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

NCT00559013 | Completed Results

• 1 other identifier: CP1011, Rev C
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer

Keywords

Staple line reinforcement; Staple line buttress; Anastomotic reinforcement

Outcome Measures

Primary Outcomes (1)

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

  Discharge and 1 Month post surgery

Study Arms (1)

1

ACTIVE COMPARATOR

PSD Veritas Collagen Matrix Reinforcement Arm

Device: Staple line reinforcement

Interventions

Staple line reinforcement DEVICE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• Synovis Surgical Innovations: collaborator

Study Sites (2)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Colon & Rectal Surgery Associates

Saint Paul, Minnesota, 55105, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Lesa Hobright-Turner, Director of Clinical Affairs
• Organization: Synovis

lesa.hobrightturner@synovissurgical.com

651-796-7506

Study Officials

• Richard Karulf, MD

  Colon & Rectal Surgery Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 10, 2017
• Results First Posted: May 24, 2012

Record last verified: 2017-04

Locations

US (2)