NCT00876551

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 26, 2010

Status Verified

April 1, 2009

Enrollment Period

4.9 years

First QC Date

April 3, 2009

Last Update Submit

May 25, 2010

Conditions

MediastinitisEsophageal NeoplasmsAnastomotic Leakage

Keywords

Negative-Pressure Wound TherapyEndoscopic/endoluminal V.A.C. therapyEsophagectomyAnastomotic leakageAnastomosis, Surgical

Outcome Measures

Primary Outcomes (1)

  • Closure of postsurgical leak

    6 weeks

Secondary Outcomes (5)

  • 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

Study Arms (1)

E-V.A.C.

EXPERIMENTAL

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

Procedure: Endoscopic vacuum assisted closure

Interventions

Endoscopic vacuum assisted closurePROCEDURE

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

Also known as: Endoluminal vacuum assisted closure, E-V.A.C., Endosponnge
E-V.A.C.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover

Hanover, 30625, Germany

RECRUITING

Related Publications (2)

  • Wedemeyer J, Schneider A, Manns MP, Jackobs S. Endoscopic vacuum-assisted closure of upper intestinal anastomotic leaks. Gastrointest Endosc. 2008 Apr;67(4):708-11. doi: 10.1016/j.gie.2007.10.064.

    PMID: 18374029BACKGROUND

  • Wedemeyer J, Brangewitz M, Kubicka S, Jackobs S, Winkler M, Neipp M, Klempnauer J, Manns MP, Schneider AS. Management of major postsurgical gastroesophageal intrathoracic leaks with an endoscopic vacuum-assisted closure system. Gastrointest Endosc. 2010 Feb;71(2):382-6. doi: 10.1016/j.gie.2009.07.011. Epub 2009 Oct 30.

    PMID: 19879566DERIVED

MeSH Terms

Conditions

MediastinitisEsophageal NeoplasmsAnastomotic Leak

Condition Hierarchy (Ancestors)

Mediastinal DiseasesThoracic DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jochen Wedemeyer, MD

    Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jochen Wedemeyer, MD

CONTACT

+49 511 532wedemeyer.jochen@mh-hannover.de

Andrea S Schneider, MD

CONTACT

+49 511 532andrea.s.schneider@gmx.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 6, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 26, 2010

Record last verified: 2009-04

Locations

DE(1)