Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus
| Status: | Archived |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | March 2010 |
| End Date: | June 2011 |
This study is being done to see if a new approach to repair perforated ulcers in the stomach
(holes in the stomach) or the first part of the intestine will work as well or better than
the current methods. Traditionally, either open operations (large single incision) or
laparoscopic operations (multiple small camera-guided incisions) have been used to repair
perforated ulcers. Over the last ten years, some surgeons have used endoscopic equipment to
assist them with performing the procedure. It is unknown if perforated ulcer repair can be
done using an endoscope as the main instrument (a flexible tube with a video camera inserted
into the stomach through your esophagus) to "patch" or plug the perforation. We will patch
the perforation using a standard method which uses tissue from outside the stomach. A
laparoscopic camera will also be used to assist our view. An endoscope may be safer than
open or laparoscopic surgery and lead to less complications but we will not know this until
we do the study. This endoscope is approved by the US Food and Drug Administration (FDA)
and has been used for many years to look inside the stomach; however, we will also use it in
the study procedure to deliver our instruments into and through the hole in your stomach or
first part of your intestine.
Perforation is the most dangerous complication of gastroduodenal ulcer disease. It accounts
for more than 70% of deaths associated with peptic ulcer disease. In addition to age and
concomitant disease, intervention related complications are statistically significant
predictors of death after hospital stay. Age, time to presentation and comorbidities are not
factors that can be influenced. If it would be possible to reduce the impact of procedure
related complications or the "second hit", that may lead to decreased morbidity and
mortality.
We propose to prospectively study the feasibility of an endoscopic transluminal omental
patch closure in patients with perforated viscus. Endoscopy has been used as an adjunct for
laparoscopic omentoplasty in perforated ulcers in the past and endoscopic omental patch
closure of iatrogenic perforations has been reported. An endoscopic approach would also
allow H.pylori or cancer diagnosis and for gastric outlet/duodenal lumen observation before
and after patch placement. In addition, over time it may be possible to perform this
procedure without general anesthesia; thus, leading to decreased invasiveness and possibly
decrease mortality. The feasibility of this endoscopic approach should be studied under
laparoscopic guidance and under circumstances in which a traditional open or laparoscopic
approach could be easily instituted.
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