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

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Obesity and Overweight; Bariatric Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT07180316

2023-06-033-ERAME0598

Details and patient eligibility

About

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

Full description

The study procedures are the usual procedures of investigators who usually perform bariatric revision surgery. There is no change from the usual care. Participation in the study does not alter the benefit/risk ratio of the surgical procedure, does not alter the usual follow-up of patients who have undergone this type of surgery, and does not collect data other than those usually collected as part of follow-up.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

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

Trial design

200 participants in 2 patient groups

LAPAROSCOPY SURGERY

ROBOTIC SURGERY