Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus

NCT ID: NCT01080326

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-12-31

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.

Conditions

Peptic Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Endoscopic Translumenal Omental Patch

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.

Group Type: EXPERIMENTAL

Endoscopic Translumenal Omental Patch

Intervention Type: 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.

Interventions

Endoscopic Translumenal Omental Patch

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.

Intervention Type: DEVICE

Other Intervention Names

Ulcer repair surgery

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Natural Orifice Surgery Consortium for Assessment and Research

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Juliane Bingener-Casey

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juliane Bingener-Casey, MD.S

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23355151 (View on PubMed)

Other Identifiers

ULIRR024150

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

08-008389

Identifier Type: -

Identifier Source: org_study_id