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Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis (RETROPRESS)

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ClinicalTrials.gov Identifier: NCT01301417
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : June 5, 2013
Information provided by (Responsible Party):

Brief Summary:

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
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice.

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.

Information from the National Library of Medicine

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
Sponsors and Collaborators
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
Colorectal Neoplasms
Colitis, Ulcerative
Rectal Prolapse
Intestinal Polyposis
Intestinal Volvulus
Diverticulum, Colon
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Genital Diseases, Female
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Rectal Diseases
Pelvic Organ Prolapse
Intestinal Obstruction
Torsion Abnormality