Clinical Trial: Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus
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 Summary:
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.
Sponsor: Mayo Clinic
Current Primary Outcome: Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair [ Time Frame: 2 days post-operation ]
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.
Original Primary Outcome: Successful completion of the procedure. At the time of surgery the repair will be pressure tested using endoscopic insufflation. Post-op all patients will undergo Gastrografin swallow to evaluate for leak. [ Time Frame: Leak Evaluation during surgery and 2 days post-op ]
Current Secondary Outcome:
Original Secondary Outcome: Secondary outcome data such as pain score and quality of life, heart rate variability analysis will be collected to establish pilot data for possible future trials if feasibility is established. [ Time Frame: 12 months ]
Information By: Mayo Clinic
Dates:
Date Received: March 2, 2010
Date Started: March 2010
Date Completion:
Last Updated: April 1, 2015
Last Verified: April 2015
