Hernia, Inguinal, Hernia, Ventral
Conditions
Keywords
hernia
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.
Interventions
DEVICEAbsorbaTack
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.
DEVICEProTack
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.
Sponsors
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | Discharge, Month 1, Month 6, Month 12 | 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 | One year | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Pre-op, Month 1, Month 6, 1 year | 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 | Discharge, 1 Month, 6 Month, 1 year | — |
Countries
United States
Participant flow
Recruitment details
Between November 4, 2008 and November 4, 2010, 117 subjects signed informed consent for the inguinal hernia arm of the study and 113 for the ventral arm. Of those subjects who consented, 106 and 110 were randomized to a treatment group (either AbsorbaTack™ or ProTack™) for inguinal and ventral hernia repair, respectively.
Participants by arm
| Arm | Count |
|---|---|
| Inguinal Arm - AbsorbaTack Inguinal hernia study arm with AbsorbaTack as treatment. | 52 |
| Inguinal Arm - ProTack Inguinal hernia study arm with ProTack as treatment. | 52 |
| Ventral Arm - Absorbatack Ventral hernia study arm with AbsorbaTack as treatment. | 56 |
| Ventral Arm - ProTack Ventral hernia study arm with ProTack as treatment. | 54 |
| Total | 214 |
Baseline characteristics
| Characteristic | Inguinal Arm - AbsorbaTack | Inguinal Arm - ProTack | Ventral Arm - Absorbatack | Ventral Arm - ProTack | Total |
|---|---|---|---|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 15.5 | 53.3 years STANDARD_DEVIATION 12.3 | 50.3 years STANDARD_DEVIATION 11.3 | 53.8 years STANDARD_DEVIATION 12.9 | 51.49 years STANDARD_DEVIATION 13.15 |
| Region of Enrollment France | 14 participants | 13 participants | 19 participants | 19 participants | 65 participants |
| Region of Enrollment Germany | 4 participants | 6 participants | 6 participants | 6 participants | 22 participants |
| Region of Enrollment United States | 34 participants | 33 participants | 31 participants | 29 participants | 127 participants |
| Sex: Female, Male Female | 1 Participants | 7 Participants | 20 Participants | 27 Participants | 55 Participants |
| Sex: Female, Male Male | 51 Participants | 45 Participants | 36 Participants | 27 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 53 | 20 / 51 | 24 / 55 | 33 / 54 |
| serious Total, serious adverse events | 6 / 53 | 6 / 51 | 8 / 55 | 9 / 54 |
Outcome results
Primary
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.
Time frame: Discharge, Month 1, Month 6, Month 12
Population: 1 patient in the Ventral Arm - AbsorbaTack had only pre-operative pain scores available so was unable to be included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inguinal Arm - AbsorbaTack | Postoperative Pain | Change from baseline - discharge | .8 units on a scale | Standard Deviation 2.8 |
| Inguinal Arm - AbsorbaTack | Postoperative Pain | Change from baseline - 1 month | -1.1 units on a scale | Standard Deviation 2.7 |
| Inguinal Arm - AbsorbaTack | Postoperative Pain | Change from baseline - 6 months | -1.8 units on a scale | Standard Deviation 2.4 |
| Inguinal Arm - AbsorbaTack | Postoperative Pain | Change from baseline - 1 year | -1.2 units on a scale | Standard Deviation 2.3 |
| Inguinal Arm - ProTack | Postoperative Pain | Change from baseline - 1 month | -.4 units on a scale | Standard Deviation 1.8 |
| Inguinal Arm - ProTack | Postoperative Pain | Change from baseline - 6 months | -.6 units on a scale | Standard Deviation 1.8 |
| Inguinal Arm - ProTack | Postoperative Pain | Change from baseline - 1 year | -.9 units on a scale | Standard Deviation 1.6 |
| Inguinal Arm - ProTack | Postoperative Pain | Change from baseline - discharge | 2.0 units on a scale | Standard Deviation 2.2 |
| Ventral Arm - Absorbatack | Postoperative Pain | Change from baseline - 6 months | -1.3 units on a scale | Standard Deviation 2.8 |
| Ventral Arm - Absorbatack | Postoperative Pain | Change from baseline - 1 month | -.7 units on a scale | Standard Deviation 3 |
| Ventral Arm - Absorbatack | Postoperative Pain | Change from baseline - 1 year | -1.8 units on a scale | Standard Deviation 2.7 |
| Ventral Arm - Absorbatack | Postoperative Pain | Change from baseline - discharge | 2.2 units on a scale | Standard Deviation 3.8 |
