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

Study Overview
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Brief Summary
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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.

Official Title
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a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™

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

Intervention / Treatment
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* Device: ColonRing™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ColonRing™<br>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™<br>* Creation of a circular Compression Anastomosis<br>* Other names: Compression Anaqstomosis Ring™(CAR™)27;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2-mo post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2-mo post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compression Anastomosis