial performed at a university-affiliated hospital in China. Patients undergoing radical gastrectomy were randomized in a 1 : 1 ratio to either immediate removal (IR) or early removal (ER) of the urinary catheter. The randomization sequence was computer generated; the investigators and patients were not blinded to group allocation. ERAS protocols were applied in all patients. The primary outcome measure was postoperative urinary retention with a non-inferiority margin of 10% to compare IR with ER. Secondary outcomes were patient comfort, patient anxiety, and depression. Data were analysed using intention-to-treat analysis.

Results: Initially, 248 patients were assessed for eligibility for this study. Data were analysed for 92 patients in the IR group and 89 patients in the ER group. The incidence of postoperative urinary retention was 4.4% and 3.4% in the IR and ER groups, respectively (P = 0.733; 1.0% difference, 95% confidence interval -4.6 to 6.6%). Patient comfort levels were significantly higher in IR than ER group (mean(standard deviation) Kolcaba General Comfort Questionnaire score 74.9(7.6) versus 72.5(8.0), respectively; P = 0.041).

Conclusion: IR of the urinary catheter after gastrectomy is feasible under ERAS perioperative care protocols. It does not increase the incidence of postoperative urinary retention and can provide a more comfortable postoperative experience. Successful IR implementation probably relies on multimodal analgesia and goal-directed fluid therapy.

Registration number: NCT06718114 (http://www.clinicaltrials.gov).

Background: The primary aim of this study was to establish the incidence of implant-related operations and revisions after delayed implant-based breast reconstruction over a 20-year period.

Methods: This study is an ancillary study to the Gothenburg Breast Reconstruction Study (GoBreast; NCT03963427). The first included patient was operated on in 2003, and the last was operated on in 2011. All breast reconstructions were delayed procedures. The Kaplan-Meier method was used to estimate the time until implant loss. Log-rank tests (Mantel-Haenszel) were used for comparisons. A Cox proportional hazards model was used for multivariable analysis, and hazard ratios were estimated.

Results: The study included 881 implants and 603 patients. The mean follow-up for the implants was 8.2 years. With regard to first implants, 17% had at least one unplanned procedure with implant failure. If all implants are pooled together, the 20-year implant survival rate is 57% (95% confidence interval 54 to 61%). Most implants were lost during the first 2 years, but the cumulative risk of implant loss increased steadily with time. When different surgical methods were compared, implant survival was statistically lower for direct-to-implant than for the other techniques (P < 0.001).

Conclusion: About half of the implants in delayed breast reconstructions in this study survived for up to two decades without any additional surgery. Serial implant revisions seem more common than single implant revisions; if the first implant needed revision, there was a tendency for the second implant to also require revision.

Background: Sentinel lymph node biopsy provides information about disease staging and the need for adjuvant therapy. The consequences of a false-negative result are potentially severe. The risk of a false-negative result should be quantified. The aims of this study were to estimate the sensitivity of sentinel lymph node biopsy based on studies following up patients for at least a mean or median of 5 years, appraise the risk of bias, and provide negative predictive value estimates across a range of pretest probabilities.

Methods: Ovid MEDLINE and Embase databases were searched from inception to 28 May 2025. Studies were screened independently and in duplicate, with a third author resolving conflicts. All original comparative and non-comparative English language research studies were included if the sensitivity of sentinel lymph node biopsy was calculable and participants had been followed up for a mean or median of 5 years. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Sensitivity estimates were calculated and pooled by random-effects meta-analysis. A negative predictive value curve was plotted using the pooled sensitivity estimate and a range of plausible pretest probabilities.

Results: Fourteen studies with 8447 patients were included. The pooled sensitivity estimate was 0.85 (95% confidence interval 0.80 to 0.88). The negative predictive value estimates fell between 0.93 and 0.97, depending on pretest probability. Existing negative predictive value estimates are at risk of positive bias.

Conclusion: Sentinel lymph node biopsy is a sensitive test used to rule out lymph node metastasis in cutaneous melanoma. Clinicians can use negative predictive value estimates to counsel patients about the probability of false-negative results, for example, by offering reassurance to patients with thin melanomas and negative sentinel lymph node biopsy.

Background: Cholecystectomy is a common procedure with a notable risk of iatrogenic bile duct injury. Understanding the factors contributing to bile duct injury and the effectiveness of preventative measures is crucial for improving surgical outcomes. This meta-analysis aimed to identify and synthesize high-quality evidence on risk factors and mitigating measures associated with bile duct injury after cholecystectomy.

Methods: Following the PRISMA guidelines, a comprehensive literature search was conducted across multiple databases. Included studies reported on adult patients undergoing cholecystectomy with relevant risk factors for bile duct injury. Meta-analyses of unadjusted and adjusted risk estimates were conducted with a random-effects model to account for heterogeneity. The study period across all included studies spanned from 1989 to 2016.

Results: The review included 31 studies comprising 6 513 599 cholecystectomies and 18 259 bile duct injuries. The primary risk factors identified were male sex (adjusted odds ratio 1.27, 95% confidence interval 1.13 to 1.39) and acute cholecystitis (adjusted odds ratio 1.74, 1.27 to 2.39). The critical view of safety was inconsistently documented and not statistically linked to reduced bile duct injury. Intraoperative cholangiogram's routine use did not show a statistically significant association with reduced incidence of bile duct injury (adjusted odds ratio 0.92, 0.70 to 1.23).

Conclusion: Male sex and acute cholecystitis significantly increase the risk of bile duct injury after cholecystectomy. Risk stratification for these patients before surgery would ultimately aid the shared decision-making consent process.

Background: Neoadjuvant chemotherapy is increasingly used in patients with locally advanced gallbladder cancer (LAGBC). This study investigated factors affecting clinical benefit response (CBR) to neoadjuvant chemotherapy for LAGBC.

Methods: All consecutive patients with LAGBC following neoadjuvant chemotherapy, from January 2013 to December 2022, were analyzed for clinical and radiological responses as well as survival outcomes. CBR rates, resectability, and their impact on survival were evaluated. In addition, factors predicting CBR were identified and a predictive nomogram model was developed.

Results: Of 401 patients with LAGBC undergoing neoadjuvant chemotherapy, 303 (75.5%) exhibited a CBR. The median overall survival (OS) in patients with a CBR was 25 months, compared with 8.5 months for those without a CBR. Factors predicting a worse CBR rate included age ≥ 55.5 years (hazard ratio (HR) 2.17; 95% confidence interval (c.i.) 1.29 to 3.65), Eastern Cooperative Oncology Group (ECOG) performance status ≥ 1 (HR 2.5; 95% c.i. 1.117 to 5.59), platelet count ≥ 468 × 109/l (HR 2.86; 95% c.i. 1.12 to 6.74), tumour (T) size ≥ 2.1 cm (HR 3.4; 95% c.i. 1.70 to 6.80), T stage ≥ T3 (HR 3.26; 95% c.i. 1.22 to 8.74), and a systemic immune-inflammation index (SII) ≥ 1265.90 (HR 2.34; 95% c.i. 1.27 to 4.30). Of the patients with a CBR, 86% underwent curative surgical resection, with median OS improved to 29.54 months, compared with 11.86 months for those without resection (P < 0.01).

Conclusion: A CBR was achieved in 75.5% of patients, with curative surgical resection in 86%. A CBR was associated with improved OS. Anatomical (T size, T stage) and immune-inflammation markers (platelet count, SII) were found to predict a CBR, and could help identify responders to neoadjuvant chemotherapy. This could have implications for treatment strategies, but requires validation in further prospective studies.

Background: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy is an effective but potentially highly morbid treatment option for peritoneal surface malignancies. Adequate risk assessment is fundamental for clinical decision-making and informed patient consent. The aim of this study was to construct a validated nomogram predicting the risk of severe postoperative complications based exclusively on preoperative variables.

Methods: A prospective database of patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in a single institution between February 1995 and April 2023 was reviewed. The cohort was divided randomly into derivation and validation cohorts (70 : 30). The primary outcome measure was postoperative complications (National Cancer Institute Common Terminology Criteria for Adverse Events grade ≥ 3). Binary logistic regression identified preoperative variables significantly associated with postoperative morbidity. A nomogram was constructed based on the results of the multivariable analysis. The model's performance was evaluated on the validation cohort by receiver operating characteristic curve analysis.

Results: A total of 1039 patients were analysed. The majority of the patients were female (58.8%) and the median age was 56 (interquartile range 46-64) years. The postoperative complication rate was 37.7%, and the reoperation rate 12.7%. A nomogram was constructed based on the following predictive factors: age, body mass index, high-grade histology, disease identified in the left upper quadrant and surrounding the stomach and small bowel mesentery on preoperative imaging, preoperative white blood cell count, and Onodera nutritional index score. Receiver operating characteristic curve analysis showed an area under the curve of 0.707 with accurate calibration curves.

Conclusion: Preoperative variables were selected and included in a simple nomogram predicting the risk of postoperative complications. This nomogram could aid clinicians in decision-making and patients in making informed decisions.

Background: Postoperative adhesions following thyroidectomy significantly affect patient quality of life, yet prevention strategies remain understudied. This trial evaluated the safety and efficacy of oxidized regenerated cellulose and high molecular weight hyaluronic acid in preventing post-thyroidectomy adhesions.

Methods: In this prospective, single-blinded, randomized study, patients undergoing thyroidectomy were randomized 1 : 1 : 1 to receive oxidized regenerated cellulose (Interceed™), high molecular weight hyaluronic acid (HANBIO BarriGel), or no adhesion barrier (control). The primary outcome was change in the Dysphagia Handicap Index (DHI) from baseline to 1 month. Secondary outcomes included the Voice Handicap Index, Swallowing Impairment Score, laryngotracheal elevation, and adhesion severity scores at 2 weeks, and 1, 6, and 12 months after operation.

Results: Forty -five patients were enrolled. Changes in DHI were not significant from baseline to 1 month among the three groups. The adhesion barrier groups demonstrated significantly smaller increases in Voice Handicap Index scores compared with the control group at 2 weeks (oxidized regenerated cellulose: mean(s.d.) 4.8(5.8); high molecular weight hyaluronic acid: 0.8(6.3); control: 8.4(9.6); P = 0.032) and at 1 month (3.0(5.2), 1.0(7.1), and 9.1(12.3), respectively; P = 0.047). Changes in Swallowing Impairment Scores were significantly lower in the adhesion barrier groups (2.1(5.6) versus 6.0(5.9); P = 0.037), although no significant differences were observed among the three groups (oxidized regenerated cellulose: 1.4(4.2); high molecular weight hyaluronic acid: 2.8(6.8); control: 6.0(5.9); P = 0.095) at 2 weeks. The high molecular weight hyaluronic acid group demonstrated superior preservation of laryngotracheal elevation among groups (P = 0.006) and compared with the oxidized regenerated cellulose group (P = 0.041) at 1 month. No adhesion barrier-related complications were observed. By 6 months, most parameters had returned to near-baseline levels across all groups.

Conclusion: Both oxidized regenerated cellulose and high molecular weight hyaluronic acid appear safe and potentially effective in reducing early post-thyroidectomy adhesion symptoms, with high molecular weight hyaluronic acid showing superior outcomes in certain parameters. These findings support the use of adhesion barriers in thyroid surgery, although larger studies are needed to confirm their long-term benefits.

Registration number: NCT05851560 (http://www.clinicaltrials.gov).

Background: Carpal tunnel release (CTR) can be performed using either an open or endoscopic approach. The patient recovery trajectories remain poorly understood. This study aimed to define and compare patient-reported recovery following unilateral open and endoscopic CTR.

Methods: A PRISMA-compliant, preregistered (CRD42023427718) systematic review was conducted, searching PubMed, Embase, and Cochrane databases on 4 July 2023 and 21 August 2024. Studies were included if they reported recovery data (patient-reported outcome measures (PROMs)) at predefined time points for adults undergoing unilateral CTR. Boston Carpal Tunnel Questionnaire and Quick Disabilities of Arm, Shoulder, and Hand scores were extracted. Standardized mean change (SMC) scores from baseline were pooled using random-effects meta-analysis. An innovative modification of the National Institutes of Health quality assessment tools was used to evaluate the risk of bias.

Results: In all, 49 studies were included (4546 participants included in the analysis; 3137 open CTR, 1409 endoscopic CTR). Both approaches improved PROM scores over 12 weeks, with early (4-week) outcomes strongly correlating (>0.89) with later (12-week) outcomes. Symptoms continued improving up to 104 weeks. At 1 week, open CTR showed symptomatic deterioration (SMC 10.29; 95% confidence interval (c.i.) 6.35 and 14.21 respectively), comparatively, endoscopic CTR demonstrated an improvement (SMC -2.83; 95% c.i. -7.80 and 2.14 respectively). By 2 weeks, symptom severity remained slightly worse in open CTR, but confidence intervals overlapped from week 3 and thereafter open CTR showed greater symptomatic improvement. Most studies had a high risk of bias and measured outcomes too infrequently for a granular comparison.

Conclusions: Patient-reported recovery trajectories for CTR can inform patient counselling and future research. Endoscopic CTR may result in fewer symptoms in the first 2 weeks, but open CTR may offer comparable or potentially greater improvement thereafter. Future trials with high-frequency PROM capture should prioritize early (first 3 weeks) and long-term (≥24 weeks) outcomes.

Background: Emergency laparotomy is performed for a wide range of life-threatening conditions and is associated with significant morbidity and mortality. Risk prediction models facilitate accurate communication of operative risk with patients and relatives, in addition to benchmarking unit outcomes. Greater understanding of the impact of sarcopenia or myosteatosis will encourage the adoption of routine radiological reporting of body composition and the incorporation of skeletal muscle gauge (SMG) into risk prediction models. This study investigated the prognostic significance of SMG, an aggregate assessment of sarcopenia or myosteatosis, in patients who had undergone an emergency non-trauma-related laparotomy.

Methods: This was a retrospective cohort study of patients aged ≥ 18 years who underwent an emergency laparotomy at the Queen Elizabeth Hospital between January 2014 and December 2020. Body composition and patient outcomes were analysed.

Results: In all, 1090 patients with a mean(standard deviation) age of 62.3(17.5) years underwent emergency laparotomy (bowel obstruction, 52.7%; perforation, 26.3%; ischaemia, 9.5%). Overall 30- and 90-day mortality was 10.0% and 11.6%, respectively. On multivariate analysis, low SMG was associated with worse 30- and 90-day mortality, with odds ratios of 2.12 (95% confidence interval (c.i.) 1.18 to 3.83; P = 0.012) and 2.64 (95% c.i. 1.55 to 4.48; P < 0.001), respectively. Low SMG was also associated with an increased length of hospital stay (odds ratio 1.45; 95% c.i. 1.22 to 1.72; P < 0.001).

Conclusion: A low SMG was associated with increased postoperative mortality and length of hospital stay after emergency laparotomy. Patients undergoing computed tomography imaging for acute abdominal pain should undergo routine reporting of body composition.