Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus

This study has been completed.
Sponsor:
Collaborator:
Natural Orifice Surgery Consortium for Assessment and Research
Information provided by (Responsible Party):
Juliane Bingener-Casey, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01080326
First received: March 2, 2010
Last updated: April 1, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention
Peptic Ulcer
Device: Endoscopic Translumenal Omental Patch

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair [ Time Frame: 2 days post-operation ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 7
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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.
Other Name: Ulcer repair surgery

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080326

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Natural Orifice Surgery Consortium for Assessment and Research
Investigators
Principal Investigator: Juliane Bingener-Casey, MD.S Mayo Clinic
  More Information

Publications:
Responsible Party: Juliane Bingener-Casey, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01080326     History of Changes
Other Study ID Numbers: 08-008389, ULIRR024150
Study First Received: March 2, 2010
Results First Received: April 1, 2015
Last Updated: April 1, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
ulcer repair surgery
transluminal omental patch

Additional relevant MeSH terms:
Peptic Ulcer
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Intestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 26, 2015