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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Time Perspective: | Retrospective |
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 |
Group/Cohort | Intervention/treatment |
---|---|
ColonRing™
Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice
|
Device: ColonRing™
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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patient was > 18 years old at time of procedure
- Patient underwent an open or laparoscopic colorectal procedure with the creation of an anastomosis using the ColonRing™
- Patient treated in routine clinical practice following marketing clearance of the device within the cleared intended use
- 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.

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 |
Responsible Party: | novoGI |
ClinicalTrials.gov Identifier: | NCT01301417 History of Changes |
Other Study ID Numbers: |
RETROPRESS |
First Posted: | February 23, 2011 Key Record Dates |
Last Update Posted: | June 5, 2013 |
Last Verified: | June 2013 |
Keywords provided by novoGI:
Compression Anastomosis |
Additional relevant MeSH terms:
Crohn Disease Prolapse Endometriosis Colorectal Neoplasms Colitis, Ulcerative Rectal Prolapse Diverticulum Intestinal Polyposis Diverticulum, Colon Intestinal Volvulus Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Pathological Conditions, Anatomical Genital Diseases, Female Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Colonic Diseases Rectal Diseases Colitis Pelvic Organ Prolapse Intestinal Obstruction Torsion Abnormality |