Endoscopic Treatment of Intestinal Fistulas and Perforations

Not Applicable

• Conditions: Gastric Fistula

• Registration Number: NCT00835458
• Lead Sponsor: Legacy Health System

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.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-02
• Study Start: 2009-02
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Last Update Submitted: 2009-02-10
• Last Update Posted: 2009-02-11
• Primary Completion: 2009-10
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Ability to undergo general anesthesia
• Age > 18 yrs. of age and < 85 yrs. of age
• Ability to give informed consent

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Exclusion Criteria

• Contraindicated for esophagogastroduodenoscopy (EGD)
• Contraindicated for colonoscopy
• BMI < 40
• Presence of esophageal stricture
• Altered gastric anatomy
• Intraabdominal abscess or severe inflammation
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
fistula or perforation closure possible; yes or no	day of surgery

Secondary Outcome Measures

Name	Time	Method
fistula stays closed after 6 months	6 months
quality of life comparison, pre-op and after 6 months post-op	6 months

Trial Locations

Locations (1)

Good Samaritan Hospital, Legacy Health System; 🇺🇸 Portland, Oregon, United States