Effect of endobag assisted versus conventional gallbladder extraction on bile spillage and port site surgical site infection during laparoscopic cholecystectomy: A randomized controlled trial in a gallbladder cancer endemic region

Gallbladder cancer is endemic in the northern regions of India and incidental gallbladder carcinoma is occasionally detected after laparoscopic cholecystectomy performed for gallstone disease. Bile spillage during gallbladder extraction may increase the risk of port site infection and may have implications for oncological safety in endemic regions.

This prospective randomized controlled trial aims to compare endobag assisted gallbladder extraction with conventional gallbladder extraction during laparoscopic cholecystectomy. The primary outcomes are the incidence of bile spillage occurring specifically during the gallbladder extraction phase and the incidence of port site surgical site infection within thirty days after surgery.

Adult patients undergoing elective laparoscopic cholecystectomy for gallstone disease will be randomized into two groups. In the intervention group gallbladder extraction will be performed using a sterile endobag, while in the comparator group extraction will be performed without an endobag. Secondary outcomes include bile culture positivity, intra abdominal collections related to bile leak, requirement for fascial extension of the extraction port, early port site hernia, and incidence of incidental gallbladder carcinoma on histopathology.

The study is conducted at a tertiary care teaching hospital in a gallbladder cancer endemic region of India with a planned total sample size of one thousand forty participants.