Back to resultsAbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
Primary Purpose
Hernia, Inguinal, Hernia, Ventral
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AbsorbaTack
ProTack
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Inguinal focused on measuring hernia
Eligibility Criteria
Inclusion Criteria:
- Ability and willingness to provide written informed consent and comply with the schedule of protocol assessments
- Age > 18 years
- Subjects undergoing laparoscopic hernia repair with Parietex or Parietex Composite reinforcements depending on indication and fixation of reinforcements with helical tackers (ProTack, Covidien) or absorbable tacks (AbsorbaTack, Covidien) in accordance with recommendations for use
Exclusion Criteria:
- Pregnancy
- Patients considered to have greater than reasonable surgical risk associated with general anesthesia and laparoscopic hernia repair
- Known active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics within 30 days prior to screening
- History of alcohol or drug abuse within 6 months prior to screening
- History of chronic pain condition requiring more than 30 days of medical management
- Use of an additional nonresorbable means of fixation (inguinal)
- Patients considered not able to comply with the protocol and follow up schedule
- ASA grade of 4 or above
Sites / Locations
- University Hospitals at Case Medical Center
- Greenville Hospital System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Postoperative Pain
Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm.
Scale is 0 - 10 with 0 being "no pain" and 10 being "worst pain imaginable".
Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events
Secondary Outcome Measures
Quality of Life
Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life.
The Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Hernia Recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00749268
Brief Title
AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
Official Title
Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair: A Prospective, Randomized Comparison to Evaluate the Incidence of Post-operative Pain Associated With Absorbable Fixation (AbsorbaTack) vs Conventional Fixation (ProTack) Following Laparoscopic Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent methods of mesh fixation in inguinal and ventral hernia repair.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal, Hernia, Ventral
Keywords
hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
AbsorbaTack
Intervention Description
Comparison of different devices for mesh fixation. This intervention arm has absorbable tacks as the method of hernia mesh fixation. Application is during hernia repair and tacks will essentially absorb within the body after 1 year.
Intervention Type
Device
Intervention Name(s)
ProTack
Intervention Description
Comparison of different devices for mesh fixation. This intervention is a permanent tack for hernia mesh fixation. Application is during hernia repair and the tacks will remain in the body.
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm.
Scale is 0 - 10 with 0 being "no pain" and 10 being "worst pain imaginable".
Time Frame
Discharge, Month 1, Month 6, Month 12
Title
Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events
Time Frame
One year
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life.
The Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time Frame
Pre-op, Month 1, Month 6, 1 year
Title
Hernia Recurrence
Time Frame
Discharge, 1 Month, 6 Month, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability and willingness to provide written informed consent and comply with the schedule of protocol assessments
Age > 18 years
Subjects undergoing laparoscopic hernia repair with Parietex or Parietex Composite reinforcements depending on indication and fixation of reinforcements with helical tackers (ProTack, Covidien) or absorbable tacks (AbsorbaTack, Covidien) in accordance with recommendations for use
Exclusion Criteria:
Pregnancy
Patients considered to have greater than reasonable surgical risk associated with general anesthesia and laparoscopic hernia repair
Known active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics within 30 days prior to screening
History of alcohol or drug abuse within 6 months prior to screening
History of chronic pain condition requiring more than 30 days of medical management
Use of an additional nonresorbable means of fixation (inguinal)
Patients considered not able to comply with the protocol and follow up schedule
ASA grade of 4 or above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Rosen
Organizational Affiliation
Case Medical Center, University Hospitals of Cleveland, Cleveland, OH, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals at Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44194
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
12. IPD Sharing Statement
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AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
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