Primary Inguinal Hernia
Conditions
Keywords
Rives technique, Lichtenstein repair
Brief summary
Lichtenstein technique, inserting a mesh over the inguinal cord in the neurological plane, is considered the standard of inguinal hernia repair, but it has 4% recurrence and 12% chronic postoperative pain. Rives technique inserts the mesh in the preperitoneal space behind the neurological plane and the muscular plane, thus better fulfilling the principle of hydrostatics.
Detailed description
These techniques have not been compared randomly for assessment of chronic pain, postoperative complications and recurrences
Interventions
PROCEDURERepair for primary inguinal hernia
Repair for primary inguinal hernia
Sponsors
Hospital Siberia-Serena
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Intervention model description
randomized,controlled and double-blind study
Eligibility
Sex/Gender
ALL
Age
18 Years to 93 Years
Healthy volunteers
No
Inclusion criteria
Men or women aged between 18 and 93 years (inclusive) at the time of the first screening visit. They must provide signed written informed consent and agree to comply the study protocol
Exclusion criteria
Refusal to give informed consent. Refusal to participate giant inguinal hernias
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate postoperative complications of pain | 7 days | The patients are clinically reviewed in the office within 7 days of discharge (pain is evaluated at rest and with movement (standing up, sitting down, and walking), using a VAS (visual analogue scale). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the chronic pain | 1 year | The patients are reviewed clinically by the service's surgeons again after a year. If pain is found, this is evaluated as being with movement, spontaneous, episodic, or constant in nature, and measured with a VAS. The patients are clinically reviewed in the office: pain is evaluated at rest and with movement (standing up, sitting down, and walking), using a VAS (visual analogue scale). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) |
| Evaluate the recurrences | 1 year | The patients are reviewed clinically by the service's surgeons again after a year. The inguinal region is examined. A mass, reducible or otherwise, is regarded as a recurrence. |
Countries
Spain
Contacts
Primary ContactEnrique Javier Grau Talens, PhD
Backup ContactJosé Jacob Motos Micó, MD
Outcome results
None listed