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

Completed

• Conditions: Diverticulum, Colon; Colorectal Neoplasms; Crohn Disease; Colitis, Ulcerative; Colostomy; Ileostomy - Stoma; Rectal Prolapse; Intestinal Polyposis; Lymphoma; Endometriosis
• Interventions: Device: ColonRing™

• Registration Number: NCT01301417
• Lead Sponsor: novoGI

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-20
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-04
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ColonRing™	ColonRing™	Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Southern Regional Medical Center; 🇺🇸 Riverdale, Georgia, United States