Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass
LvRRYGB
1 other identifier
interventional
512
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2023
CompletedFirst Posted
Study publicly available on registry
September 4, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
September 4, 2025
September 1, 2024
2.5 years
August 28, 2023
August 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Early complications rate
The percentage or proportion of individuals who experience adverse events or negative outcomes within a 30th day of time after hospital discharge
30 Days after hospital discharge
Secondary Outcomes (6)
Intraoperative complications rate
From the beginning to the end of the surgical procedure
Conversions rate
From the beginning to the end of the surgical procedure
mortality rate
30 days after hospital discharge
Operative time
From the beginning to the end of the surgical procedure
Length of hospital stay
up to 1 week
- +1 more secondary outcomes
Study Arms (2)
Laparoscopic RYGB
ACTIVE COMPARATORPatients undergoing Roux-en-Y gastric bypass (RYGB) surgery performed laparoscopically.
Robotic RYGB
EXPERIMENTALPatients undergoing Roux-en-Y gastric bypass (RYGB) surgery performed using the DaVinci robotic platform.
Interventions
Laparoscopic and robotic (DaVinci) Roux-en-Y Gastric Bypass
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Raffaelli
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Central Study Contacts
Marco Raffaelli, Prof.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2023
First Posted
September 4, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
September 4, 2025
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share