Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

Randomized Clinical Trial of Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

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.

Study Overview

• Status: Unknown
• Conditions: Primary Inguinal Hernia
• Intervention / Treatment: Procedure: Repair for primary inguinal hernia

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Badajoz
    • Talarrubias, Badajoz, Spain, 06640
      • Recruiting
      • Hospital Siberia Serena
      • Contact: Enrique Javier Grau Talens, PhD; Phone Number: +34616182400; Email: ejgtalens@yahoo.es
      • Contact: José Jacob Motos Micó, MD; Phone Number: +34633257986; Email: jacob_motos@hotmail.com
      • Principal Investigator: Enrique Javier Grau Talens, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 93 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Rives technique; Rives technique for primary inguinal hernia	Procedure: Repair for primary inguinal hernia; Repair for primary inguinal hernia
OTHER: Lichtenstein repair; Lichtenstein repair for primary inguinal hernia	Procedure: Repair for primary inguinal hernia; Repair for primary inguinal hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate postoperative complications of pain	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)	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the chronic pain	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)	1 year
Evaluate the recurrences	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.	1 year

Collaborators and Investigators

• Sponsor: Hospital Siberia-Serena

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ANTICIPATED): November 1, 2018
• Study Completion (ANTICIPATED): November 1, 2018

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (ACTUAL): April 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Rives technique; Lichtenstein repair
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: HSiberia-Serena

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No