Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus
Completed · Not applicable
Conditions studied: Peptic Ulcer
In brief
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 is possible. 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. This study is intended to be a feasibility study to demonstrate the endoscopic technique can be safely performed Hypothesis: The primary outcome is successful completion of the procedure.
Key facts
- Study ID
- NCT01080326
- Run by
- Mayo Clinic
- People needed
- 7
- Starts
- 2010-03-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2015-04-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 > 21
- Informed written consent
You may not qualify if…
- 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 <21 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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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