Robot vs. Surgeon's hands: which gastric bypass is safer?

NCT ID NCT07153419

Not yet recruiting Disease control Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study will compare two types of minimally invasive gastric bypass surgery for people with severe obesity: one done with a robot (DaVinci) and the other done by hand (laparoscopy). Researchers want to see which approach leads to fewer complications and is more cost-effective. The trial plans to enroll 512 adults and will track outcomes like early complications, hospital stay, and costs.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: robot-assisted (DaVinci) and laparoscopic Roux-en-Y gastric bypass surgery
What this could lead to: If successful, this could show which surgical approach is safer and more cost-effective for treating severe obesity.
What could go wrong: This is a non-inferiority trial, so it may only prove the robot is not worse than laparoscopy, not necessarily better. Results may not apply to other bariatric procedures.

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Conditions

The condition(s) this trial relates to.

morbid obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MORBID OBESITY

Contacts and locations

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

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