Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

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.
 
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

Tracking Information
First Submitted Date  ICMJE January 24, 2010
First Posted Date  ICMJE January 26, 2010
Results First Submitted Date  ICMJE December 11, 2013
Results First Posted Date  ICMJE January 29, 2014
Last Update Posted Date January 29, 2014
Study Start Date  ICMJE October 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
Anastomotic Leakage [ Time Frame: 4-8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01056913 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
Clinical Relevant Stenosis [ Time Frame: six months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
Official Title  ICMJE Compression Anastomosis: Initial Clinical Experience With the ColonRingTM
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Diverticulitis
  • Inflammatory Bowel Diseases
  • Rectal Prolapse
Intervention  ICMJE
  • 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
Study Arms  ICMJE NITI CAR27 (ColonRing)
Interventions:
  • Device: Compression Anastomosis Device
  • Other: follow-up colonoscopy
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2010)
62
Original Actual Enrollment  ICMJE
 (submitted: January 25, 2010)
50
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • benign and malign lesions of the colon and rectum

Exclusion Criteria:

  • advanced peritonitis (putrid, feculent)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01056913
Other Study ID Numbers  ICMJE CT2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bernhard Dauser, MD, St John of God Hospital, Vienna
Study Sponsor  ICMJE St John of God Hospital, Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Friedrich Herbst, MD, FRCS St John of God Hospital, Vienna
PRS Account St John of God Hospital, Vienna
Verification Date December 2013

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