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


Phase 4
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Discharge and 1 Month post surgery

Safety Issue:

Yes

Principal Investigator

Richard Karulf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Colon & Rectal Surgery Associates

Authority:

United States: Institutional Review Board

Study ID:

CP1011, Rev C

NCT ID:

NCT00559013

Start Date:

March 2007

Completion Date:

December 2008

Related Keywords:

  • Colorectal Cancer
  • Staple line reinforcement
  • Staple line buttress
  • Anastomotic reinforcement
  • Colorectal Neoplasms

Name

Location

Lahey ClinicBurlington, Massachusetts  01805
Colon & Rectal Surgery AssociatesSt. Paul, Minnesota  55105