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

NCT07153419 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2025-09-04

No results posted yet for this study

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

Conditions

  • Morbid Obesity

Interventions

DEVICE

Laparoscopic and robotic (DaVinci) RYGB

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

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Marco Raffaelli · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2028-07-31
Completion
2028-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07153419 on ClinicalTrials.gov