Endoscopic Treatment of Intestinal Fistulas and Perforations
- Conditions
- Gastrointestinal FistulaGastrointestinal Perforation
- Registration Number
- NCT01303653
- Lead Sponsor
- The Oregon Clinic
- Brief Summary
Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.
- Detailed Description
Novel endoscopic devices have the potential to overcome the need for invasive surgery for the treatment of gastrointestinal fistulas or perforations.
Instead of a large abdominal incision or multiple incisions with the related postoperative morbidity endoscopic techniques will be used used which require no postoperative limitation of activities. Using novel tissue closure devices, such as a Tissue Apposition System or an endoscopic suturing system, we will evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in patients having either chronic gastrointestinal fistulas or acute perforations.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
- Gastrointestinal fistula and perforation
- Ability to undergo general anesthesia
- Ability to give informed consent
- Contraindicated for esophagogastroduodenoscopy (EGD)
- Contraindicated for colonoscopy
- BMI ≥ 40
- Presence of esophageal stricture
- Altered gastric anatomy
- Intraabdominal abscess or severe inflammation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of participants with adverse events as a measure of safety and tolerability 6 months elective endoscopy to evaluate tissue closure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Good Samaritan Hospital, Legacy Health System
🇺🇸Portland, Oregon, United States