Benefit of Single Port-surgery in Sleeve Gastrectomy

Surgical Treatment of Obesity Clinical Trial

— MINIOB  

Official title:

Evaluation of Minimally Invasive Bariatric Surgery Using a Single Laparoscopic Trocar (Single Incision of 2.5 to 3 cm) Versus 4 to 7 Trocars in Sleeve Gastrectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02360176
• Other study ID #: P130940
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2017
• Est. completion date: January 2022

Study information

• Verified date: September 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 332
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 - Anesthetics

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"

Related Conditions & MeSH terms

• Surgical Treatment of Obesity

Intervention

Procedure:
• Sleeve gastrectomy single port
Bariatric surgery: one incision of 2.5 to 3 cm
• Sleeve gastrectomy multi trocar
Bariatric surgery: 4 to 7 incisions of 1 to 2 cm

Locations

Country	Name	City	State
France	Montsouris Insitut	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	The principal criteria of analysis will be a score of morbidity and mortality at 24 months including: rate of fistula and intra-abdominal abscesses, the bleeding rate, the rate of gastric stenosis, rate splenic lesions, residual pouch or parietal damage (abscesses, incisional hernia, hematoma, delayed wound healing), and death	up to 24 months
Secondary	Complication rate		up 3, 6, 9, and 12 months
Secondary	Reduction of excess weight by measuring BMI in kg / m2 pre-and postoperatively		up 3, 6, 12 and 24 months