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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic closure of gastrointestinal fistulas and perforations | Procedure | novel endoscopic tissue closure devices will be used for endoscopic closure of gastrointestinal fistulas or perforations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | elective endoscopy to evaluate tissue closure | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lee L Swanstrom, MD | Contact | 503 281 0561 | lswanstrom@aol.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hospital, Legacy Health System | Recruiting | Portland | Oregon | 97210 | United States |
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| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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