This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

This study has been completed.
Information provided by (Responsible Party):
Bernhard Dauser, MD, St John of God Hospital, Vienna Identifier:
First received: January 24, 2010
Last updated: December 11, 2013
Last verified: December 2013
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 Intervention Phase
Colonic Neoplasms Rectal Neoplasms Diverticulitis Inflammatory Bowel Diseases Rectal Prolapse Device: Compression Anastomosis Device Other: follow-up colonoscopy Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by Bernhard Dauser, MD, St John of God Hospital, Vienna:

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

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

Enrollment: 62
Study Start Date: October 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01056913

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

Additional Information:
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
Study First Received: January 24, 2010
Results First Received: December 11, 2013
Last Updated: December 11, 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:
Colonic Neoplasms
Inflammatory Bowel Diseases
Rectal 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 processed this record on September 21, 2017