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

Completed · Not applicable

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT00559013

Run by

Baxter Healthcare Corporation

People needed

38

Starts

2007-03-01

Expected to finish

2008-12-01

Last updated by the study team

2017-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lahey Clinic — Burlington, Massachusetts, United States
• Colon & Rectal Surgery Associates — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.