Trial Outcomes & Findings for NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery (NCT NCT01056913)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

62 participants

Primary outcome timeframe

4-8 weeks

Results posted on

2014-01-29

Participant milestones
Measure	NITI CAR27 (ColonRing) Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing
Overall Study STARTED	62
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	0

Withdrawal data not reported

NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

Baseline characteristics by cohort
Measure	NITI CAR27 (ColonRing) n=62 Participants Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants

Timeframe: 4-8 weeks

Outcome measures
Measure	NITI CAR27 (ColonRing) n=62 Participants Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing
Anastomotic Leakage	0 participants

Timeframe: six months

Outcome data not reported

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	NITI CAR27 (ColonRing) n=62 participants at risk Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing
Gastrointestinal disorders Anastomotic stenosis	3.2% 2/62 • Number of events 2

Adverse event data not reported

St John of God Hospital Vienna

Phone: +43121121