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

NCT ID: NCT07180316

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-17

Study Completion Date

2029-06-30

Brief Summary

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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

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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

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Obesity and Overweight Bariatric Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LAPAROSCOPY SURGERY

No interventions assigned to this group

ROBOTIC SURGERY

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Privé Jean Mermoz

Lyon, , France

Site Status RECRUITING

Hôpital privé de la Loire - Ramsay Santé

Saint-Etienne, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Facility Contacts

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Aminah Dr EL BOUYOUSFI

Role: primary

04 28 63 69 69 ext. +33

Alexandre Dr Filippello

Role: primary

04 77 42 27 00 ext. +33

Other Identifiers

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2023-06-033-ERAME0598

Identifier Type: -

Identifier Source: org_study_id

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