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

This study has been completed.
Sponsor:
Information provided by:
Synovis Surgical Innovations
ClinicalTrials.gov Identifier:
NCT00559013
First received: November 14, 2007
Last updated: May 23, 2012
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Colorectal Cancer
 Device: Staple line reinforcement
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Synovis Surgical Innovations:

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

Enrollment: 38
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Synovis Surgical Innovations
Investigators
Principal Investigator: Richard Karulf, MD Colon & Rectal Surgery Associates
  More Information

No publications provided

Responsible Party: Lesa Hobright-Turner, Director of Clinical Affairs, Synovis Surgical Innovations
ClinicalTrials.gov Identifier: NCT00559013     History of Changes
Other Study ID Numbers: CP1011, Rev C
Study First Received: November 14, 2007
Results First Received: December 15, 2009
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Synovis Surgical Innovations:
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

ClinicalTrials.gov processed this record on June 17, 2013