Obesity and OverweightROLAPNCT07180316
Comparison of the Occurrence of Postoperative Complications Between Robotic and Laparoscopic Surgery in Revision Bariatric Surgery
An observational study of Obesity and Overweight and Bariatric Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity and Overweight, Bariatric Surgery
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Jun 2025to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing revision bariatric surgery with conversion to RYGB
Who may be able to join
- 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)
Who cannot join
- Pregnant patient
- Patient unable to understand information: dementia, psychosis, impaired consciousness, language difficulties
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Privé Jean Mermoz
Lyon
Aminah Dr EL BOUYOUSFI, 04 28 63 69 69 ext. +33, dr.elbouyousfi@centrechirurgical.fr
- Not yet recruiting
Hôpital privé de la Loire - Ramsay Santé
Saint-Etienne, 42100
Alexandre Dr Filippello, 04 77 42 27 00 ext. +33, alexandre.filippello@orange.fr
About this study
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
Read the 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.
- Conditions
- Obesity and Overweight, Bariatric Surgery
- Keywords
- bariatric revision surgery., Laparoscopy, Robotic surgery
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LAPAROSCOPY SURGERY | Not described | |
| ROBOTIC SURGERY | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month
Secondary outcomes (4)
Post-operative PAIN
Post-operative pain will be assessed by a simple numerical scale rated from 0 (no pain) to 10 (worst pain ever experienced).
Measured: Day 2
The total duration of the surgical procedure
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.
Measured: Day 2
Weight loss
BMI will be collected during follow-up, and weight loss will be compared between the two groups.
Measured: 12 month
Evolution of comorbidities
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)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start17 Jun 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180316
- Sponsor's protocol ID
- 2023-06-033-ERAME0598
- Acronym
- ROLAP
- Status last verified
- Sep 2025
- First submitted
- 24 Jun 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Occurrence of Postoperative Complications Between Robotic and Laparoscopic Surgery in Revision Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07180316
- Acronym / sponsor ID
- ROLAP / 2023-06-033-ERAME0598
- Conditions
- Obesity and Overweight, Bariatric Surgery
- Keywords
- bariatric revision surgery., Laparoscopy, Robotic surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAPAROSCOPY SURGERY | – | – |
| ROBOTIC SURGERY | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing revision bariatric surgery with conversion to RYGB
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Pregnant patient
- Patient unable to understand information: dementia, psychosis, impaired consciousness, language difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hôpital privé de la Loire - Ramsay Santé
Saint-Etienne, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight and Bariatric Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complication rate (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.