Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus
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 the subject's stomach or the first part of the subject's intestine.
Hypothesis: Endoscopic translumenal omental patch closure will be successful in > 80% of patients with perforated peptic ulcer as evidenced by intra-operative leak test and postoperative gastrografin swallow.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus|
- Successful completion of the procedure. At the time of surgery the repair will be pressure tested using endoscopic insufflation. Post-op all patients will undergo Gastrografin swallow to evaluate for leak. [ Time Frame: Leak Evaluation during surgery and 2 days post-op ] [ Designated as safety issue: Yes ]
- Secondary outcome data such as pain score and quality of life, heart rate variability analysis will be collected to establish pilot data for possible future trials if feasibility is established. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Endoscopic Translumenal Omental Patch
Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.
Device: Endoscopic Translumenal Omental Patch
The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place.
Other Name: Ulcer repair surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080326
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Juliane Bingener-Casey, MD.S||Mayo Clinic|