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 ]

The primary study outcome is the rate of anastomotic leakage. Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.


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