Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus

NCT01080326 | Completed Results DMC

• 2 other identifiers: 08-008389ULIRR024150
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Peptic Ulcer

Keywords

ulcer repair surgery; transluminal omental patch

Outcome Measures

Primary Outcomes (1)

• Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair

  At the time of surgery the repair was pressure tested using endoscopic insufflation. Two days post-operation all participants receiving the NOTES repair underwent a water-soluble contrast study to demonstrate leakage. Note: The NOTES procedure was attempted first if the subject had no contraindication. If this proved unsuccessful the surgical team proceeded with conversion to laparoscopic or open standard surgical therapy as indicated.

  2 days post-operation

Study Arms (1)

Endoscopic Translumenal Omental Patch

EXPERIMENTAL

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

Interventions

Endoscopic Translumenal Omental Patch DEVICE

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.

Also known as: Ulcer repair surgery

Endoscopic Translumenal Omental Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead
• Natural Orifice Surgery Consortium for Assessment and Research: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 23355151 RESULT

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Results Point of Contact

• Title: Juliane Bingener-Casey, M.D.
• Organization: Mayo Clinic

BingenerCasey.Juliane@mayo.edu

507-538-9007

Study Officials

• Juliane Bingener-Casey, MD.S

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 4, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 14, 2015
• Results First Posted: April 14, 2015

Record last verified: 2015-04

Locations

US (1)