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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	novoGI
ClinicalTrials.gov Identifier:	NCT01301417 History of Changes
Other Study ID Numbers:	RETROPRESS
First Posted:	February 23, 2011
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