Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diverticulum, Colon
- Sponsor
- novoGI
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- The rate of anastomotic leakage.
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient was \> 18 years old at time of procedure
- •Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
- •Patient treated in routine clinical practice
- •Patient underwent his/her first follow-up visit within two months post-surgery
Exclusion Criteria
- •No exclusion criteria have been defined for this data collection.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Rate of other device related complications and measures during hospitalization and post procedure.(6 weeks after the procedure.)