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NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

Compression Anastomosis: Initial Clinical Experience With the ColonRingTM

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01056913
Enrollment
62
Registered
2010-01-26
Start date
2008-10-31
Completion date
2010-09-30
Last updated
2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Rectal Neoplasms, Rectal Prolapse

Keywords

anastomotic leakage, bleeding from the anastomotic region, anastomotic stenosis

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.

Interventions

DEVICECompression Anastomosis Device

Restoring intestinal continuity using the NITI CAR27 device

OTHERfollow-up colonoscopy

endoscopic exploration of anastomosis after complete healing

Sponsors

St John of God Hospital, Vienna
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* benign and malign lesions of the colon and rectum

Exclusion criteria

* advanced peritonitis (putrid, feculent)

Design outcomes

Primary

MeasureTime frame
Anastomotic Leakage4-8 weeks

Secondary

MeasureTime frame
Clinical Relevant Stenosissix months

Participant flow

Participants by arm

ArmCount
NITI CAR27 (ColonRing)
Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing
62
Total62

Baseline characteristics

CharacteristicNITI CAR27 (ColonRing)
Age, Continuous67 years
Sex: Female, Male
Female
30 Participants
Sex: Female, Male
Male
32 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 62
serious
Total, serious adverse events
2 / 62

Outcome results

Primary

Anastomotic Leakage

Time frame: 4-8 weeks

ArmMeasureValue (NUMBER)
NITI CAR27 (ColonRing)Anastomotic Leakage0 participants
Secondary

Clinical Relevant Stenosis

Time frame: six months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026