Endoscopic Treatment of Intestinal Fistulas and Perforations
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.
Expected results: The potential advantages to the patients entered into this study result from the avoidance of open or laparoscopic surgery with the related risks (bleeding, injury of organs, post operative wound infection, hernia), shorter hospital stay, reduced postoperative pain, earlier return to work, and cosmetic advantage.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Closure of Fistulas and Perforations Endoscopically to Avoid Laparoscopic or Open Surgery|
- fistula or perforation closure possible; yes or no [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
- fistula stays closed after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- quality of life comparison, pre-op and after 6 months post-op [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Procedure: gastro-gastric fistula closure
- Tissue Apposition System
- 510(k) approval # K070151
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835458
|United States, Oregon|
|Good Samaritan Hospital, Legacy Health System|
|Portland, Oregon, United States, 97210|
|Principal Investigator:||Lee L Swanstrom, MD, FACS||Legacy Health System|