Comparison of the Occurrence of Postoperative Complications Between Robotic and Laparoscopic Surgery in Revision Bariatric Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Obesity and Overweight, Bariatric Surgery. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed 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.
Primary outcome measures
- Postoperative complication rate [Time frame: 12 month]
Secondary outcome measures (4)
- Post-operative PAIN [Time frame: Day 2]
- The total duration of the surgical procedure [Time frame: Day 2]
- Weight loss [Time frame: 12 month]
- Evolution of comorbidities [Time frame: 12 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Hôpital Privé Jean Mermoz — Lyon
- Hôpital privé de la Loire - Ramsay Santé — Saint-Etienne
Identifiers
NCT: NCT07180316 · 2023-06-033-ERAME0598