N/A
N=7
Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus
Peptic Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT01080326 ↗Enrolled (actual)
7
Serious AEs
33.3%
Results posted
Apr 2015
Primary outcome: Primary: Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair — 2; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endoscopic Translumenal Omental Patch (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair |
2; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01080326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.