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Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

NCT00876551 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-05-26

No results posted yet for this study

Summary

The purpose of this study is to determine the short and long term outcome of endoscopic vacuum assisted closure of intrathoracic postsurgical leaks.

Conditions

  • Mediastinitis
  • Esophageal Neoplasms
  • Anastomotic Leakage

Interventions

PROCEDURE

Endoscopic vacuum assisted closure

1. Endoscopic debridement of wound using a regular biopsy forceps. 2. Introduction via the nose and oral exteriorization of a silicone duodenal tube (Freka Tube, 15 Ch, Fresenius Kabi, Bad Homburg v.d. H. Germany) 3. Fixation of a polyurethane foam (sponge, pore size 400-600 µm, KCI, Wiesbaden Germany) to the tip of the duodenal tube with a mersilene suture (0,35mm, Johnson \& Johnson, St-Stevens-Woluwe, Belgium). 4. Trimming of the sponge to the specific wound size. 5. Endoscopic placement of the sponge in the intrathoracic leak with a grasping forceps (Olympus, Germany) 6. Application of continuous suction of 125mmHg using vacuum pump (KCI, Wiesbaden Germany). 7. Sponge exchange twice a week until wound grounds are clean and closed

Sponsors & Collaborators

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Jochen Wedemeyer, MD · Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00876551 on ClinicalTrials.gov