Phase 4
Completed N=62
NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
Colonic Neoplasms · rectal neoplasms · Diverticulitis · Inflammatory Bowel Disease
Source: ClinicalTrials.gov NCT01056913 ↗
Enrolled (actual)
62
Serious AEs
3.2%
Results posted
Jan 2014
Primary outcomePrimary: Anastomotic Leakage — 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anastomotic Leakage |
— | — |
| SECONDARY Clinical Relevant Stenosis |
— | — |
Eligibility Criteria
Inclusion Criteria
- benign and malign lesions of the colon and rectum
Exclusion Criteria
- advanced peritonitis (putrid, feculent)
Data sourced from ClinicalTrials.gov (NCT01056913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.