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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.
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Endoscopic Translumenal Omental Patch
Not yet recruiting
Published on BioPortfolio: 2014-07-23T21:09:55-0400
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Bleeding from a PEPTIC ULCER that can be located in any segment of the GASTROINTESTINAL TRACT.
Penetration of a PEPTIC ULCER through the wall of DUODENUM or STOMACH allowing the leakage of luminal contents into the PERITONEAL CAVITY.
Ulcer that occurs in the regions of the GASTROINTESTINAL TRACT which come into contact with GASTRIC JUICE containing PEPSIN and GASTRIC ACID. It occurs when there are defects in the MUCOSA barrier. The common forms of peptic ulcers are associated with HELICOBACTER PYLORI and the consumption of nonsteroidal anti-inflammatory drugs (NSAIDS).
A PEPTIC ULCER located in the DUODENUM.
Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief.
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