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NOT YET RECRUITING
NCT07153419
NA

Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

The objective of this randomized controlled trial is to compare perioperative outcomes between laparoscopic and robotic approaches in patients with severe obesity who are candidates for RYGB. The trial aims to address the following key questions: To evaluate the difference between the two procedures in terms of postoperative complications. To assess intraoperative complications, conversion rate, mortality, operative times, postoperative hospital stay, and cost analysis for both approaches. In summary, the researchers will compare the laparoscopic and robotic approaches to determine which one leads to better perioperative outcomes

Official title: Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass: A Non-inferiority Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

512

Start Date

2026-01

Completion Date

2028-10

Last Updated

2025-09-04

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Laparoscopic and robotic (DaVinci) RYGB

Laparoscopic and robotic (DaVinci) Roux-en-Y Gastric Bypass

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy