Endoscopic Treatment of Intestinal Fistulas and Perforations
NCT ID: NCT01303653
Last Updated: 2011-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
25 participants
INTERVENTIONAL
2010-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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endoscopic closure of gastrointestinal fistulas and perforations
novel endoscopic tissue closure devices will be used for endoscopic closure of gastrointestinal fistulas or perforations
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to undergo general anesthesia
* Ability to give informed consent
Exclusion Criteria
* Contraindicated for colonoscopy
* BMI ≥ 40
* Presence of esophageal stricture
* Altered gastric anatomy
* Intraabdominal abscess or severe inflammation
18 Years
85 Years
ALL
No
Sponsors
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The Oregon Clinic
OTHER
Responsible Party
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The Oregon Clinic
Locations
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Good Samaritan Hospital, Legacy Health System
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Lee L Swanstrom, MD
Role: primary
Other Identifiers
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LEG 1280
Identifier Type: -
Identifier Source: org_study_id