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OpenTrials
Completed

NCT Number: NCT00559013

Peri-Strips Dry (PSD) 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahey Clinic, Burlington, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Staple Line Reinforcement

Device

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

Primary outcomes

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

    Time frame: Discharge and 1 Month post surgery

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Collaborators

  • Synovis Surgical Innovations

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 16, 2007
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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