NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056913
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : January 29, 2014
Last Update Posted : January 29, 2014
Information provided by (Responsible Party):
Bernhard Dauser, MD, 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.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Rectal Neoplasms Diverticulitis Inflammatory Bowel Diseases Rectal Prolapse Device: Compression Anastomosis Device Other: follow-up colonoscopy Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compression Anastomosis: Initial Clinical Experience With the ColonRingTM
Study Start Date : October 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
NITI CAR27 (ColonRing) Device: Compression Anastomosis Device
Restoring intestinal continuity using the NITI CAR27 device
Other Names:
  • ColonRing
  • BioDynamix Anastomosis

Other: follow-up colonoscopy
endoscopic exploration of anastomosis after complete healing

Primary Outcome Measures :
  1. Anastomotic Leakage [ Time Frame: 4-8 weeks ]

Secondary Outcome Measures :
  1. Clinical Relevant Stenosis [ Time Frame: six months ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • benign and malign lesions of the colon and rectum

Exclusion Criteria:

  • advanced peritonitis (putrid, feculent)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056913

Sponsors and Collaborators
St John of God Hospital, Vienna
Principal Investigator: Friedrich Herbst, MD, FRCS St John of God Hospital, Vienna

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bernhard Dauser, MD, MD, St John of God Hospital, Vienna Identifier: NCT01056913     History of Changes
Other Study ID Numbers: CT2
First Posted: January 26, 2010    Key Record Dates
Results First Posted: January 29, 2014
Last Update Posted: January 29, 2014
Last Verified: December 2013

Keywords provided by Bernhard Dauser, MD, St John of God Hospital, Vienna:
anastomotic leakage
bleeding from the anastomotic region
anastomotic stenosis

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Rectal Neoplasms
Colonic Neoplasms
Rectal Prolapse
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intraabdominal Infections
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Rectal Diseases
Colonic Diseases
Pelvic Organ Prolapse