NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
Primary Purpose
Colonic Neoplasms, Rectal Neoplasms, Diverticulitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Compression Anastomosis Device
follow-up colonoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Neoplasms focused on measuring anastomotic leakage, bleeding from the anastomotic region, anastomotic stenosis
Eligibility Criteria
Inclusion Criteria:
- benign and malign lesions of the colon and rectum
Exclusion Criteria:
- advanced peritonitis (putrid, feculent)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
NITI CAR27 (ColonRing)
Arm Description
Outcomes
Primary Outcome Measures
Anastomotic Leakage
Secondary Outcome Measures
Clinical Relevant Stenosis
Full Information
NCT ID
NCT01056913
First Posted
January 24, 2010
Last Updated
December 11, 2013
Sponsor
St John of God Hospital, Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01056913
Brief Title
NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
Official Title
Compression Anastomosis: Initial Clinical Experience With the ColonRingTM
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St John of God Hospital, Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Rectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Rectal Prolapse
Keywords
anastomotic leakage, bleeding from the anastomotic region, anastomotic stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NITI CAR27 (ColonRing)
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Compression Anastomosis Device
Other Intervention Name(s)
ColonRing, BioDynamix Anastomosis
Intervention Description
Restoring intestinal continuity using the NITI CAR27 device
Intervention Type
Other
Intervention Name(s)
follow-up colonoscopy
Intervention Description
endoscopic exploration of anastomosis after complete healing
Primary Outcome Measure Information:
Title
Anastomotic Leakage
Time Frame
4-8 weeks
Secondary Outcome Measure Information:
Title
Clinical Relevant Stenosis
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
benign and malign lesions of the colon and rectum
Exclusion Criteria:
advanced peritonitis (putrid, feculent)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedrich Herbst, MD, FRCS
Organizational Affiliation
St John of God Hospital, Vienna
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21541799
Citation
Dauser B, Winkler T, Loncsar G, Herbst F. Compression anastomosis revisited: prospective audit of short- and medium-term outcomes in 62 rectal anastomoses. World J Surg. 2011 Aug;35(8):1925-32. doi: 10.1007/s00268-011-1135-2.
Results Reference
derived
Links:
URL
http://www.nitisurgical.com
Description
About BioDynamix Anastomosis
Learn more about this trial
NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
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