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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Device: Staple line reinforcement

• Registration Number: NCT00559013
• Lead Sponsor: Baxter Healthcare Corporation

Brief Summary

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

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 Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-12-15
• Results First Submitted QC: 2012-05-23
• Results First Posted: 2012-05-24
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Staple line reinforcement	PSD Veritas Collagen Matrix Reinforcement Arm

Primary Outcome Measures

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

Trial Locations

Locations (2)

Colon & Rectal Surgery Associates; 🇺🇸 St. Paul, Minnesota, United States

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States