Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass: A Non-inferiority Randomized Controlled Trial
| Registry | NCT07153419, acronym LvRRYGB |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 512 (Estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other) |
| Conditions | Morbid Obesity |
| Interventions | Laparoscopic and robotic (DaVinci) RYGB (Device) |
| Dates | start 2026-01-01 (estimated), primary completion 2028-07-01 (estimated), completion 2028-10-01 (estimated), first posted 2025-09-04, last updated 2025-09-04 |
| Locations | 1 site in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Morbid Obesity All trials of Laparoscopic and robotic (DaVinci) RYGB
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
Treating patients with pathological obesity has always posed a challenge for bariatric surgeons due to their increased risk of post-operative complications and varying short-term outcomes depending on the chosen procedure. Currently, there are no established guidelines to dictate which procedure is optimal for a given clinical presentation. Surgeons typically make this decision based on their expertise and the patient's characteristics. The most frequently performed procedures worldwide are sleeve gastrectomy and Roux-en-Y gastric bypass, with the latter validated by numerous long-term studies as a safe and effective bariatric and metabolic option for patients with a BMI <50 kg/m2. However, the complexity of Roux-en-Y gastric bypass, which requires the creation of two anastomoses during the reconstruction phase, which might be challenging when performed laparoscopically, may be facilitated by a robotic approach. Although some studies suggest that these approaches have equivalent safety and efficacy profiles, conclusive evidence evaluating their economic impact remains elusive. Consequently, the objective of the present study is to compare morbidity between the laparoscopic and robotic approach in patients undergoing Roux-en-Y gastric bypass.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Laparoscopic RYGB | Active comparator | Device: Laparoscopic and robotic (DaVinci) RYGB | Patients undergoing Roux-en-Y gastric bypass (RYGB) surgery performed laparoscopically. |
| Robotic RYGB | Experimental | Device: Laparoscopic and robotic (DaVinci) RYGB | Patients undergoing Roux-en-Y gastric bypass (RYGB) surgery performed using the DaVinci robotic platform. |
Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers
Inclusion Criteria: * Age 18 years or older * Patients who are candidates for Roux-en-Y gastric bypass using a minimally invasive technique * Informed consent has been given. Exclusion Criteria: * patients who are candidates for bariatric procedures other than Roux-en-Y gastric bypass, or to those who require a laparotomy for Roux-en-Y gastric bypass surgery.
| Facility | City | Country | Status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma | Italy |