Actively Recruiting
Comparison of the Occurrence of Postoperative Complications Between Robotic and Laparoscopic Surgery in Revision Bariatric Surgery
Led by GCS Ramsay Santé pour l'Enseignement et la Recherche · Updated on 2025-09-18
200
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two surgical methods—robotic surgery and laparoscopy—in patients undergoing bariatric revision surgery with conversion to Roux-en-Y gastric bypass (RYGB). The main goal is to evaluate and compare the rates of complications after surgery between these two groups. Secondary goals include comparing surgery duration, emergency room and hospital stays, postoperative pain, adverse events, weight loss, and improvements in related health conditions over time. The study follows standard surgical procedures without altering usual care or follow-up protocols. Participants are divided into two groups based on the type of surgery they receive: robotic or laparoscopic. The surgical care and data collection remain consistent with routine practices, ensuring that participation does not change the usual benefit or risk balance of the surgery. Participants will be monitored during their usual follow-up visits, with data collected on complications within 12 months after surgery. Researchers will assess postoperative pain two days after surgery, track the length of the surgical procedure, and evaluate weight loss and changes in comorbidities up to one year. The study does not require additional procedures beyond standard care and aims to provide detailed insights into the outcomes of these surgical approaches.
CONDITIONS
Brief Title
Comparison of the Occurrence of Postoperative Complications Between Robotic and Laparoscopic Surgery in Revision Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 70 years
- Patients who have been informed of the study objectives and conditions and have not objected to data collection
- Patients who are candidates for or have undergone revision bariatric surgery with conversion to Roux-en-Y gastric bypass (post-ring, post-sleeve, post-OAGB)
You will not qualify if you...
- Pregnant patients
- Patients unable to understand study information due to dementia, psychosis, impaired consciousness, or language difficulties
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 days
Participants undergo revision bariatric surgery using either robotic or laparoscopic methods and receive usual immediate post-operative care.
1 surgical procedure and hospital stay
Duration - Up to 12 months
Participants receive routine follow-up care with assessments for complications, pain, weight loss, and evolution of comorbidities as normally performed after bariatric surgery.
Regular follow-up visits as per usual care
Trial Site Locations
Total: 2 locations
1
Hôpital Privé Jean Mermoz
Lyon, France
Actively Recruiting
2
Hôpital privé de la Loire - Ramsay Santé
Saint-Etienne, France, 42100
Not Yet Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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