Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27
NCT ID: NCT01056796
Last Updated: 2011-06-30
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
PHASE2
10 participants
INTERVENTIONAL
2010-01-31
2012-05-31
Brief Summary
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Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAR™ 27
Any patient with a diagnosis of colorectal cancer that has been previously radiated to the pelvic area (6-8 weeks prior to surgery) and that is electively scheduled for an open or laparoscopic total mesorectal excision (TME) and low anterior resection surgery (\< 10cm from the anal verge) which requires the creation of an anastomosis, will be offered participation in this study.
CAR™ 27
Creation of a low colorectal (side or pouch low rectal) compression anastomosis in previously radiated patients
Interventions
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CAR™ 27
Creation of a low colorectal (side or pouch low rectal) compression anastomosis in previously radiated patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is scheduled for a non-emergency TME and low anterior resection (\< 10cm from the anal verge).
* Patient has been radiated to the pelvic area 6-8 weeks prior to the study.
* Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
Exclusion Criteria
* Patient undergoing an emergency procedure or has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease.
* Patients are participating in another clinical trial which may affect this study's outcomes.
* Patient has been taking regular steroid medication.
* Patient has contraindications to general anesthesia.
* Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
18 Years
ALL
No
Sponsors
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University Hospital, Gasthuisberg
OTHER
Niti Medical Technologies Ltd.
INDUSTRY
Responsible Party
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Gasthuisberg University Hospital, Leuven, Belgium
Principal Investigators
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Andre D'Hoore, Professor
Role: PRINCIPAL_INVESTIGATOR
Gasthuisberg University Hospital
Locations
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University Hospital, Gasthuisberg
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Andre D'Hoore, Professor
Role: primary
Guido Van Ermen, Mr.
Role: backup
Other Identifiers
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Version: January 6, 2010
Identifier Type: -
Identifier Source: org_study_id