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NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT01056913
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : January 29, 2014
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Bernhard Dauser, MD, St John of God Hospital, Vienna

Study Description
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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 Design
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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
Arms and Interventions
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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


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

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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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 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:
Colonic Neoplasms
Neoplasms
Inflammatory Bowel Diseases
Prolapse
Diverticulitis
Rectal 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