NCT01286714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

2.7 years

First QC Date

January 28, 2011

Last Update Submit

August 28, 2014

Conditions

Bariatric Surgery (Sleeve Gastrectomy )

Outcome Measures

Primary Outcomes (1)

  • The efficacity of closure of fistulas by clips ovesco

    12 months

Secondary Outcomes (1)

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

    12 months

Study Arms (1)

clips OST

EXPERIMENTAL
Device: CLIP OST

Interventions

CLIP OSTDEVICE
clips OST

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Officials

  • BERNARD BELAIGUES

    Assistance Publique hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2011

First Posted

January 31, 2011

Study Start

January 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

August 29, 2014

Record last verified: 2014-08

Locations

FR(1)