Inguinal Hernia
Conditions
Keywords
inguinal, hernia, pain, inguinodynia, mesh
Brief summary
The investigators describe a new surgical technique for inguinal hernia open repair, which will be compared with the Lichtenstein technique. The investigators seek to find the difference between the two techniques in postoperative pain.
Detailed description
The investigators randomly assigned 168 adult patients with uncomplicated primary inguinal hernia to two treatment groups: Group A: 84 patients treated with the new technique Group B: 84 patients treated with the technique of Lichtenstein (gold standard) The investigators reviewed the patients operated on one week, one month, three months and six months after surgery. The investigators evaluated the presence of moderate to severe pain in each technique, as well as the intensity of pain, measured by visual analogue scale. The investigators also determined the presence of inguinal dysesthesias in each technique, measured by dermatome mapping.
Interventions
PROCEDUREElliptical domed mesh technique
A segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches
Sponsors
Instituto Mexicano del Seguro Social
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
* adult patients diagnosed with uncomplicated primary inguinal hernia * mentally healthy patients * patients without preoperative groin pain * patients eligible for outpatient surgery
Exclusion criteria
* patients with different surgical diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain one month after surgery | one month | Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test. |
| pain three months after surgery | three months | Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test. |
| pain six months after surgery | six months | Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| dysesthesia one month after surgery | one month | Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible. |
| dysesthesia three months after surgery | three months | Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible. |
| dysesthesia six months after surgery | six months | Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible. |
Countries
Mexico
Contacts
Primary ContactRafal L Smolinski, surgeon
Backup ContactSergio E Solorio, researcher
Outcome results
None listed