Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

Overview

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.

Full Title of Study: “Randomized Clinical Trial of Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2018

Detailed Description

These techniques have not been compared randomly for assessment of chronic pain, postoperative complications and recurrences

Interventions

  • Procedure: Repair for primary inguinal hernia
    • Repair for primary inguinal hernia

Arms, Groups and Cohorts

  • Other: Rives technique
    • Rives technique for primary inguinal hernia
  • Other: Lichtenstein repair
    • Lichtenstein repair for primary inguinal hernia

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate postoperative complications of pain
    • Time Frame: 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 Measures

  • Evaluate the chronic pain
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 93 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Siberia-Serena
  • Provider of Information About this Clinical Study
    • Principal Investigator: José Jacob Motos Micó, Principal Investigator – Hospital Siberia-Serena
  • Overall Contact(s)
    • Enrique Javier Grau Talens, PhD, +34616182400, ejgtalens@yahoo.es

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