ObesityNCT02266901
Transluminal or Percutaneous Endoscopic Drainage and Debridement of Abcesses After Bariatric Surgery
An observational study of Obesity and Sepsis, run by Erasme University Hospital.
Trial summary
Patients presenting intra-abdominal abcesses following bariatric surgery complicated by fistulae are classically treated by external drainage and endoprosthesis or surgical redo. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- endoscopic drainage
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- All other necrosectomies performed for pancreatic disorders were excluded from the study
About this study
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.
Read the 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.
- Being tested
- endoscopic drainage
- Keywords
- leaks after bariatric surgery, fistulae after bariatric surgery, abdominal abcesses and bariatric surgery, endoscopic drainage of abcesses, percutaneous drainage of abcesses, gastric bypass, sleeve gastrectomy, necrotic collection and bariatric surgery
- Medical subject headings
- Obesity, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic drainageProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: endoscopic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention technical success
success to pass the scope and perform abcess debridement of the targeted collection
Measured: during the procedure
Secondary outcomes (1)
Clinical success
success to control sepsis after endoscopic drainage
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2007
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Devière, MD, PhD, Study director, Erasme Hospital, ULB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266901
- Sponsor's protocol ID
- Bariatric endoscopic drainage
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2014
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transluminal or Percutaneous Endoscopic Drainage and Debridement of Abcesses After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02266901
- Acronym / sponsor ID
- Bariatric endoscopic drainage
- Keywords
- leaks after bariatric surgery, fistulae after bariatric surgery, abdominal abcesses and bariatric surgery, endoscopic drainage of abcesses, percutaneous drainage of abcesses, gastric bypass, sleeve gastrectomy, necrotic collection and bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases (endoscopic drainage) | – | Procedure: endoscopic drainageSeptic 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- All other necrosectomies performed for pancreatic disorders were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic drainageEndoscopic 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. | Procedure or surgery | Cases (endoscopic drainage) |
Primary outcome
Intervention technical success
Time frame: during the procedure
success to pass the scope and perform abcess debridement of the targeted collection
1 secondary outcome
Clinical success
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Devière, MD, PhD study director
Erasme Hospital, ULB
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Sepsis, run by Erasme University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention technical success (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.