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NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bernhard Dauser, MD, St John of God Hospital, Vienna
ClinicalTrials.gov Identifier:
NCT01056913
First received: January 24, 2010
Last updated: December 13, 2012
Last verified: September 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compression Anastomosis: Initial Clinical Experience With the ColonRingTM

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Anastomotic leakage [ Time Frame: 4-8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical relevant stenosis [ Time Frame: six months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • benign and malign lesions of the colon and rectum

Exclusion Criteria:

  • advanced peritonitis (putrid, feculent)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056913

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

Additional Information:
About BioDynamix Anastomosis  This link exits the ClinicalTrials.gov site

No publications provided by St John of God Hospital, Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bernhard Dauser, MD, MD, St John of God Hospital, Vienna
ClinicalTrials.gov Identifier: NCT01056913     History of Changes
Other Study ID Numbers: CT2
Study First Received: January 24, 2010
Last Updated: December 13, 2012
Health Authority: Austria: Ethikkommission

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

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

ClinicalTrials.gov processed this record on May 16, 2013