Obesity
Conditions
Keywords
Staple Line Reinforcement, Buttress
Brief summary
The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.
Detailed description
The purpose of the study is to verify the performance of PSD Veritas in providing staple line protection for surgical procedures that buttress the stomach and other staple lines during roux-en-Y surgery. The study is designed as two separate patient groups. One will enroll patients into a group where linear staple lines are buttressed at the stomach. The second portion of the trial will enroll patients into a group where the circular staple line at the GJ and linear staple lines at the stomach are buttressed with PSD Veritas.
Interventions
DEVICEPSD Veritas Collagen Matrix
Roux-en-Y gastric by-pass surgery. Surgeon creates a small pouch from the stomach and then by-passes a large portion of the small intestine. The body cannot absorb as many calories or nutrients thus resulting in weight loss.
PROCEDURERoux-en-Y gastric by-pass surgery with no buttress
Patients who have laparoscopic Roux-en-Y gastric by-pass surgery without staple line buttress material. No buttress material will be used on staple line including stomach/pouch, anastomostic junctions, (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine intestine to mesentery.
Sponsors
Synovis Surgical Innovations
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient 18 years or older * Patient willing to comply with follow-up evaluations * Patient understands nature of procedure and provides informed consent * Female patient has stated that she is not pregnant and will not become pregnant during trial.
Exclusion criteria
* Patient currently enrolled in another device/drug trial that competes for same patient population * Patient with short life expectancy (12 months) wherever the cause is not linked to obesity * BMI is equal or less than 40 and equal to or less than 65 * Patient does not meet National Institute of Health (NIH) criteria for gastric by-pass surgery * Patient has had previous buttress or other material used in the staple lines that will affect the outcome of this trial. * Patient has known sensitivity to bovine material
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups. | Discharge/ 30 days Linear Discharge/30/90 days Circular | Adverse events as measured through hospital discharge and 30 days post-discharge in both the linear and circular arms of the study. |
| Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group. | Discharge/30 Linear Discharge/30/90 days Circular | Leak as determined by a comparison of control group to PSD Veritas group in both linear and circular arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group | Discharge and 30 days | Comparison of number of subjects who required use of Endoclips or sutures for bleeding in Control group versus the number of subjects who required use of Endoclips or sutures for bleeding in PSD Veritas group in the linear arm of the study. |
| Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas. | Discharge, 30 and 90 days | Stricture requiring intervention comparison between control group and PSD Vertas group. Bleeding assessment comparison of control group to PSD Veritas Group. These results will combine both stricture and bleeding since this was how it was entered in to the database. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at one surgical site in the US from approximately March 2006 through May 2008. One hundred one subjects were entered into the study.
Pre-assignment details
Subjects were excluded from the study if their Body Mass Index was less than or equal to 35 or greater than or equal to 65. Subjects could not have a life expectancy of less than 12 months nor a known sensitivity to bovine material.
Participants by arm
| Arm | Count |
|---|---|
| Control control arm where no buttress is used on stomach or GJ anastomosis staple lines. | 52 |
| PSD Veritas PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas. | 49 |
| Total | 101 |
Baseline characteristics
| Characteristic | PSD Veritas | Total | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 101 Participants | 52 Participants |
| Age, Continuous | 46.61 years STANDARD_DEVIATION 10.2 | 45.3 years STANDARD_DEVIATION 9.69 | 42.93 years STANDARD_DEVIATION 9.18 |
| Region of Enrollment United States | 49 participants | 101 participants | 52 participants |
| Sex: Female, Male Female | 40 Participants | 87 Participants | 47 Participants |
| Sex: Female, Male Male | 9 Participants | 14 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 49 |
| serious Total, serious adverse events | 0 / 52 | 0 / 49 |
Outcome results
Primary
Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group.
Leak as determined by a comparison of control group to PSD Veritas group in both linear and circular arms.
Time frame: Discharge/30 Linear Discharge/30/90 days Circular
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Number of Subjects in Control Group | Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group. | 0 Participants |
| Number of Subjects in PSD Veritas Group | Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group. | 2 Participants |
Primary
Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups.
Adverse events as measured through hospital discharge and 30 days post-discharge in both the linear and circular arms of the study.
Time frame: Discharge/ 30 days Linear Discharge/30/90 days Circular
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Number of Subjects in Control Group | Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups. | 3 Participants |
| Number of Subjects in PSD Veritas Group | Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups. | 2 Participants |
Secondary
Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group
Comparison of number of subjects who required use of Endoclips or sutures for bleeding in Control group versus the number of subjects who required use of Endoclips or sutures for bleeding in PSD Veritas group in the linear arm of the study.
Time frame: Discharge and 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Number of Subjects in Control Group | Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group | 10 Participants |
| Number of Subjects in PSD Veritas Group | Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group | 6 Participants |
Secondary
Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas.
Stricture requiring intervention comparison between control group and PSD Vertas group. Bleeding assessment comparison of control group to PSD Veritas Group. These results will combine both stricture and bleeding since this was how it was entered in to the database.
Time frame: Discharge, 30 and 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Number of Subjects in Control Group | Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas. | 1 participants |
| Number of Subjects in PSD Veritas Group | Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas. | 3 participants |