Anastomotic LeakNCT05189574
Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks
An observational study of Anastomotic Leak, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Endoscopic negative pressure therapy (ENPT) is a safe technique, showing promising results in the treatment of leakages of the upper and lower gastrointestinal tract. The purpose of this study is to determine the safety and efficacy of ENPT in the management of proximal staple line leak after sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anastomotic Leak
- What is being tested?
- Endoscopic negative pressure therapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jan 2020to 17 Dec 2021
- 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 70 years
- All sexes
- Adult, Older adult
Study population: Patients older 18 years who underwent laparoscopic sleeve gastrectomy for morbid obesity and developed a proximal staple line leak within 30 days.
Who may be able to join
- Staple line leak detected by endoscopy and/or CT within 30 days after surgery.
- Age 18 years or older.
- Written informed consent.
Who cannot join
- Declined informed consent.
- Leaks detected later than 30 days after surgery.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Vest GmbH
Recklinghausen, North Rhine-Westphalia, 45657
About this study
Official title: Endoscopic Negative Pressure Therapy for Post-sleeve Gastrectomy Proximal Staple Line Leaks
Endoscopic negative pressure therapy (ENPT) is a safe technique, showing promising results in the treatment of leakages of the upper and lower gastrointestinal tract. The purpose of this study is to determine the safety and efficacy of ENPT in the management of proximal staple line leak after sleeve gastrectomy.
Read the detailed description
Clinical data of 40 cases of post-SG proximal staple line leak treated with ENPT are analysed. Success is defined as resolution of the fistula with no further need for intervention (surgical or endoscopic).
- Conditions
- Anastomotic Leak
- Being tested
- Endoscopic negative pressure therapy
- Keywords
- staple line leak, endoscopic vacuum therapy, endoscopic negative pressure therapy, laparoscopic sleeve gastrectomy
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic negative pressure therapyProcedure or surgery
Endoscopic placement of a sponge in/at staple line leaks under negative pressure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with closure of staple line leak
Resolution of the fistula with no further need for intervention (surgical or endoscopic).
Measured: up to 16 weeks
Secondary outcomes (3)
Number of endoscopic interventions
Number of endoscopic interventions in each patient
Measured: up to 16 weeks
Hospital stay
Time of hospital stay for each patient
Measured: up to 24 weeks
Mortality
Mortality rate during hospital stay
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start3 Jan 2020
- Primary completion30 Jun 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Reiser, M.D., Ruhr University of Bochum
- Investigators
- Markus Reiser, MD, Principal investigator, Chief Dept. Medicine and Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189574
- Sponsor's protocol ID
- EVac-LSGL
- Status last verified
- Jan 2022
- First submitted
- 19 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Negative Pressure Therapy for Post-sleeve Gastrectomy Proximal Staple Line Leaks
- ClinicalTrials.gov ID
- NCT05189574
- Acronym / sponsor ID
- EVac-LSGL
- Conditions
- Anastomotic Leak
- Keywords
- staple line leak, endoscopic vacuum therapy, endoscopic negative pressure therapy, laparoscopic sleeve gastrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 12 Jan 2022 (actual)
- 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.
Endoscopic negative pressure therapy (ENPT) is a safe technique, showing promising results in the treatment of leakages of the upper and lower gastrointestinal tract. The purpose of this study is to determine the safety and efficacy of ENPT in the management of proximal staple line leak after sleeve gastrectomy.
Detailed description
Clinical data of 40 cases of post-SG proximal staple line leak treated with ENPT are analysed. Success is defined as resolution of the fistula with no further need for intervention (surgical or endoscopic).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients older 18 years who underwent laparoscopic sleeve gastrectomy for morbid obesity and developed a proximal staple line leak within 30 days.
Key inclusion criteria (3 listed)
- Staple line leak detected by endoscopy and/or CT within 30 days after surgery.
- Age 18 years or older.
- Written informed consent.
Key exclusion criteria (2 listed)
- Declined informed consent.
- Leaks detected later than 30 days after surgery.
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 negative pressure therapyEndoscopic placement of a sponge in/at staple line leaks under negative pressure. | Procedure or surgery | – |
Primary outcome
Number of patients with closure of staple line leak
Time frame: up to 16 weeks
Resolution of the fistula with no further need for intervention (surgical or endoscopic).
3 secondary outcomes
Number of endoscopic interventions
Time frame: up to 16 weeks
Hospital stay
Time frame: up to 24 weeks
Mortality
Time frame: up to 24 weeks
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 12 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Markus Reiser, MD principal investigator
Chief Dept. Medicine and Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak, run by Ruhr University of Bochum at 1 site in Germany.
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 3 inclusion and 2 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 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of patients with closure of staple line leak (time frame: up to 16 weeks). 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 12 Jan 2022.