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Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus - NCT01080326-55905(Clinical Trial 566897)



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City:  Rochester
State:  
MN
Zip Code: 55905
Conditions: Peptic Ulcer
Purpose: 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.
Study summary: 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.
Criteria: Inclusion Criteria 1. Patients presenting with clinical diagnosis of a perforated viscus who are scheduled to undergo surgical intervention 2. Surgical candidate for endoscopic, laparoscopic, or open procedure 3. Age > 18 4. Informed written consent Exclusion Criteria 1. Prior gastric or duodenal surgery 2. Prior total abdominal colectomy or transverse colectomy 3. Prior omentectomy or omental flaps 4. Known perforation site other than stomach or duodenum 5. Patients with contra-indications for laparoscopy 6. Patients with contraindications for endoscopy 7. Upper gastrointestinal anatomy that would preclude endoscopic therapy 8. Coagulopathy or thrombocytopenia 9. Pregnant patients 10. Patients <18 years of age 11. Prisoners 12. 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
Study is available at: Mayo Clinic
Rochester, MN 55905
United States

Primary Contact:
Juliane Bingener-Casey, MD
Email: bingenercasey.juliane@mayo.edu
Phone: 507-293-0767

Secondary Contact:
Juliane Bingener-Casey, MD
Email: bingenercasey.juliane@mayo.edu
Phone: 507-293-0767
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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