NCT05189574

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

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

January 3, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

December 19, 2021

Last Update Submit

January 8, 2022

Conditions

Anastomotic Leak

Keywords

staple line leakendoscopic vacuum therapyendoscopic negative pressure therapylaparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

  • Number of patients with closure of staple line leak

    Resolution of the fistula with no further need for intervention (surgical or endoscopic).

    up to 16 weeks

Secondary Outcomes (3)

  • Number of endoscopic interventions

    up to 16 weeks

  • Hospital stay

    up to 24 weeks

  • Mortality

    up to 24 weeks

Interventions

Endoscopic negative pressure therapyPROCEDURE

Endoscopic placement of a sponge in/at staple line leaks under negative pressure.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients older 18 years who underwent laparoscopic sleeve gastrectomy for morbid obesity and developed a proximal staple line leak within 30 days.

You may qualify if:

  • Staple line leak detected by endoscopy and/or CT within 30 days after surgery.
  • Age 18 years or older.
  • Written informed consent.

You may not qualify if:

  • Declined informed consent.
  • Leaks detected later than 30 days after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Vest GmbH

Recklinghausen, North Rhine-Westphalia, 45657, Germany

Location

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Markus Reiser, MD

    Chief Dept. Medicine and Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Dept. Gastroenterology

Study Record Dates

First Submitted

December 19, 2021

First Posted

January 12, 2022

Study Start

January 3, 2020

Primary Completion

June 30, 2021

Study Completion

December 17, 2021

Last Updated

January 12, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)