N/A
N=38
Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00559013 ↗Enrolled (actual)
38
Serious AEs
7.9%
Results posted
May 2012
Primary outcome: Primary: Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Staple line reinforcement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baxter Healthcare Corporation
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. |
4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00559013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.