Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

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.

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Key information

Conditions

Bariatric Surgery (Sleeve Gastrectomy )

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CLIP OST

Device

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

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jan 31, 2011
Registry last updated: Aug 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed