Hernia, Inguinal
Conditions
Keywords
Uncomplicated primary inguinal hernias
Brief summary
The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.
Detailed description
* Patients in ProGrip group will be treated with self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation. * Patients in Lichtenstein group will be treated with lightweight Polypropylene meshes requiring fixation by sutures. * Study participation will start at signature of informed consent and each patient will be assessed before surgery. A close follow-up will be performed: 7 days (questionnaires and phone call), 1 month (clinical visit), 3 months (questionnaires and phone call), and final evaluation at 12 months (clinical visit) after surgery, which will end the participation to the study. * 600 adult males divided in 2 groups requiring primary uncomplicated elective inguinal hernia mesh repair will be included in the study. Patients will be stratified by center.
Interventions
DEVICEParietex Progrip
Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
DEVICELow weight polypropylene mesh
Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
Sponsors
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
31 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* All male patients at participating centers with a primary, uncomplicated inguinal hernia. * Collar of the defect ≤ 4 cm * Signed informed consent
Exclusion criteria
* 30 years ≥ Age ≥ 75 years * Emergency procedure * Inclusion in other trials * Bilateral inguinal hernia * Recurrence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) | M3, M12 after surgery | Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home. |
| Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS) | M3, M12 after surgery | Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Complications and Hernia Recurrences | M12 after surgery | — |
| Foreign Body Sensation | M1, M3, M12 months after surgery | Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. |
| Other Post-operative Complications | M12 after surgery | — |
| Return to Work and to Normal Daily Activities | Effective date | — |
| Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score | 3 months after surgery | Chronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home. |
Countries
Belgium, Germany, Netherlands, Sweden, United Kingdom
Participant flow
Recruitment details
Study period: 42 months First patient in: 13 October 2008 Last patient in: 27 April 2011 Last Patient visit: 8 May 2012 Follow-up duration: 1 year
Participants by arm
| Arm | Count |
|---|---|
| Progrip Group Parietex ProGrip
Parietex Progrip : Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation. | 304 |
| Lichtenstein Group Low weight polypropylene mesh
Low weight polypropylene mesh : Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures | 299 |
| Total | 603 |
Baseline characteristics
| Characteristic | Progrip Group | Lichtenstein Group | Total |
|---|---|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 12.1 | 57.2 years STANDARD_DEVIATION 10.9 | 57.2 years STANDARD_DEVIATION 11.5 |
| Gender Female | 0 Participants | 0 Participants | 0 Participants |
| Gender Male | 304 Participants | 299 Participants | 603 Participants |
| Region of Enrollment Belgium | 13 participants | 12 participants | 25 participants |
| Region of Enrollment Germany | 54 participants | 53 participants | 107 participants |
| Region of Enrollment Netherlands | 58 participants | 59 participants | 117 participants |
| Region of Enrollment Sweden | 87 participants | 86 participants | 173 participants |
| Region of Enrollment United Kingdom | 92 participants | 89 participants | 181 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 304 | 29 / 299 |
| serious Total, serious adverse events | 18 / 304 | 21 / 299 |
Outcome results
Primary
Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)
Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known).
Time frame: M3, M12 after surgery
Population: The analysis were performed on an As Treated population (AT), with a 5% significance level.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progrip Group | Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS) | Surgical Pain - 3 months | 6.62 units on a scale | Standard Deviation 15.42 |
| Progrip Group | Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS) | Surgical Pain - 12 months | 5.51 units on a scale | Standard Deviation 15.12 |
| Lichtenstein Group | Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS) | Surgical Pain - 3 months | 7.85 units on a scale | Standard Deviation 15.52 |
| Lichtenstein Group | Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS) | Surgical Pain - 12 months | 4.37 units on a scale | Standard Deviation 9.77 |
Primary
Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)
Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.
Time frame: M3, M12 after surgery
Population: The analysis were performed on an As Treated (AT)population, with a 5% significance level.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progrip Group | Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) | VAS - 3 months | 7.48 units on a scale | Standard Deviation 15.82 |
| Progrip Group | Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) | VAS - 12 months | 4.62 units on a scale | Standard Deviation 10.81 |
| Lichtenstein Group | Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) | VAS - 3 months | 6.76 units on a scale | Standard Deviation 17.05 |
| Lichtenstein Group | Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) | VAS - 12 months | 5.27 units on a scale | Standard Deviation 13.27 |
Secondary
Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score
Chronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.
Time frame: 3 months after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progrip Group | Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score | 9 participants |
| Lichtenstein Group | Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score | 12 participants |
Secondary
Foreign Body Sensation
Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing.
