NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

Phase 4

Completed

• Conditions: Rectal Prolapse; Rectal Neoplasms; Inflammatory Bowel Diseases; Colonic Neoplasms; Diverticulitis
• Interventions: Device: Compression Anastomosis Device; Other: follow-up colonoscopy

• Registration Number: NCT01056913
• Lead Sponsor: St John of God Hospital, Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2010-01-24
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2013-12
• Results First Submitted: 2013-12-11
• Results First Submitted QC: 2013-12-11
• Last Update Submitted: 2013-12-11
• Results First Posted: 2014-01-29
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• benign and malign lesions of the colon and rectum

Exclusion Criteria

• advanced peritonitis (putrid, feculent)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NITI CAR27 (ColonRing)	follow-up colonoscopy	-
NITI CAR27 (ColonRing)	Compression Anastomosis Device	-

Primary Outcome Measures

Name	Time	Method
Anastomotic Leakage	4-8 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical Relevant Stenosis	six months