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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
January 24, 2010
January 26, 2010
December 11, 2013
January 29, 2014
January 29, 2014
October 2008
September 2010   (Final data collection date for primary outcome measure)
Anastomotic Leakage [ Time Frame: 4-8 weeks ]
Same as current
Complete list of historical versions of study NCT01056913 on ClinicalTrials.gov Archive Site
Clinical Relevant Stenosis [ Time Frame: six months ]
Same as current
Not Provided
Not Provided
 
NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
Compression Anastomosis: Initial Clinical Experience With the ColonRingTM
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Diverticulitis
  • Inflammatory Bowel Diseases
  • Rectal Prolapse
  • 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
NITI CAR27 (ColonRing)
Interventions:
  • Device: Compression Anastomosis Device
  • Other: follow-up colonoscopy
Dauser B, Winkler T, Loncsar G, Herbst F. Compression anastomosis revisited: prospective audit of short- and medium-term outcomes in 62 rectal anastomoses. World J Surg. 2011 Aug;35(8):1925-32. doi: 10.1007/s00268-011-1135-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
September 2010
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • benign and malign lesions of the colon and rectum

Exclusion Criteria:

  • advanced peritonitis (putrid, feculent)
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01056913
CT2
No
Not Provided
Not Provided
Bernhard Dauser, MD, St John of God Hospital, Vienna
St John of God Hospital, Vienna
Not Provided
Principal Investigator: Friedrich Herbst, MD, FRCS St John of God Hospital, Vienna
St John of God Hospital, Vienna
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP