Multicenter Cohort of 768 High-risk Patients With Symptomatic Gallstones, Adding Cholecystectomy Did Not Increase Length of Stay or Perioperative Morbidity, Supporting it as a Safe Single-stage Option

Data was collected from the archived medical records of the surgical departments of allthe three research centers (in Zagazig city, Egypt, and the Najran University Hospital,Najran city, Saudi Arabia), and were retrospectively analyzed for all patients withinclusion criteria and the laparoscopic sleeve gastrectomy was done, with or withoutconcomitant laparoscopic cholecystectomy during the period from January 2015 to January2025 (the study period).Patients were divided into: ‐ Group A (LSG alone): High‐risk patients with symptomatic stones who underwent LSGwithout cholecystectomy. ‐ Group B (LSG with concomitant cholecystectomy): High‐risk patients with symptomaticstones who underwent LSG and simultaneous laparoscopic cholecystectomy.The decision to perform concomitant cholecystectomy was clinical, based on surgeonpreference, patient consent, and intraoperative findings. Group A patients were those inwhom the surgeon opted to defer cholecystectomy due to concerns about operative time,complexity, patient refusal, or significant comorbidities that might increase the risk ofa combined procedure. This selection bias was addressed using propensity‐score matching.A total of 2,512 patients underwent LSG during the study period across the three centres[1,452 at Zagazig University Hospitals, 567 at Al‐Ahrar Teaching Hospital, and 493 atNajran University Hospital]. Among them, 805 patients (32.1%) met the high‐risk criteria(≥ 3 comorbidities, age ≥ 55 years, or ASA ≥ III) and had symptomatic cholelithiasis. Ofthese, 518 (64.3%) underwent LSG alone (Group A), and 287 (35.7%) underwent concomitantcholecystectomy (Group B). After excluding 37 patients lost to 30‐day follow‐up (23 fromGroup A, 14 from Group B), the final analysis included 495 patients in Group A and 273patients in Group B. See the flow chart for the allocation process throughout the studyPostoperative Care and Outcome Measures All patients followed an enhanced recovery aftersurgery (ERAS) protocol: early mobilization, multimodal analgesia, and gradual dietaryprogression. Discharge criteria included tolerance of oral intake, adequate pain control,and afebrile status.The primary outcome was overall 30 day postoperative complication rate, while secondaryoutcomes were: ‐ Operative time (skin incision to skin closure) ‐ Length of hospital stay (LOS) ‐ Specific complications: bleeding (requiring transfusion or reoperation), surgicalsite infection (superficial/deep), staple line leakage, bile leak, trocar siteeventration (previously termed "port site hernia") ‐ 30 day readmission and reoperation rates ‐ 30 day mortality ‐ Clavien Dindo grade of complications Data Collection Data were extracted fromelectronic medical records, operative logs, and outpatient charts using astandardised form. Variables included demographics, BMI, comorbidities, ASA class,preoperative ultrasound findings, operative details, intraoperative events, and 30day outcomes. Loss to follow up was defined as no documented contact or clinic visitwithin 30 days post discharge.Statistical analysis Continuous variables were expressed as mean ± standard deviation(SD) or median with interquartile range (IQR) and compared using Student's t‐test orMann‐Whitney U test. Categorical variables were expressed as frequencies and percentagesand compared using chi‐square or Fisher's exact test (with Fisher's exact test used forcomparisons with expected cell counts <5). A p‐value <0.05 was considered significant. Toaccount for multiple comparisons, the Bonferroni correction was applied; a correctedp‐value <0.003 was considered significant for the 15 comparisons. Post‐hoc power analysiswas performed: based on the observed overall complication rates (5.5% vs 5.9%) and samplesizes (n=495 and 273), the study had approximately 85% power to detect a 5% absolutedifference in overall complications (α=0.05, two‐tailed). For rare events (e.g., stapleline leakage), the study was underpowered.To address selection bias, propensity‐score matching was performed using the followingcovariates: age, sex, BMI, number of comorbidities, ASA class, gallbladder wallthickness, and history of acute cholecystitis. Patients were matched 1:1 using a caliperof 0.2 of the standard deviation of the logit of the propensity score. Standardised meandifferences (SMD) were calculated before and after matching; SMD <0.1 indicated goodbalance.Multivariable logistic regression was performed to identify independent predictors ofoverall complications, with concomitant cholecystectomy as the primary variable ofinterest, adjusting for age, sex, BMI, number of comorbidities, ASA class, gallbladderwall thickness, history of acute cholecystitis, and centre. Adjusted odds ratios (OR)with 95% confidence intervals (CI) were reported.Sensitivity analyses included: (1) centre‐stratified analysis using random‐effectsmeta‐analysis; (2) temporal trend analysis by year of surgery; (3) subgroup analyses byeach component of the high‐risk definition (age ≥55, ≥3 comorbidities, ASA ≥III); (4)exclusion of patients with acute cholecystitis; and (5) stratification by proceduralsequence (cholecystectomy‐first vs. sleeve‐first) in Group B.All analyses were performed using SPSS version 22.0 (IBM Corp., Armonk, NY, USA) and Rversion 4.2.1 (R Foundation for Statistical Computing, Vienna, Austria).