Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix (RESULTS)

This study has been completed.
Sponsor:
Information provided by:
Synovis Surgical Innovations
ClinicalTrials.gov Identifier:
NCT00566943
First received: November 29, 2007
Last updated: May 23, 2012
Last verified: July 2011
  Purpose

The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.


Condition Intervention Phase
Obesity
Device: PSD Veritas Collagen Matrix
Procedure: Roux-en-Y gastric by-pass surgery with no buttress
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Synovis Life Technologies, Inc., Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement. The RESULTS Trial

Resource links provided by NLM:


Further study details as provided by Synovis Surgical Innovations:

Primary Outcome Measures:
  • Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups. [ Time Frame: Discharge/ 30 days Linear Discharge/30/90 days Circular ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Discharge/30 Linear Discharge/30/90 days Circular ] [ Designated as safety issue: Yes ]
    Leak as determined by a comparison of control group to PSD Veritas group in both linear and circular arms.


Secondary Outcome Measures:
  • Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group [ Time Frame: Discharge and 30 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: Discharge, 30 and 90 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 101
Study Start Date: March 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control

Patients who have laparoscopic Roux-en-Y gastric by-pass surgery without staple line buttress material. No buttress material will be used on staple lines including stomach/pouch, anastomostic junctions, (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine). intestine or mesentery.

Patients who have laparoscopic Roux-en-Y gastric by-pass surgery without buttress at the GJ anastomosis. Linear buttress at the stomach/pouch staple line is required.

Procedure: Roux-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.
Active Comparator: PSD Veritas

Linear Peri-Strips Dry Veritas Group: Patients who have laparoscopic Roux-en-Y gastric by-pass surgery with PSD Veritas used as a staple line buttress at the stomach/pouch.

In addition to buttress of the stomach/pouch, patients may have PSD Veritas linear buttress at any of the following staple lines: intestine, mesentery, or anastomosis junction (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine).

Circular Peri-Strips Dry Veritas Group: Patients who have laparoscopic Roux-en-Y gastric by-pass surgery with PSD Veritas circular buttress used as a staple line buttress at the GJ anastomosis. Linear buttress at the stomach/pouch is required.

Device: PSD 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566943

Locations
United States, Missouri
University of Missouri-Columbia
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
Synovis Surgical Innovations
Investigators
Principal Investigator: Roger De La Torre, MD Division of General Surgery University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Lesa Hobright-Turner, Director of Clinical Affairs, Synovis Surgical Innovations
ClinicalTrials.gov Identifier: NCT00566943     History of Changes
Other Study ID Numbers: CP1007, Rev C
Study First Received: November 29, 2007
Results First Received: December 18, 2009
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Synovis Surgical Innovations:
Staple Line Reinforcement, Buttress

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014