A prospective feasibility study on the treatment of gastrointestinal leakage by the use of combination of covered nitinol stent and negative pressure wound treatment

Not Applicable

Recruiting

• Conditions: K22.3; K63.1; Perforation of oesophagus; Perforation of intestine (nontraumatic)

• Registration Number: DRKS00016048
• Lead Sponsor: Klinik für Viszeral-, Tumor-, Transplantations- und Gefäßchirurgie, Klinikum Köln-Merheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Presence of a written consent of the patient
• Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus
• Accessibility of the leakage with the delivery system of the VAC stent

Exclusion Criteria

• Simultaneous participation in other interventional trials
• Endoscopic inaccessibility of the affected section
• Full anticoagulation with INR > 1.5 and/or PTT > 50 sec, or platelets < 20.000/µl (after therapeutic correction an inclusion is possible)
• Unstable patients with a severe septic condition who require an immediate operation
• ileus image with constant vomiting (after gastric tube and gastric emptyingan inclusion is possible)
• Persons who are in a dependency / employment relationship with the sponsor or investigator
• Accommodation in an institution under court or administrative order

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to evaluate the suitability of the medical device for sealing leaks in the esophagus or colon. The technical application is checked every time the stent is changed, measured by whether the stent can be successfully implanted and seals the leakage.

Secondary Outcome Measures

Name	Time	Method
• Prevention/elemination of sepsis<br>• Morphological healing of insufficiency<br>• detection of complications (stent dislocation, erosion of tissue structures in the abscess cavity / in the esophagus or colon / bleeding)