Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27

Study Overview
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Brief Summary
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The purpose of this study is: Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.

Official Title
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Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: CAR™ 27


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 18 years old. Patient is scheduled for a non-emergency TME and low anterior resection (< 10cm from the anal verge). Patient has been radiated to the pelvic area 6-8 weeks prior to the study. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures. Exclusion Criteria: Patient has known allergy to nickel. Patient undergoing an emergency procedure or has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease. Patients are participating in another clinical trial which may affect this study's outcomes. Patient has been taking regular steroid medication. Patient has contraindications to general anesthesia. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAR™ 27<br>Any patient with a diagnosis of colorectal cancer that has been previously radiated to the pelvic area (6-8 weeks prior to surgery) and that is electively scheduled for an open or laparoscopic total mesorectal excision (TME) and low anterior resection surgery (< 10cm from the anal verge) which requires the creation of an anastomosis, will be offered participation in this study. | Device: CAR™ 27<br>* Creation of a low colorectal (side or pouch low rectal) compression anastomosis in previously radiated patients<br>* Other names: Compression Anastomosis Ring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate for the occurrence of adverse events related to the use of the CAR™ 27 device, include anastomotic leak, bleeding, ring evacuation and strictures at 6 months. |  | Approx. 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients |  | Approx. 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compression anastomosis, Colorectal cancer, Low anterior resection, Radiated to the pelvic area, Radiotherapy