Clinical trial NCT01080326: Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus
Official title: Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peptic Ulcer
Keywords: ulcer repair surgery
transluminal omental patch
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Natural Orifice Surgery Consortium for Assessment and Research
First posted: 2010-03-04
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.

Detailed description: 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.

This will be a pilot clinical study to evaluate the safety and feasibility of endoscopic translumenal omental patch closure. Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. Endoscopic translumenal omental patch will be attempted first if the patient has no contraindication. Should this prove unsuccessful, the surgical team will proceed with conversion to laparoscopic or open standard surgical therapy as indicated.

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

Primary outcomes:
measure: Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair
timeFrame: 2 days post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Juliane Bingener-Casey, MD.S
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bingener J, Loomis EA, Gostout CJ, Zielinski MD, Buttar NS, Song LM, Baron TH, Ghahfarokhi LS, Rajan E. Feasibility of NOTES omental plug repair of perforated peptic ulcers: results from a clinical pilot trial. Surg Endosc. 2013 Jun;27(6):2201-8. doi: 10.1007/s00464-012-2740-3. Epub 2013 Jan 26.