Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis - Full Text View

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


Study Type:	Observational
Study Design:	Time Perspective: Retrospective
Official Title:	a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphosarcoma

U.S. FDA Resources

Further study details as provided by novoGI:

Primary Outcome Measures:

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:

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)


Enrollment:	171
Study Start Date:	February 2011
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility


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.

Criteria

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.

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: NCT01301417

Locations


United States, Georgia
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274

Sponsors and Collaborators

novoGI

Investigators


Study Director:	Eran Choman, Msc	novoGI

More Information


Responsible Party:	novoGI
ClinicalTrials.gov Identifier:	NCT01301417 History of Changes
Other Study ID Numbers:	RETROPRESS
Study First Received:	February 20, 2011
Last Updated:	June 4, 2013

Keywords provided by novoGI:


Compression Anastomosis

Additional relevant MeSH terms:


Crohn Disease Prolapse Endometriosis Colorectal Neoplasms Colitis, Ulcerative Rectal Prolapse Diverticulum Intestinal Polyposis Intestinal Volvulus Diverticulum, Colon 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

ClinicalTrials.gov processed this record on July 19, 2017

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