| Ventral Arm - ProTack | Postoperative Pain | Change from baseline - 1 year | -.8 units on a scale | Standard Deviation 1.8 |
| Ventral Arm - ProTack | Postoperative Pain | Change from baseline - 1 month | .5 units on a scale | Standard Deviation 1.9 |
| Ventral Arm - ProTack | Postoperative Pain | Change from baseline - discharge | 3.3 units on a scale | Standard Deviation 3.6 |
| Ventral Arm - ProTack | Postoperative Pain | Change from baseline - 6 months | -.6 units on a scale | Standard Deviation 1.7 |
Primary
Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events
Time frame: One year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inguinal Arm - AbsorbaTack | Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events | 7 participants |
| Inguinal Arm - ProTack | Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events | 8 participants |
| Ventral Arm - Absorbatack | Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events | 7 participants |
| Ventral Arm - ProTack | Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events | 8 participants |
Secondary
Hernia Recurrence
Time frame: Discharge, 1 Month, 6 Month, 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inguinal Arm - AbsorbaTack | Hernia Recurrence | 6 Month | 2 participants |
| Inguinal Arm - AbsorbaTack | Hernia Recurrence | Discharge | 0 participants |
| Inguinal Arm - AbsorbaTack | Hernia Recurrence | 1 Year | 0 participants |
| Inguinal Arm - AbsorbaTack | Hernia Recurrence | 1 Month | 0 participants |
| Inguinal Arm - ProTack | Hernia Recurrence | Discharge | 1 participants |
| Inguinal Arm - ProTack | Hernia Recurrence | 6 Month | 1 participants |
| Inguinal Arm - ProTack | Hernia Recurrence | 1 Month | 1 participants |
| Inguinal Arm - ProTack | Hernia Recurrence | 1 Year | 1 participants |
| Ventral Arm - Absorbatack | Hernia Recurrence | 1 Month | 1 participants |
| Ventral Arm - Absorbatack | Hernia Recurrence | Discharge | 0 participants |
| Ventral Arm - Absorbatack | Hernia Recurrence | 6 Month | 3 participants |
| Ventral Arm - Absorbatack | Hernia Recurrence | 1 Year | 1 participants |
| Ventral Arm - ProTack | Hernia Recurrence | Discharge | 0 participants |
| Ventral Arm - ProTack | Hernia Recurrence | 1 Month | 2 participants |
| Ventral Arm - ProTack | Hernia Recurrence | 1 Year | 0 participants |
| Ventral Arm - ProTack | Hernia Recurrence | 6 Month | 0 participants |
Secondary
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.
Time frame: Pre-op, Month 1, Month 6, 1 year
Population: Participant # above reflects those at pre-op. Arms ended study with 34, 39, 36 and 39 subjects, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inguinal Arm - AbsorbaTack | Quality of Life | 1 year | 55.8 units on a scale | Standard Deviation 7.4 |
| Inguinal Arm - AbsorbaTack | Quality of Life | Pre-Op | 48.8 units on a scale | Standard Deviation 8.6 |
| Inguinal Arm - AbsorbaTack | Quality of Life | 1 Month | 49.1 units on a scale | Standard Deviation 7.9 |
| Inguinal Arm - AbsorbaTack | Quality of Life | 6 Month | 55.3 units on a scale | Standard Deviation 6.6 |
| Inguinal Arm - ProTack | Quality of Life | 6 Month | 54.4 units on a scale | Standard Deviation 6.3 |
| Inguinal Arm - ProTack | Quality of Life | 1 year | 53.8 units on a scale | Standard Deviation 6 |
| Inguinal Arm - ProTack | Quality of Life | Pre-Op | 50.6 units on a scale | Standard Deviation 8.1 |
| Inguinal Arm - ProTack | Quality of Life | 1 Month | 50.2 units on a scale | Standard Deviation 7 |
| Ventral Arm - Absorbatack | Quality of Life | 6 Month | 51.6 units on a scale | Standard Deviation 9.4 |
| Ventral Arm - Absorbatack | Quality of Life | 1 year | 52.0 units on a scale | Standard Deviation 8.1 |
| Ventral Arm - Absorbatack | Quality of Life | 1 Month | 45.4 units on a scale | Standard Deviation 9.5 |
| Ventral Arm - Absorbatack | Quality of Life | Pre-Op | 46.1 units on a scale | Standard Deviation 9.3 |
| Ventral Arm - ProTack | Quality of Life | 1 year | 53.3 units on a scale | Standard Deviation 6.6 |
| Ventral Arm - ProTack | Quality of Life | 6 Month | 51.1 units on a scale | Standard Deviation 7.6 |
| Ventral Arm - ProTack | Quality of Life | Pre-Op | 49.0 units on a scale | Standard Deviation 9.1 |
| Ventral Arm - ProTack | Quality of Life | 1 Month | 45.2 units on a scale | Standard Deviation 9 |