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A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing

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. Identifier: NCT01880918
Recruitment Status : Unknown
Verified June 2013 by novoGI.
Recruitment status was:  Recruiting
First Posted : June 19, 2013
Last Update Posted : June 19, 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 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.

Condition or disease
Diverticulum, Colon Colorectal Neoplasms Crohn Disease Colitis, Ulcerative Colostomy Ileostomy - Stoma Rectal Prolapse Intestinal Polyposis Lymphoma Endometriosis Intestinal Volvulus

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Study Type : Observational
Estimated Enrollment : 200 participants
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
Study Start Date : October 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. The rate of anastomotic leakage. [ Time Frame: 6 weeks after the procedure ]
    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: 6 weeks after the procedure. ]

    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")

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patient was > 18 years old at time of procedure
  2. Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
  3. Patient treated in routine clinical practice
  4. 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 identifier (NCT number): NCT01880918

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United States, Florida
Florida Hospital, Center for Colon & Rectal Surgery Recruiting
Atlamonte Springs, Florida, United States, 32701
Contact: Dr. Matthew Albert, MD    407-303-5191      
Contact: Leslee Cunnion    407-303-5191   
Principal Investigator: Dr. Matthew Albert, MD         
18308 Murdock Circle, Suite 108 Recruiting
Port Charlotte, Florida, United States
Contact: Dr. Domingo E. Galliano Jr., MD    941-625-3411   
Contact: Kathleen Lueck         
Principal Investigator: Dr. Domingo E. Galiano Jr., MD         
United States, Missouri
CoxHealth Hospital, Colorectal Department Recruiting
Springfield, Missouri, United States, 65807
Contact: Dr. Jose Dominguez, MD    417-875-3211      
Contact: Kami Oster    417- 875-3211   
Principal Investigator: Dr. Jose Dominguez, MD         
Sponsors and Collaborators
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Responsible Party: novoGI Identifier: NCT01880918    
Other Study ID Numbers: RETROPRESS, CLPR-43-11-01
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by novoGI:
Compression Anastomosis
Additional relevant MeSH terms:
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Diverticulum, Colon
Colorectal Neoplasms
Crohn Disease
Colitis, Ulcerative
Rectal Prolapse
Intestinal Volvulus
Intestinal Polyposis
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathological Conditions, Anatomical
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Rectal Diseases
Pelvic Organ Prolapse
Diverticular Diseases
Intraabdominal Infections
Intestinal Obstruction
Torsion Abnormality