Skip to main content
Clinical Trials/NCT00876551
NCT00876551UnknownNot Applicable

Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

Hannover Medical School1 site in 1 country30 target enrollmentStarted: January 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
1
Primary Endpoint
Closure of postsurgical leak

Study Overview

Brief Summary

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

Detailed Description

Intrathoracic leakage is a serious complication after esophageal surgery. The reported incidence of esophageal anastomotic leaks after gastrectomy and esophagectomy ranges from 5% to almost 30%. Within the last 10 years endoscopic treatment has changed the approach to intrathoracic anastomotic leakages. Application of metal clips, injection of fibrin glue and placement of self expanding metal or plastic stents (SEMS/SEPS) have been reported to successfully achieve closure of postoperative anastomotic leaks in approximately 66-100%. Alternative endoscopically treatment modalities are welcome especially in cases of failure of the above mentioned endoscopic treatment modalities to prevent the necessity of surgical reintervention which is associated with high mortality or mutilating surgical outcome such as proximal diversion with cervical esophagostomy.

Vacuum-assisted closure (V.A.C.) is an established treatment modality for extensive cutaneous infected wounds. The V.A.C. system device is based on a negative pressure applied to the wound via a vacuum sealed sponge tissue. The sponge results in formation of granulation tissue, while the vacuum removes wound secretions and reduces edema and therefore improves blood flow, all together achieving consecutive wound closure. Since its introduction in the late 1990´s the number of indications for the V.A.C. system has steadily increased. Recently the endoluminal application of a vacuum assisted wound closure system for the closure of rectal anastomotic fistulas has been reported. Our group reported the successful closure of intrathoracic anastomotic leaks in two cases by endoscopic placement of a vacuum assisted closure system. Here we plan to study the efficacy, safety and long term outcome of E-V.A.C. to treat major intrathoracic postsurgical leaks.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •All patients at the Medical School Hannover that present with intrathoracic postsurgical leakage that can be intubated with a regular 9.2mm diameter endoscope (Olympus GIF-165, Olympus
  • •Age over 18 years old
  • •Signed informed consent

Exclusion Criteria

  • •Small leakage that can be treated with clips
  • •Refusal to participate in study

Arms & Interventions

E-V.A.C.

Experimental

Patients that are treated with E-V.A.C.

Intervention: Endoscopic vacuum assisted closure (Procedure)

Outcomes

Primary Outcomes

Closure of postsurgical leak

Time Frame: 6 weeks

Secondary Outcomes

  • Short term complications(6 weeks)
  • Long term complications(6 months)
  • number of endoscopic interventions(6 weeks)
  • time to leak closure(6 weeks)
  • C reactive protein(6 weeks)

Investigators

Sponsor Class
Other

Study Sites (1)

Loading locations...

Similar Trials