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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: Staple line reinforcement

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
  • Minnesota
    • St. Paul, Minnesota, United States, 55105
      • Colon & Rectal Surgery Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Synovis Surgical Innovations
• Investigators: Principal Investigator: Richard Karulf, MD, Colon & Rectal Surgery Associates

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: November 14, 2007
• First Submitted That Met QC Criteria: November 15, 2007
• First Posted (Estimate): November 16, 2007

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Staple line reinforcement; Staple line buttress; Anastomotic reinforcement
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CP1011, Rev C