A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Colitis, Lymphoma, Women's Studies, Gastrointestinal, Crohns Disease, Endometriosis |
| Therapuetic Areas: | Gastroenterology, Oncology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2012 |
| End Date: | July 2013 |
Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417
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.
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.
Inclusion Criteria:
1. Patient was > 18 years old at time of procedure
2. Patient underwent a technically successful open or laparoscopic colorectal, Low
Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
3. Patient treated in routine clinical practice
4. 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.
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