Comparison of the Occurrence of Postoperative Complications Between Robotic and Laparoscopic Surgery in Revision Bariatric Surgery

NCT07180316 | Recruiting

• 1 other identifier: 2023-06-033-ERAME0598
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

In a population of patients undergoing bariatric revision surgery with conversion to RYGB and divided into two groups according to the surgical protocol: Group 1: robotic surgery Group 2: laparoscopy The primary objective of the study is to compare the rates of postoperative complications between the two groups, classified according to the Clavien Dindo classification. The secondary objectives are to compare between the groups:

• Total duration of the surgical procedure, stay in the emergency room, and hospitalization
• Postoperative pain
• Adverse events
• Weight loss
• Improvement in comorbidities

Conditions

Obesity and Overweight; Bariatric Surgery

Keywords

bariatric revision surgery.; Laparoscopy; Robotic surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative complication rate

  The complications routinely screened for are: gastrointestinal fistulas (gastrojejunal anastomosis fistula, excluded gastric fistula, and loop foot fistula), bruit, anastomotic stenosis, anastomotic ulcer, splenic infarction, the development of a deep abdominal collection, and pulmonary and cardioembolic complications. The diagnosis of gastrointestinal fistula will be made in the event of signs of sepsis associated with the presence of an intra-abdominal collection on CT scan, the need for intravenous antibiotics with strict fasting and exclusive parenteral nutrition, and/or the need for surgical exploration. Depression is defined as the postoperative need for blood transfusion, with a drop in hemoglobin levels of at least 2.5 g/dL compared to the preoperative level. Postoperative complications will be obtained according to the Clavien Dindo classification

  12 month

Secondary Outcomes (4)

• Post-operative PAIN

  Day 2

• The total duration of the surgical procedure

  Day 2

• Weight loss

  12 month

• Evolution of comorbidities

  12 month

Study Arms (2)

LAPAROSCOPY SURGERY

ROBOTIC SURGERY

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing revision bariatric surgery with conversion to RYGB

You may qualify if:

• Patients aged 18 to 70 years,
• Patients who have been informed of the objectives and conditions of the study and who have not objected to the collection of their data
• Patients who are candidates for or have undergone revision bariatric surgery with conversion to RYGB (post-ring, post-sleeve, post-OAGB)

You may not qualify if:

• Pregnant patient
• Patient unable to understand information: dementia, psychosis, impaired consciousness, language difficulties

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (2)

Hôpital Privé Jean Mermoz

Lyon, France

RECRUITING

Hôpital privé de la Loire - Ramsay Santé

Saint-Etienne, 42100, France

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: September 18, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)