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Trial Title:
Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
NCT ID:
NCT00876551
Condition:
Mediastinitis
Esophageal Neoplasms
Anastomotic Leakage
Conditions: Official terms:
Esophageal Neoplasms
Mediastinitis
Anastomotic Leak
Conditions: Keywords:
Negative-Pressure Wound Therapy
Endoscopic/endoluminal V.A.C. therapy
Esophagectomy
Anastomotic leakage
Anastomosis, Surgical
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Endoscopic vacuum assisted closure
Description:
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
Arm group label:
E-V.A.C.
Other name:
Endoluminal vacuum assisted closure
Other name:
E-V.A.C.
Other name:
Endosponnge
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jochen Wedemeyer, MD
Phone:
+49 511 532
Phone ext:
2406
Email:
wedemeyer.jochen@mh-hannover.de
Start date:
January 2008
Completion date:
December 2012
Lead sponsor:
Agency:
Hannover Medical School
Agency class:
Other
Source:
Hannover Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00876551
