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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

November 14, 2007
May 23, 2012
March 2007
December 2008   (final data collection date for primary outcome measure)
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 ]
Incidence of major colorectal related adverse events: leak, stricture and hemorrhage. [ Time Frame: Discharge and 1 Month post surgery ]
Complete list of historical versions of study NCT00559013 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Colorectal Cancer
Device: Staple line reinforcement
Placement of reinforcement material on circular anastomotic staple line for prevention of leak during and post surgery.
Active Comparator: 1
PSD Veritas Collagen Matrix Reinforcement Arm
Intervention: Device: Staple line reinforcement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00559013
CP1011, Rev C
No
Lesa Hobright-Turner, Director of Clinical Affairs, Synovis Surgical Innovations
Synovis Surgical Innovations
Not Provided
Principal Investigator: Richard Karulf, MD Colon & Rectal Surgery Associates
Synovis Surgical Innovations
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP