Transluminal or Percutaneous Endoscopic Drainage and Debridement of Abcesses After Bariatric Surgery
October 16, 2014 updated by: Erasme University Hospital
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.
Study Overview
Detailed Description
This retrospective study in an academic tertiary center will review the files of patients who underwent endoscopic drainage and debridement of abdominal abscesses secondary to bariatric surgery leaks . The decision for endoscopic treatment was made by the medico-surgical team in charge of this type of surgery, who had to weigh the high risk of mortality in case of re-intervention, along with endoscopic access to abscesses via the transluminal or percutaneous route based on abdominal imaging.
Data collection will lead to the evaluation of the technical success rate, the clinical success and potential complications.
Study Type
Observational
Enrollment (Actual)
9
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- All other necrosectomies performed for pancreatic disorders were excluded from the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention technical success
Time Frame: during the procedure
|
success to pass the scope and perform abcess debridement of the targeted collection
|
during the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical success
Time Frame: 7 days
|
success to control sepsis after endoscopic drainage
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jacques Devière, MD, PhD, Erasme Hospital, ULB
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
October 8, 2014
First Submitted That Met QC Criteria
October 16, 2014
First Posted (Estimate)
October 17, 2014
Study Record Updates
Last Update Posted (Estimate)
October 17, 2014
Last Update Submitted That Met QC Criteria
October 16, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bariatric endoscopic drainage
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