Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks (EVACoIL)
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|ClinicalTrials.gov Identifier: NCT00876551|
Recruitment Status : Unknown
Verified April 2009 by Hannover Medical School.
Recruitment status was: Recruiting
First Posted : April 6, 2009
Last Update Posted : May 26, 2010
|Condition or disease||Intervention/treatment||Phase|
|Mediastinitis Esophageal Neoplasms Anastomotic Leakage||Procedure: Endoscopic vacuum assisted closure||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Patients that are treated with E-V.A.C.
Procedure: Endoscopic vacuum assisted closure
- Closure of postsurgical leak [ Time Frame: 6 weeks ]
- Short term complications [ Time Frame: 6 weeks ]
- Long term complications [ Time Frame: 6 months ]
- number of endoscopic interventions [ Time Frame: 6 weeks ]
- time to leak closure [ Time Frame: 6 weeks ]
- C reactive protein [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876551
|Contact: Jochen Wedemeyer, MD||+49 511 532 ext email@example.com|
|Contact: Andrea S Schneider, MD||+49 511 532 ext firstname.lastname@example.org|
|Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover||Recruiting|
|Hannover, Germany, 30625|
|Contact: Jochen Wedemeyer, MD +49 511 532 ext 2406 email@example.com|
|Principal Investigator:||Jochen Wedemeyer, MD||Dept. of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover|