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

Status

Completed

Conditions

Intervention / Treatment

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.
Procedure: endoscopic drainage
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

Erasme University Hospital

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Clinical Trials on endoscopic drainage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe