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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Staple line reinforcement
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Staple line reinforcement, Staple line buttress, Anastomotic reinforcement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lahey Clinic
  • Colon & Rectal Surgery Associates

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

PSD Veritas Collagen Matrix Reinforcement Arm

Outcomes

Primary Outcome Measures

Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.

Secondary Outcome Measures

Full Information

First Posted
November 14, 2007
Last Updated
April 4, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Synovis Surgical Innovations
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1. Study Identification

Unique Protocol Identification Number
NCT00559013
Brief Title
Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Official Title
Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Synovis Surgical Innovations

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Staple line reinforcement, Staple line buttress, Anastomotic reinforcement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
PSD Veritas Collagen Matrix Reinforcement Arm
Intervention Type
Device
Intervention Name(s)
Staple line reinforcement
Intervention Description
Placement of reinforcement material on circular anastomotic staple line for prevention of leak during and post surgery.
Primary Outcome Measure Information:
Title
Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.
Time Frame
Discharge and 1 Month post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Karulf, MD
Organizational Affiliation
Colon & Rectal Surgery Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Colon & Rectal Surgery Associates
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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