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

novoGI171 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

171

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Rate of anastomotic leakage

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.

Time frame: 2-mo post-op

Secondary Outcomes

Rate of other device related complications and measures during hospitalization and post procedure:

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)