SAME day amBulatory c (SAMBA): a multicenter, prospective, randomized clinical trial protocol.

ABSTRACT:

Background

A recent meta-analysis concluded that outpatient appendectomy appears feasible and safe, but there is a lack of high-quality evidence and a randomized trial is needed. The aim of this trial is to demonstrate that outpatient appendectomy is non-inferior to conventional inpatient appendectomy in terms of overall morbi-mortality on the 30th postoperative day (D30).

Methods

SAMBA is a prospective, randomized, controlled, multicenter non-inferiority trial. We will include 1400 patients admitted to 15 French hospitals between January 2023 and June 2025. Inclusion criteria are patients aged between 15 and 74 years presenting acute uncomplicated appendicitis suitable to be operated by laparoscopy. Patients will be randomized to receive outpatient care (day-surgery) or con

SUBMITTER: Arvieux C 

PROVIDER: S-EPMC11386361 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature