Clinical Trial: Endoscopic Treatment of Intestinal Fistulas and Perforations
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Endoscopic Treatment of Intestinal Fistulas and Perforations
Brief Summary:
Background: T-shaped tissue anchors have promise to close incisions and perforations of the intestines securely. The closure of perforations, gastro-gastric, or intestinal fistulas usually requires invasive open or laparoscopic surgery under general anesthesia and can be complex surgeries due to their reoperative or inflammatory nature.
Objective: The proposed use of full thickness tissue anchors adds a new surgical aspect to the endoscopic treatment of fistulas and perforations by offering a robust suture like closure of defects. Instead of a 20 cm abdominal incision or 3 or 4 one centimeter incisions with the related postoperative morbidity an endoscopic technique is used which requires no postoperative limitation of activities.
Methods: In this study the investigators propose to use an endoscopic technique that eliminates the need for open or laparoscopic surgery and provides a more robust endoscopic repair than is possible with traditional endoscopic tools. Patients who are scheduled to undergo surgery for intestinal fistulas will be screened for study eligibility. Patients who are scheduled to undergo complex polypectomy, or submucosal dissection will be screened for study eligibility and informed about all possible therapies in case of an iatrogenic perforation (open - laparoscopic surgery, endoscopic clipping, endoscopic closure with tissue anchors). A commercially available flexible endoscope will be inserted through the mouth and the fistula or perforation will be closed using the Tissue Approximation System (Ethicon Endo Surgery, Cincinnati, OH).
The investigators will initially evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in 5 patients.
Expec
Detailed Summary:
Sponsor: Legacy Health System
Current Primary Outcome: fistula or perforation closure possible; yes or no [ Time Frame: day of surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- fistula stays closed after 6 months [ Time Frame: 6 months ]
- quality of life comparison, pre-op and after 6 months post-op [ Time Frame: 6 months ]
Original Secondary Outcome:
Information By: Legacy Health System
Dates:
Date Received: February 24, 2011
Date Started: October 2010
Date Completion: December 2010
Last Updated: February 10, 2009
Last Verified: February 2009
