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Completed

NCT Number: NCT05189574

Endo-Vac-Therapy for Post-Sleeve Gastrectomy 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.

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Key information

Conditions

Anastomotic Leak Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Vest GmbH

Recklinghausen, North Rhine-Westphalia, 45657, Germany

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Endoscopic Negative Pressure Therapy

Procedure

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Number of endoscopic interventions

    Time frame: up to 16 weeks

    Number of endoscopic interventions in each patient

  2. Hospital stay

    Time frame: up to 24 weeks

    Time of hospital stay for each patient

  3. Mortality

    Time frame: up to 24 weeks

    Mortality rate during hospital stay

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

Endoscopic Negative Pressure Therapy for Post-sleeve Gastrectomy Proximal Staple Line Leaks

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2022
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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