Clinical Trial: Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™
Brief Summary:
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center. The data will assist in further evaluating the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.
Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.
Detailed Summary:
Sponsor: novoGI
Current Primary Outcome: Rate of anastomotic leakage [ Time Frame: 2-mo post-op ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Rate of other device related complications and measures during hospitalization and post procedure: [ Time Frame: 2-mo post-op ]
The following complications will be examined for relation to the device:
Bleeding. Stricture (either clinical evidence of a stricture or the inability to pass a 12 mm sigmoidoscope through the anastomosis in a procedure that does not include a diversion). Septic complication (including wound infection, pelvic infection, peritonitis, abscess).
Readmission, re-operation, death within two months of the procedure. Extra colonic complications (including urinary infection, urinary retention, DVT, pneumonitis, pulmonary embolism, cardiac, injury to other organs - e.g. spleen, ureter)
Original Secondary Outcome: Same as current
Information By: novoGI
Dates:
Date Received: February 20, 2011
Date Started: February 2011
Date Completion:
Last Updated: June 4, 2013
Last Verified: June 2013