NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

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.

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Key information

Conditions

Colonic Neoplasms Anastomotic Leak Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Diverticular Diseases Diverticulitis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Postoperative Complications Prolapse Rectal Diseases Rectal Neoplasms Rectal Prolapse

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

benign and malign lesions of the colon and rectum

Exclusion criteria

advanced peritonitis (putrid, feculent)

Treatment and study plan

Compression Anastomosis Device

Device

Restoring intestinal continuity using the NITI CAR27 device

Other names: ColonRing, BioDynamix Anastomosis

follow-up colonoscopy

Other

endoscopic exploration of anastomosis after complete healing

Primary outcomes

Anastomotic Leakage

Time frame: 4-8 weeks

Secondary outcomes

Clinical Relevant Stenosis

Time frame: six months

Sponsors and collaborators

Lead sponsor

St John of God Hospital, Vienna

Other

Registry information

Official study title

Compression Anastomosis: Initial Clinical Experience With the ColonRingTM

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Jan 26, 2010
Registry last updated: Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed