Phase 4
N=62
NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
Colonic Neoplasms · Rectal Neoplasms · Diverticulitis · Inflammatory Bowel Diseases · Rectal Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT01056913 ↗Enrolled (actual)
62
Serious AEs
3.2%
Results posted
Jan 2014
Primary outcome: Primary: Anastomotic Leakage — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Compression Anastomosis Device (Device); follow-up colonoscopy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St John of God Hospital, Vienna
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anastomotic Leakage |
— | — |
| SECONDARY Clinical Relevant Stenosis |
— | — |
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.
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.