Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Bariatric Surgery (Sleeve Gastrectomy )

Treatments: Device: CLIP OST

Study type: Interventional

Funder types: Other

Identifiers

NCT01286714

2010-A01210-39

2010-21 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

clips OST

Experimental group

Treatment:

Device: CLIP OST