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NCT01056913 Clinical Trial

NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

Inflammatory Bowel Diseases Clinical Trial

Official title:
Compression Anastomosis: Initial Clinical Experience With the ColonRingTM

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01056913
Other study ID # CT2
Secondary ID
Status Completed
Phase Phase 4
First received January 24, 2010
Last updated December 11, 2013
Start date October 2008
Est. completion date September 2010

Study information
Verified date December 2013
Source St John of God Hospital, Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial Summary

After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. The NITICAR27 device is a novel compression anastomosis device. The investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- benign and malign lesions of the colon and rectum

Exclusion Criteria:

- advanced peritonitis (putrid, feculent)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Compression Anastomosis Device
Restoring intestinal continuity using the NITI CAR27 device
Other:
• follow-up colonoscopy
endoscopic exploration of anastomosis after complete healing

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
St John of God Hospital, Vienna

Outcome
Type Measure Description Time frame Safety issue
Primary Anastomotic Leakage 4-8 weeks Yes
Secondary Clinical Relevant Stenosis six months No
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