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

Area of Science:

• Surgical innovation
• Clinical trials methodology
• Gastrointestinal surgery

Background:

• Previous meta-analysis suggests outpatient appendectomy is feasible and safe.
• Lack of high-quality evidence necessitates a randomized controlled trial.
• Outpatient appendectomy aims to reduce healthcare costs and improve patient experience.

Purpose of the Study:

• To demonstrate non-inferiority of outpatient appendectomy versus inpatient appendectomy.
• Primary endpoint: overall morbi-mortality at 30 days post-operation (D30).
• To assess feasibility and reliability of outpatient appendectomy for uncomplicated acute appendicitis.

Main Methods:

• Prospective, randomized, controlled, multicenter non-inferiority trial (SAMBA).
• 1400 patients (15-74 years) with acute uncomplicated appendicitis undergoing laparoscopy.
• Randomization to outpatient (day-surgery) or inpatient care; primary outcome D30 morbi-mortality.

Main Results:

• Data collection ongoing; results not yet available.
• Study duration: January 2023 - June 2025.
• Secondary outcomes include re-hospitalization, re-interventions, and patient-reported outcomes.

Conclusions:

• The SAMBA trial will provide crucial evidence on outpatient appendectomy.
• Findings will inform clinical practice and hospital management strategies.
• Successful implementation relies on adequate technical infrastructure.