Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia
- Conditions
- Primary Inguinal Hernia
- Interventions
- Procedure: Repair for primary inguinal hernia
- Registration Number
- NCT03488342
- Lead Sponsor
- Hospital Siberia-Serena
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
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
Refusal to give informed consent. Refusal to participate giant inguinal hernias
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rives technique Repair for primary inguinal hernia Rives technique for primary inguinal hernia Lichtenstein repair Repair for primary inguinal hernia Lichtenstein repair for primary inguinal hernia
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Hospital Siberia Serena
🇪🇸Talarrubias, Badajoz, Spain