Randomised feasibility trial of outpatient versus inpatient laparoscopic cholecystectomy for benign gallbladder disease (OUTchol): study protocol.

Abstract

Cholecystolithiasis is a common condition and most cases are asymptomatic. In symptomatic cases, gallstone disease results in hospitalisation and significant healthcare costs. Laparoscopic cholecystectomy is the standard treatment and is traditionally performed in an inpatient setting. Recent studies indicate that outpatient laparoscopic cholecystectomy may offer comparable safety and effectiveness yet the feasibility and cost-effectiveness are not conclusively defined. This randomised-controlled, open-label feasibility trial will be conducted at two surgical centres in Thurgau, Switzerland. A total of 50 participants will be randomly assigned (1:1) to receive either outpatient or inpatient laparoscopic cholecystectomy. The primary endpoints include feasibility, safety and cost-effectiveness. Secondary endpoints assess mortality, postoperative complications, reinterventions and readmission rates, emergency department visits, pain, length of hospital stay, time to return to work and additional healthcare resource utilisation. The total follow-up will be 14 days. The study has been approved by the local ethics committee and is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be disseminated through peer reviewed publications and conference presentations. DRKS00039001.