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 11, 2013
Last verified: December 2013

January 24, 2010
December 11, 2013
October 2008
September 2010   (final data collection date for primary outcome measure)
Anastomotic Leakage [ Time Frame: 4-8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01056913 on ClinicalTrials.gov Archive Site
Clinical Relevant Stenosis [ Time Frame: six months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01056913
CT2
No
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