Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus (NCT01080326) | Clinical Trial Compass
CompletedNot Applicable
Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus
United States7 participantsStarted 2010-03
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \> 21
* 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 \<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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair