Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

Assistance Publique Hopitaux De Marseille15 enrolled

Overview

Anastomotic fistula following bariatric surgery are lifethreatening complication with a 37.5% mortality rate. All the modalities for bariatric surgery are involved in this type of complication, but Sleeve gastrectomy is the main surgery responsible for the frequency and the severity of the fistula. The management of this complication is still controversial and potentially lethal. The average number of endoscopic sessions was 4 (range 2-11). The closure could be obtained within a mean time of 88 days (range 6-216 days). Therefore endoscopic management has to be improved to reduce the duration of the treatment and the number of endoscopic sessions. OTSC clips could help to improve the endoscopic management because of a more prehensive, deeper and larger suture area.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bariatric Surgery (Sleeve Gastrectomy )

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age upper to 18 years * surgery bariatrique typical Sleeve * presence of one or two fistulas \< 1 cm, beforehand drained and without sepsis evolutionary * signature of the consent Exclusion Criteria: * surgery bariatrique other one than Sleeve * refusal of the patient of this endoscopic repeated coverage(care) requiring several sessions of endoscopies under AG with hospitalizations * Current Sepsis * not drained cavity * Absence of signed consent

Outcomes

Primary Outcomes

The efficacity of closure of fistulas by clips ovesco

Time frame: 12 months

Secondary Outcomes

The efficacity of the suture in 3 months of these complex refractory fistulas