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

Baxter

Status: Completed

Conditions: Colorectal Cancer

Treatments: Device: Staple line reinforcement

Study type: Interventional

Funder types: Industry

Identifiers

NCT00559013

CP1011, Rev C

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

1

Active Comparator group

Description:

PSD Veritas Collagen Matrix Reinforcement Arm

Treatment:

Device: Staple line reinforcement