Gastric Fistula Clinical Trial
Official title:
Closure of Fistulas and Perforations Endoscopically to Avoid Laparoscopic or Open Surgery
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT03123835 -
Outcome Analysis of POEM and Endoluminal Therapies
|
N/A |