An interventional study of Endoscopic vacuum assisted closure in Mediastinitis, Esophageal Neoplasms and Anastomotic Leakage, sponsored by Hannover Medical School. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-05-26.
Sponsored by Hannover Medical School · Not applicable, Interventional, and Treatment
The purpose of this study is to determine the short and long term outcome of endoscopic vacuum assisted closure of intrathoracic postsurgical leaks.
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.
21 studies on the registry are indexed under Mediastinitis; 3 are open to participants now.
This study's planned enrollment of 30 is below the median of 83 across 12 interventional studies indexed under Mediastinitis.
Browse Mediastinitis studies →Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients that are treated with E-V.A.C.
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
Also known as: Endoluminal vacuum assisted closure, E-V.A.C., Endosponnge
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
The record gives a start of Jan 2008, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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