Benefit of Single Port-surgery in Sleeve Gastrectomy

NCT ID: NCT02360176

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-04
• Study Completion Date: 2022-01-31

Brief Summary

Demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the reference method in terms of complications using a score of morbidity and mortality at 6 and 24 months: Rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis, splenic lesions, hernia, residual gastric pouch and mortality

Detailed Description

The single port surgery is the natural evolution of laparoscopy. To date only few studies have evaluated the feasibility of this technique in sleeve gastrectomy. The investigators want to demonstrate the non-inferiority in terms of morbidity-mortality of use single trocar in sleeve gastrectomy compared the multiport technique. Moreover it should highlight the non-inferiority in terms of anatomical quality, reduction of excess weight lost, reduction of comorbidities, decrease post operative pain, improved quality of life and evaluate medico-economic impact of these technique to validating this new surgical approach for bariatric surgery. The study will be multicentric with 6 university center (Montpellier, Amiens, Lille, Creteil, Poissy and Montsouris Institut). 388 patients will be included in the tow group of the prospective randomise study.

Conditions

Surgical Treatment of Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleeve gastrectomy single port

Sleeve gastrectomy single port

Group Type: EXPERIMENTAL

Sleeve gastrectomy single port

Intervention Type: PROCEDURE

Bariatric surgery: one incision of 2.5 to 3 cm

Sleeve gastrectomy multi trocar

Sleeve gastrectomy multi trocar

Group Type: ACTIVE_COMPARATOR

Sleeve gastrectomy multi trocar

Intervention Type: PROCEDURE

Bariatric surgery: 4 to 7 incisions of 1 to 2 cm

Interventions

Sleeve gastrectomy single port

Bariatric surgery: one incision of 2.5 to 3 cm

Intervention Type: PROCEDURE

Sleeve gastrectomy multi trocar

Bariatric surgery: 4 to 7 incisions of 1 to 2 cm

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• BMI> 35 kg/m2 with comorbidity (s) or> 40 kg/m2
• Patients aged 18 to 65 years
• Discussion and decision sleeve gastrectomy multidisciplinary meeting
• Free, informed and written consent
• Affiliation to a social security or other assurance

Exclusion Criteria

• Uncontrolled severe infection
• Liver disease other than obesity pathology
• Pregnancy (positive hCG)
• Large hiatal hernia
• Esophagitis uncontrolled
• History of gastric bypass and gastric surgery other than gastric banding
• Saving Justice guardianship
• Participation in another ongoing study
• Cognitive or severe mental illness
• Severe and non-stabilized eating disorders
• Addiction to alcohol and psychoactive substances"

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Pourcher, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Montsouris Institut

Locations

Montsouris Insitut

Paris, , France

Countries

France

Other Identifiers

P130940

Identifier Type: -

Identifier Source: org_study_id