Inguinal Hernia
Conditions
Keywords
pain
Brief summary
The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.
Detailed description
Pain is a frequent problem after open inguinal hernia repair. The most frequent operative technique for inguinal hernia repair in adults is the Lichtenstein mesh repair, where a polypropylene mesh is sutured to the tissue in the inguinal region. We therefore want to evaluate the effect of suture for mesh fixation on the occurrence of chronic pain 12 months after operation.
Interventions
PROCEDUREsuture
suture for mesh fixation
PROCEDUREno suture
no suture for mesh fixation, because we use a self-adhesive mesh
Sponsors
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Frederikshavn Hospital
Nyborg Hospital
Jacob Rosenberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Healthy males 18-80 years * Primary inguinal unilateral hernia
Exclusion criteria
* Recurrent hernia * Bilateral, scrotal or femoral hernia * BMI above 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain, Numbness and Discomfort in the Groin | 12 months after surgery | The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | 12 months after surgery | recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| no Suture self-adhesive mesh, i.e. no suture for mesh fixation
no suture: no suture for mesh fixation, because we use a self-adhesive mesh | 163 |
| Suture Suture for mesh fixation
suture: suture for mesh fixation | 171 |
| Total | 334 |
Baseline characteristics
| Characteristic | no Suture | Suture | Total |
|---|---|---|---|
| Age, Continuous | 56.8 years | 59.9 years | 58.0 years |
| Region of Enrollment Denmark | 163 participants | 171 participants | 334 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 163 Participants | 171 Participants | 334 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 163 | 0 / 171 |
| serious Total, serious adverse events | 0 / 163 | 0 / 171 |
Outcome results
Primary
Pain, Numbness and Discomfort in the Groin
The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.
Time frame: 12 months after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| no Suture | Pain, Numbness and Discomfort in the Groin | 28 participants |
| Suture | Pain, Numbness and Discomfort in the Groin | 34 participants |
Secondary
Recurrence
recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia.
Time frame: 12 months after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| no Suture | Recurrence | 2 participants |
| Suture | Recurrence | 2 participants |