Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis (RETROPRESS)
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 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.
Ileostomy - Stoma
|Study Design:||Time Perspective: Retrospective|
|Official Title:||a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™|
- Rate of anastomotic leakage [ Time Frame: 2-mo post-op ] [ Designated as safety issue: Yes ]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.
- Rate of other device related complications and measures during hospitalization and post procedure: [ Time Frame: 2-mo post-op ] [ Designated as safety issue: Yes ]
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)
|Study Start Date:||February 2011|
Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice
Creation of a circular Compression Anastomosis
Other Name: Compression Anaqstomosis Ring™(CAR™)27
|United States, Georgia|
|Southern Regional Medical Center||Recruiting|
|Riverdale, Georgia, United States, 30274|
|Contact: Stephen Cohen, MD 770-997-1975 email@example.com|
|Contact: Susan Honea 770-9971975 firstname.lastname@example.org|
|Principal Investigator: Stephen Cohen, MD|
|Study Director:||Yael Nir, MD||NiTi Surgical Solutions Ltd.|