Bariatric Surgery (Sleeve Gastrectomy )
Conditions
Brief 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.
Interventions
DEVICECLIP OST
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacity of closure of fistulas by clips ovesco | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| The efficacity of the suture in 3 months of these complex refractory fistulas | 12 months |
Countries
France
Outcome results
None listed