NCT01286714

Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bariatric Surgery (Sleeve Gastrectomy )

Interventions

Type	Name	Description
DEVICE	CLIP OST

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-01-31
• Last updated: 2014-08-29

Locations

1 site across 1 country: France