Clinical trial · Interventional
Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
NCT00559013CI-TRIAL-00027508completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Staple line reinforcement | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- PSD Veritas Collagen Matrix Reinforcement Arm
- interventionNames
- Device: Staple line reinforcement
Primary outcomes (1)
- measure
- Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.
- timeFrame
- Discharge and 1 Month post surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.