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A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by novoGI
Sponsor:
Information provided by (Responsible Party):
novoGI
ClinicalTrials.gov Identifier:
NCT01880918
First received: June 16, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by novoGI:

Primary Outcome Measures:
  • The rate of anastomotic leakage. [ Time Frame: 6 weeks after the procedure ] [ Designated as safety issue: Yes ]
    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:
  • Rate of other device related complications and measures during hospitalization and post procedure. [ Time Frame: 6 weeks after the procedure. ] [ Designated as safety issue: Yes ]

    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")



Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
ColonRing
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880918

Locations
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    Leslee.Cunnion@flhosp.org   
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    office@gallianosurgery.com   
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    Kami.Oster@coxhealth.com   
Principal Investigator: Dr. Jose Dominguez, MD         
Sponsors and Collaborators
novoGI
  More Information

No publications provided

Responsible Party: novoGI
ClinicalTrials.gov Identifier: NCT01880918     History of Changes
Other Study ID Numbers: RETROPRESS, CLPR-43-11-01
Study First Received: June 16, 2013
Last Updated: June 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by novoGI:
Compression Anastomosis

Additional relevant MeSH terms:
Colitis, Ulcerative
Colorectal Neoplasms
Crohn Disease
Diverticulum
Diverticulum, Colon
Endometriosis
Intestinal Polyposis
Intestinal Volvulus
Rectal Prolapse
Colitis
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Inflammatory Bowel Diseases
Intestinal Diseases
Intestinal Neoplasms
Intestinal Obstruction
Neoplasms
Neoplasms by Site
Pathological Conditions, Anatomical
Pelvic Organ Prolapse
Prolapse
Rectal Diseases
Torsion Abnormality

ClinicalTrials.gov processed this record on November 27, 2014