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

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

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Key information

Conditions

Obesity and Overweight Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Privé Jean Mermoz, Lyon, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Postoperative complication rate

Time frame: 12 month

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

Secondary outcomes

Post-operative PAIN

Time frame: Day 2

Post-operative pain will be assessed by a simple numerical scale rated from 0 (no pain) to 10 (worst pain ever experienced).
The total duration of the surgical procedure

Time frame: Day 2

Duration of anesthesia, duration of the surgical procedure,Length of stay in the Post-Anesthesia Care Unit, Time from end of surgery to first mobilization, Time from end of surgery to hospital discharge will be collected and compared between the two groups.
Weight loss

Time frame: 12 month

BMI will be collected during follow-up, and weight loss will be compared between the two groups.
Evolution of comorbidities

Time frame: 12 month
The occurrence, worsening, or resolution of the following comorbidities will be recorded:
- Diabetes: type 1 or type 2
- Arterial hypertension
- Dyslipidemia
- Obstructive sleep apnea syndrome (OSAS) or other severe obesity-related respiratory disorders
- Chronic osteoarticular conditions
- NASH (non-alcoholic steatohepatitis) or other metabolic liver diseases
- Metabolic syndrome (defined as the presence of at least three of the following metabolic abnormalities: increased waist circumference, hyperglycemia, hypertension, hypertriglyceridemia, low HDL cholesterol)
- Nephropathy
- PCOS (Polycystic Ovary Syndrome)

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: ROLAP

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Sep 18, 2025
Registry last updated: Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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