Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis (RETROPRESS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01301417|
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : June 5, 2013
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.
|Condition or disease||Intervention/treatment|
|Diverticulum, Colon Colorectal Neoplasms Crohn Disease Colitis, Ulcerative Colostomy Ileostomy - Stoma Rectal Prolapse Intestinal Polyposis Lymphoma Endometriosis Intestinal Volvulus||Device: ColonRing™|
|Study Type :||Observational|
|Actual Enrollment :||171 participants|
|Official Title:||a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 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
- Rate of anastomotic leakage [ Time Frame: 2-mo post-op ]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 ]
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301417
|United States, Georgia|
|Southern Regional Medical Center|
|Riverdale, Georgia, United States, 30274|
|Study Director:||Eran Choman, Msc||novoGI|