Clinical Trial: A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417

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 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures.

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: The rate of anastomotic leakage. [ Time Frame: 6 weeks after the procedure ]

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: 6 weeks after the procedure. ]

The Following complications will be examined:

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)

The following post operative measures will be reported:

Hospitalization duration (two dates will be recorded: ready for discharge and discharge). The latter noting where the patient was discharged to - e.g. nursing home or home. First day to first postoperative flatus. First day to first postoperative bowel movements. First day of first postoperative toleration of liquids and solids (time to "keeping them down")



Original Secondary Outcome: Same as current

Information By: novoGI

Dates:
Date Received: June 16, 2013
Date Started: October 2012
Date Completion: July 2013
Last Updated: June 16, 2013
Last Verified: June 2013