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NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
This study has been completed.
Sponsor:
St John of God Hospital, Vienna
Information provided by (Responsible Party):
Bernhard Dauser, MD, St John of God Hospital, Vienna
ClinicalTrials.gov Identifier:
NCT01056913
First received: January 24, 2010
Last updated: December 11, 2013
Last verified: December 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Colonic Neoplasms Rectal Neoplasms Diverticulitis Inflammatory Bowel Diseases Rectal Prolapse | Device: Compression Anastomosis Device Other: follow-up colonoscopy | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Compression Anastomosis: Initial Clinical Experience With the ColonRingTM |
Further study details as provided by Bernhard Dauser, MD, St John of God Hospital, Vienna:
Primary Outcome Measures:
- Anastomotic Leakage [ Time Frame: 4-8 weeks ]
Secondary Outcome Measures:
- Clinical Relevant Stenosis [ Time Frame: six months ]
| Enrollment: | 62 |
| Study Start Date: | October 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| NITI CAR27 (ColonRing) |
Device: Compression Anastomosis Device
Restoring intestinal continuity using the NITI CAR27 device
Other Names:
Other: follow-up colonoscopy
endoscopic exploration of anastomosis after complete healing
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- benign and malign lesions of the colon and rectum
Exclusion Criteria:
- advanced peritonitis (putrid, feculent)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01056913
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056913
Sponsors and Collaborators
St John of God Hospital, Vienna
Investigators
| Principal Investigator: | Friedrich Herbst, MD, FRCS | St John of God Hospital, Vienna |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bernhard Dauser, MD, MD, St John of God Hospital, Vienna |
| ClinicalTrials.gov Identifier: | NCT01056913 History of Changes |
| Other Study ID Numbers: |
CT2 |
| Study First Received: | January 24, 2010 |
| Results First Received: | December 11, 2013 |
| Last Updated: | December 11, 2013 |
Keywords provided by Bernhard Dauser, MD, St John of God Hospital, Vienna:
|
anastomotic leakage bleeding from the anastomotic region anastomotic stenosis |
Additional relevant MeSH terms:
|
Colonic Neoplasms Neoplasms Inflammatory Bowel Diseases Prolapse Diverticulitis Rectal Prolapse Rectal Neoplasms Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Pathological Conditions, Anatomical Intraabdominal Infections Infection Rectal Diseases Pelvic Organ Prolapse Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Colonic Diseases |
ClinicalTrials.gov processed this record on June 28, 2017