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. 2024 Sep 9;25(1):601.
doi: 10.1186/s13063-024-08336-x.

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

Catherine Arvieux  1   2 , Fatah Tidadini  3   4 , Sandrine Barbois  3 , Eric Fontas  5 , Michel Carles  6 , Victor Gridel  7 , Jean-Christophe Orban  7 , Jean-Louis Quesada  8 , Alison Foote  3 , Coralie Cruzel  5 , Sabine Anthony  5 , Julie Bulsei  5 , Céline Hivelin  5 , Damien Massalou  9   10
Affiliations

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

Catherine Arvieux et al. Trials. .

Erratum in

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.

Keywords: Ambulatory surgery; Appendectomy; Outpatient surgery; Postoperative morbi-mortality; Randomized controlled trial.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flowchart
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments
See this image and copyright information in PMC

References

    1. Arvieux C, Mutter D, Varlet F. Appendicitis. Report presented at the 119th French congress of surgery. Paris, 27 to 29 September 2017. https://ebookgratuit.fr/book/appendicites-9782718414607/ Accessed 15 Nov 2022.
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    1. Di Saverio S, Birindelli A, Kelly MD, et al. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016;11:34. 10.1186/s13017-016-0090-5https://www.decitre.fr/livres/appendicites-9782718414607.html. - PMC - PubMed
    1. Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250(2):187–96. 10.1097/SLA.0b013e3181b13ca2. - PubMed
    1. Omling E, Salö M, Saluja S, et al. Nationwide study of appendicitis in children. Br J Surg. 2019;106(12):1623–31. 10.1002/bjs.11298. - PMC - PubMed

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