Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery

Study Overview
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Brief Summary
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Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery.

Detailed Description
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Study is designed as a prospective enrollment of patients undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. Patients who are scheduled for elective resection of the left, anterior and low anterior colon can be enrolled in the study.

Official Title
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Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: Staple line reinforcement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must comply with follow-up evaluations Patient or representative must provide informed consent prior to enrollment Patient scheduled for elective surgical excision of the left, anterior or low anterior colon Patient must meet all criteria and be eligible to have open or laparoscopic colorectal surgery with primary anastomosis at one location Exclusion Criteria: Crohns disease Emergency colorectal surgery for trauma, obstruction, ischemic bowel, perforated diverticulum and all other emergent diagnosis. Patients who have not had mechanical bowel preparation Patients with known documented sensitivity/allergy to bovine material Severe radiation damage to tissue Carcinomatosis or stage IV cancer BMI is 35 or greater Cancer at primary anastomosis site that cannot be excised Patients who require an ileo rectal anastomosis Surgery anticipated to include jejunostomy pouch Anticipated diverting stoma No anti adhesive barrier can be used around anastomotic site No multiple circular anastomosis Surgeons discretion to exclude any patient he/she feels would not have a safe anastomosis Patient life expectacny less than follow-up timeframe of study Pregnancy Patients currently enrolled in a study that competes for the same patient population

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>PSD Veritas Collagen Matrix Reinforcement Arm | Device: Staple line reinforcement<br>* Placement of reinforcement material on circular anastomotic staple line for prevention of leak during and post surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. |  | Discharge and 1 Month post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staple line reinforcement, Staple line buttress, Anastomotic reinforcement