Colorectal Cancer
Conditions
Keywords
Staple line reinforcement, Staple line buttress, Anastomotic reinforcement
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.
Detailed description
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.
Interventions
Placement of reinforcement material on circular anastomotic staple line for prevention of leak during and post surgery.
Sponsors
Synovis Surgical Innovations
Baxter Healthcare Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. | Discharge and 1 Month post surgery |
Countries
United States
Participant flow
Recruitment details
38 subjects were recruited from two principal investigators and their respective surgical hospitals in the US from approximately February 2007 through October 2008.
Pre-assignment details
Subjects were excluded from the study if the met any of the exclusion criteria including having a a body mass index greater than 35, a history of Chron's Disease, or stage IV cancer. There was no washout, run-in or transition period to this study.
Participants by arm
| Arm | Count |
|---|---|
| PSD Veritas Collagen Matrix Reinforcement Arm Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | PSD Veritas Collagen Matrix Reinforcement Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 57.26 years STANDARD_DEVIATION 11.44 |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 38 |
| serious Total, serious adverse events | 3 / 38 |
Outcome results
Primary
Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.
Time frame: Discharge and 1 Month post surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSD Veritas Collagen Matrix Reinforcement Arm | Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. | 4 Participants |