NCT02266901

Brief Summary

Patients presenting intra-abdominal abcesses following bariatric surgery complicated by fistulae are classically treated by external drainage and endoprosthesis or surgical redo. Morbidity and mortality being increased in case of necrotic collections, an endoscopic debridement treatment might be proposed in certain cases. This present study aim to review the evolution of the patients treated by this method from 2007 to 2011 in the investigators institution.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
Last Updated

October 17, 2014

Status Verified

October 1, 2014

Enrollment Period

6.9 years

First QC Date

October 8, 2014

Last Update Submit

October 16, 2014

Conditions

Keywords

leaks after bariatric surgeryfistulae after bariatric surgeryabdominal abcesses and bariatric surgeryendoscopic drainage of abcessespercutaneous drainage of abcessesgastric bypasssleeve gastrectomynecrotic collection and bariatric surgery

Outcome Measures

Primary Outcomes (1)

  • Intervention technical success

    success to pass the scope and perform abcess debridement of the targeted collection

    during the procedure

Secondary Outcomes (1)

  • Clinical success

    7 days

Study Arms (1)

Cases (endoscopic drainage)

Septic patients presenting post-bariatric collections related to leaks not adequately drained by percutaneous drain, for whom endoscopic drainage of the collections was performed by transluminal or percutaneous route.

Procedure: endoscopic drainage

Interventions

Endoscopic percutaneous access was obtained through surgical drains or after ultrasound-guided percutaneous drainage with a thin scope , and transluminal procedures with large scopes through the leak hole. All the procedures were performed under general anesthesia and carbon dioxide insufflation. Debridement was done by pus aspiration and irrigation.

Cases (endoscopic drainage)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All the patient treated in an academic tertiary center (Erasme Hospital) who underwent endoscopic drainage and debridement of abdominal abscesses secondary to postbariatric surgery leaks from october 2007 to April 2011. All other necrosectomies performed for pancreatic disorders were excluded from the study

You may qualify if:

  • All the patient treated in an academic tertiary center who underwent endoscopic drainage and debridement of abdominal abscesses secondary to bariatric surgery leaks from october 2007 to April 2011
  • septic state

You may not qualify if:

  • All other necrosectomies performed for pancreatic disorders were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesitySepsis

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic Processes

Study Officials

  • Jacques Devière, MD, PhD

    Erasme Hospital, ULB

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2014

First Posted

October 17, 2014

Study Start

October 1, 2007

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 17, 2014

Record last verified: 2014-10