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NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01056913
First Posted: January 26, 2010
Last Update Posted: January 29, 2014
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.
Information provided by (Responsible Party):
Bernhard Dauser, MD, St John of God Hospital, Vienna
  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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: January 24, 2010
First Posted: January 26, 2010
Results First Submitted: December 11, 2013
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:
Neoplasms
Inflammatory Bowel Diseases
Prolapse
Diverticulitis
Rectal Neoplasms
Colonic Neoplasms
Rectal Prolapse
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intraabdominal Infections
Infection
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Rectal Diseases
Colonic Diseases
Pelvic Organ Prolapse