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

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ClinicalTrials.gov Identifier: NCT00559013
Recruitment Status : Completed
First Posted : November 16, 2007
Results First Posted : May 24, 2012
Last Update Posted : May 10, 2017
Sponsor:
Collaborator:
Synovis Surgical Innovations
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Device: Staple line reinforcement Not Applicable

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  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Study Start Date : March 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

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.




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559013


Locations
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Minnesota
Colon & Rectal Surgery Associates
St. Paul, Minnesota, United States, 55105
Sponsors and Collaborators
Baxter Healthcare Corporation
Synovis Surgical Innovations
Investigators
Principal Investigator: Richard Karulf, MD Colon & Rectal Surgery Associates

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00559013     History of Changes
Other Study ID Numbers: CP1011, Rev C
First Posted: November 16, 2007    Key Record Dates
Results First Posted: May 24, 2012
Last Update Posted: May 10, 2017
Last Verified: April 2017

Keywords provided by Baxter Healthcare Corporation:
Staple line reinforcement
Staple line buttress
Anastomotic reinforcement

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases