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

Tracking Information

First Received Date ^ICMJE

November 14, 2007

Last Updated Date

May 23, 2012

Start Date ^ICMJE

March 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Incidence of major colorectal related adverse events: leak, stricture and hemorrhage. [ Time Frame: Discharge and 1 Month post surgery ]

Change History

Complete list of historical versions of study NCT00559013 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

Device: Staple line reinforcement

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

Study Arm (s)

Active Comparator: 1

PSD Veritas Collagen Matrix Reinforcement Arm

Intervention: Device: Staple line reinforcement

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00559013

Other Study ID Numbers ^ICMJE

CP1011, Rev C

Has Data Monitoring Committee

Responsible Party

Lesa Hobright-Turner, Director of Clinical Affairs, Synovis Surgical Innovations

Study Sponsor ^ICMJE

Synovis Surgical Innovations

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Richard Karulf, MD

Colon & Rectal Surgery Associates

Information Provided By

Synovis Surgical Innovations

Verification Date

July 2011

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

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