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.
Inclusion Criteria:
- Patients presenting with clinical diagnosis of a perforated viscus who are scheduled to undergo surgical intervention
- Surgical candidate for endoscopic, laparoscopic, or open procedure
- Age > 18
- Informed written consent
Exclusion Criteria:
- Prior gastric or duodenal surgery
- Prior total abdominal colectomy or transverse colectomy
- Prior omentectomy or omental flaps
- Known perforation site other than stomach or duodenum
- Patients with contra-indications for laparoscopy
- Patients with contraindications for endoscopy
- Upper gastrointestinal anatomy that would preclude endoscopic therapy
- Coagulopathy or thrombocytopenia
- Pregnant patients
- Patients <18 years of age
- Prisoners
- Patients found at surgery to have disease processes other than perforated peptic ulcer disease will be asked for permission to record their data for comparison
Last updated: 01/15/2013
NCT ID: NCT01080326
IRB Number:08-008389
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