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 conventional inpatient care with overnight hospitalization in the surgery department. The primary outcome is postoperative morbi-mortality at D30. Secondary outcomes include time from diagnosis to appendectomy, length of total hospital stay, re-hospitalization, interventional radiology, re-interventions until D30, conversion from outpatient to inpatient, and quality of life and patient satisfaction using validated questionnaires.
Discussion
The SAMBA trial tests the hypothesis that outpatient surgery (i.e., without an overnight hospital stay) of uncomplicated acute appendicitis is a feasible and reliable procedure in establishments with a technical platform able to support this management strategy.
Trial registration
ClinicalTrials.gov NCT05691348. Registered on 20 January 2023.
You have requested "on-the-fly" machine translation of selected content from our databases. This functionality is provided solely for your convenience and is in no way intended to replace human translation. Show full disclaimer
Neither ProQuest nor its licensors make any representations or warranties with respect to the translations. The translations are automatically generated "AS IS" and "AS AVAILABLE" and are not retained in our systems. PROQUEST AND ITS LICENSORS SPECIFICALLY DISCLAIM ANY AND ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTIES FOR AVAILABILITY, ACCURACY, TIMELINESS, COMPLETENESS, NON-INFRINGMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Your use of the translations is subject to all use restrictions contained in your Electronic Products License Agreement and by using the translation functionality you agree to forgo any and all claims against ProQuest or its licensors for your use of the translation functionality and any output derived there from. Hide full disclaimer
Details
1 Grenoble Alpes University Hospital, Department of Digestive and Emergency Surgery, Grenoble, France (GRID:grid.450307.5); Lyon 1 University, Lyon Center for Innovation in Cancer, Lyon, France (GRID:grid.7849.2) (ISNI:0000 0001 2150 7757)
2 Grenoble Alpes University Hospital, Department of Digestive and Emergency Surgery, Grenoble, France (GRID:grid.450307.5)
3 University Hospital of Nice, Department of Clinical Research and Innovation, Nice, France (GRID:grid.410528.a) (ISNI:0000 0001 2322 4179)
4 University Hospital of Nice, Department of Infectious Disease, Nice, France (GRID:grid.410528.a) (ISNI:0000 0001 2322 4179)
5 University Hospital of Nice, Department of Anesthesiology, Nice, France (GRID:grid.410528.a) (ISNI:0000 0001 2322 4179)
6 INSERM CIC1406, Grenoble Alpes University Hospital, Clinical Pharmacology Unit, Grenoble, France (GRID:grid.450307.5)
7 University Hospital of Nice, Department of Visceral Surgery, Nice, France (GRID:grid.410528.a) (ISNI:0000 0001 2322 4179); Unité ICARE, Université Côte d’Azur, CNRS, Institut de Biologie Valrose, InsermNice, France (GRID:grid.460782.f) (ISNI:0000 0004 4910 6551)