A value of < 0.05 was considered statistically significant. Normality was tested using Kolmogorov Smirnoff test. To study the effect of a range of patient-specific, surgeon-specific, and facility-specific variables on 30-day morbidity and mortality.ĭata were analysed using IBM SPSS version 26 and Jamovi version 1.8.4. To assess procedure-specific complication rates such as bleeding, bile leak, bowel injury, bile duct injury, and conversion to open surgery. Operations performed outside the study periodģ0-day morbidity and mortality of patients undergoing LC in India. Patients undergoing cholecystectomy for malignancy LC for benign gallbladder disease performed with other procedures like hernia surgery, appendectomy, and hysterectomy was included in the study (but not the removal of a normal gallbladder as part of other surgery like Whipple's). LC as a primary procedure for benign symptomatic gallbladder disease
Individual datasheets were carefully examined for errors, and any doubts were clarified with collaborators. Anonymised patient data were collected using a Microsoft Excel® database as approved by the core team. Individual centres were recommended to follow local regulations and obtain additional permissions as needed. Contributing Surgeons took part in a Zoom® meeting held to describe the study design and data capturing required for the study.
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Regulatory approval and data collectionĮthics committee permission was obtained at the leading primary Institute: (IRB: JLHL/IEC/2020), and the study was registered with the Clinical trial of Research of India (Registration number CTRI/2048). 30-day follow-up data were collected for each patient. Participating surgeons submitted data on all consecutive LC performed by them between and in adult patients for benign gallbladder pathologies. Google forms soliciting surgeons’ participation were circulated via social media and IAGES membership communication channels. This was a multicentre, prospective, observational, cohort study. LC has 30-day morbidity of 11.1%, 30-day mortality of 0.2%, conversion to open rate of 1.4%, and bile duct injury rate of 0.3% in India. Age, weight, body mass index, duration of symptoms, nature of the practice, history of Coronavirus Disease-2019, previous major abdominal surgery, acute cholecystitis, use of electrosurgical or ultrasonic or bipolar energy for cystic artery control use of polymer clips for cystic duct control conversion to open surgery, subtotal cholecystectomy, simultaneous common bile duct exploration, mucocele, gangrenous gall bladder, dense adhesions, intraoperative cholangiogram, and use of drain were independently associated with 30-day morbidity. Nature of practice, ischemic heart disease, emergency surgery, postoperative intensive care, and postoperative hospital stay were independently associated with 30-day mortality. Bile duct injury was seen in 0.3% ( n = 20). Laparoscopic subtotal cholecystectomy was performed in 1.9% ( n = 126) and the procedure were converted to open in 1.4% of patients. A total LC was carried out in 95% ( n = 6331).
ResultsĪ total of 293 surgeons from 125 centres submitted data on 6666 patients.
Univariate and multivariate analyses were performed to identify variables significantly associated with primary outcomes. Primary outcome measures were 30-day morbidity and mortality. Participating surgeons were invited to submit data on all consecutive LCs for benign diseases performed between and in adults. A prospective multicentre observational study was conducted by the Indian Association of Gastro-Intestinal Endo Surgeons (IAGES) to assess the 30-day morbidity and mortality of LC in India. There are no robust Indian data on the 30-day morbidity and mortality of this procedure. Laparoscopic cholecystectomy (LC) is the standard of care for benign gallstone disease.
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