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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559013
• Other study ID #: CP1011, Rev C
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2007
• Last updated: May 23, 2012
• Start date: March 2007
• Est. completion date: December 2008

Study information

• Verified date: July 2011
• Source: Synovis Surgical Innovations
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Device:
• Staple line reinforcement
Placement of reinforcement material on circular anastomotic staple line for prevention of leak during and post surgery.

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts
United States	Colon & Rectal Surgery Associates	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Synovis Surgical Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.		Discharge and 1 Month post surgery	Yes