Time frame: M1, M3, M12 months after surgery
Population: The analysis were performed on an As Treated population, with a 5% significance level.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Progrip Group | Foreign Body Sensation | FBS at Rest - M1 (Answer : No) | 159 participants |
| Progrip Group | Foreign Body Sensation | FBS Normal Activities - M1 (Answer: No) | 139 participants |
| Progrip Group | Foreign Body Sensation | FBS Doing exercise - M1 (Answer : No) | 121 participants |
| Progrip Group | Foreign Body Sensation | FBS General Feeling - M1 (Answer : No) | 144 participants |
| Progrip Group | Foreign Body Sensation | FBS at Rest - M3 (Answer : No) | 186 participants |
| Progrip Group | Foreign Body Sensation | FBS Normal Activities - M3 (Answer: No) | 166 participants |
| Progrip Group | Foreign Body Sensation | FBS Doing exercise - M3 (Answer : No) | 140 participants |
| Progrip Group | Foreign Body Sensation | FBS General feeling - M3 (Answer : No) | 172 participants |
| Progrip Group | Foreign Body Sensation | FBS at Rest - M12 (Answer : No) | 178 participants |
| Progrip Group | Foreign Body Sensation | FBS Normal Activities - M12 (Answer: No) | 169 participants |
| Progrip Group | Foreign Body Sensation | FBS Doing exercise - M12 (Answer : No) | 171 participants |
| Progrip Group | Foreign Body Sensation | FBS General Feeling - M12 (Answer : No) | 176 participants |
| Lichtenstein Group | Foreign Body Sensation | FBS Doing exercise - M12 (Answer : No) | 165 participants |
| Lichtenstein Group | Foreign Body Sensation | FBS at Rest - M1 (Answer : No) | 173 participants |
| Lichtenstein Group | Foreign Body Sensation | FBS Doing exercise - M3 (Answer : No) | 155 participants |
| Lichtenstein Group | Foreign Body Sensation | FBS Normal Activities - M1 (Answer: No) | 148 participants |
| Lichtenstein Group | Foreign Body Sensation | FBS Normal Activities - M12 (Answer: No) | 197 participants |
| Lichtenstein Group | Foreign Body Sensation | FBS Doing exercise - M1 (Answer : No) | 128 participants |
| Lichtenstein Group | Foreign Body Sensation | FBS General feeling - M3 (Answer : No) | 189 participants |
| Lichtenstein Group | Foreign Body Sensation | FBS General Feeling - M1 (Answer : No) | 151 participants |
| Lichtenstein Group | Foreign Body Sensation | FBS General Feeling - M12 (Answer : No) | 199 participants |
| Lichtenstein Group | Foreign Body Sensation | FBS at Rest - M3 (Answer : No) | 198 participants |
| Lichtenstein Group | Foreign Body Sensation | FBS at Rest - M12 (Answer : No) | 196 participants |
| Lichtenstein Group | Foreign Body Sensation | FBS Normal Activities - M3 (Answer: No) | 177 participants |
Secondary
Other Post-operative Complications
Time frame: M12 after surgery
Population: As Treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progrip Group | Other Post-operative Complications | 23 participants |
| Lichtenstein Group | Other Post-operative Complications | 29 participants |
Secondary
Return to Work and to Normal Daily Activities
Time frame: Effective date
Population: The analysis were performed on an As Treated (AT) population, with a 5% significance level.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progrip Group | Return to Work and to Normal Daily Activities | Return to work | 14.61 days | Standard Error 11.61 |
| Progrip Group | Return to Work and to Normal Daily Activities | Return to daily activities | 7.99 days | Standard Error 8.78 |
| Lichtenstein Group | Return to Work and to Normal Daily Activities | Return to work | 14.79 days | Standard Error 11.51 |
| Lichtenstein Group | Return to Work and to Normal Daily Activities | Return to daily activities | 8.426 days | Standard Error 8.145 |
Secondary
Wound Complications and Hernia Recurrences
Time frame: M12 after surgery
Population: The analysis were performed on an As Treated (AT) population, with a 5% significance level.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Progrip Group | Wound Complications and Hernia Recurrences | Hematoma | 13 participants |
| Progrip Group | Wound Complications and Hernia Recurrences | Recurrence | 4 participants |
| Progrip Group | Wound Complications and Hernia Recurrences | Site Surgical Infection | 9 participants |
| Progrip Group | Wound Complications and Hernia Recurrences | Seroma | 4 participants |
| Lichtenstein Group | Wound Complications and Hernia Recurrences | Site Surgical Infection | 14 participants |
| Lichtenstein Group | Wound Complications and Hernia Recurrences | Hematoma | 5 participants |
| Lichtenstein Group | Wound Complications and Hernia Recurrences | Seroma | 6 participants |
| Lichtenstein Group | Wound Complications and Hernia Recurrences | Recurrence | 8 participants |