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

Sponsor

novoGI (Industry)

Overall Status

Completed

CT.gov ID

NCT01301417

Collaborator

(none)

171

Enrollment

Location

5.9

Duration (Months)

28.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

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 :

Feb 1, 2011

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	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 Names: Compression Anaqstomosis Ring™(CAR™)27

Arm

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 Names:

Compression Anaqstomosis Ring™(CAR™)27

Outcome Measures

Primary Outcome Measures

Rate of anastomotic leakage [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: [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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