A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
Recruitment status was: Recruiting
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.
Ileostomy - Stoma
|Study Design:||Time Perspective: Retrospective|
|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|
- The rate of anastomotic leakage. [ Time Frame: 6 weeks after the procedure ] [ Designated as safety issue: Yes ]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.
- Rate of other device related complications and measures during hospitalization and post procedure. [ Time Frame: 6 weeks after the procedure. ] [ Designated as safety issue: Yes ]
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")
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
The ColonRing device is intended to be used for the creation of intestinal anastomoses in colorectal surgery in both open and laparoscopic surgeries. This indication is within the currently cleared indication of the ColonRing device, which has been cleared by the US FDA and carries the CE Mark for use throughout the alimentary trct for the creation of circular end-to-end, side-to-end or side-to-side anastomosis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01880918
|United States, Florida|
|Florida Hospital, Center for Colon & Rectal Surgery|
|Atlamonte Springs, Florida, United States, 32701|
|18308 Murdock Circle, Suite 108|
|Port Charlotte, Florida, United States|
|United States, Missouri|
|CoxHealth Hospital, Colorectal Department|
|Springfield, Missouri, United States, 65807|