Inguinal Hernia
Conditions
Keywords
Inguinal hernia, Chronic pain, Mesh, Lichtenstein hernioplasty
Brief summary
The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair.
Detailed description
The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. The patients are randomized into two study gropus receiving mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1 month, 6 months and 3 years after the operation.
Interventions
DEVICEOptilene LP mesh
Lichtenstein hernioplasty
DEVICEUltrapro mesh
Lichtenstein hernioplasty
Sponsors
Tartu University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age ≥18 years * unilateral primary reducible inguinal hernia * elective operation * consent to participate in the study.
Exclusion criteria
* age \<18 years * irreducible * strangulated * recurrent hernia * inability to understand the questionnaire * unwillingness to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pain | 6-month follow-up | On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pain | 3-year follow-up | On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise |
| Foreign Body Feeling | 6-month follow-up | The question about foreign body feeling was a yes-or-no question |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OM Group Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty | 63 |
| UM Group Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty | 65 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 1 |
| Overall Study | Lost to Follow-up | 3 | 7 |
| Overall Study | Recurrence | 1 | 0 |
Baseline characteristics
| Characteristic | OM Group | UM Group | Total |
|---|---|---|---|
| Age, Customized >=18 years | 63 participants | 65 participants | 128 participants |
| Elective operation | 63 participants | 65 participants | 128 participants |
| Primary inguinal hernia | 63 participants | 65 participants | 128 participants |
| Reducible inguinal hernia | 63 participants | 65 participants | 128 participants |
| Sex/Gender, Customized Female | 3 participants | 10 participants | 13 participants |
| Sex/Gender, Customized Male | 60 participants | 55 participants | 115 participants |
| Unilateral inguinal hernia | 63 participants | 65 participants | 128 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 65 |
| other Total, other adverse events | 10 / 63 | 10 / 65 |
| serious Total, serious adverse events | 0 / 63 | 0 / 65 |
Outcome results
Primary
Chronic Pain
On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
Time frame: 6-month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OM Group | Chronic Pain | 34.3 percentage of patients with pain |
| UM Group | Chronic Pain | 46.3 percentage of patients with pain |
Secondary
Chronic Pain
On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
Time frame: 3-year follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OM Group | Chronic Pain | 15.9 percentage of patients with pain |
| UM Group | Chronic Pain | 33.9 percentage of patients with pain |
Secondary
Foreign Body Feeling
The question about foreign body feeling was a yes-or-no question
Time frame: 6-month follow-up
Population: Drop-outs at 6-month follow-up (3+6) not included
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OM Group | Foreign Body Feeling | 31.3 percentage of patients with foreign body |
| UM Group | Foreign Body Feeling | 47.8 percentage of patients with foreign body |