Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

NCT03488342 | Unknown DMC

• 1 other identifier: HSiberia-Serena
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Inguinal Hernia

Keywords

Rives technique; Lichtenstein repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluate the chronic pain

  1 year

• Evaluate the recurrences

  1 year

Study Arms (2)

Rives technique

OTHER

Rives technique for primary inguinal hernia

Procedure: Repair for primary inguinal hernia

Lichtenstein repair

OTHER

Lichtenstein repair for primary inguinal hernia

Procedure: Repair for primary inguinal hernia

Interventions

Repair for primary inguinal hernia PROCEDURE

Repair for primary inguinal hernia

Lichtenstein repair; Rives technique

Eligibility Criteria

• Age: 18 Years - 93 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refusal to give informed consent. Refusal to participate giant inguinal hernias

Sponsors & Collaborators

• Hospital Siberia-Serena: lead

Study Sites (1)

Hospital Siberia Serena

Talarrubias, Badajoz, 06640, Spain

RECRUITING

MeSH Terms

Interventions

Wound Healing

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Central Study Contacts

Enrique Javier Grau Talens, PhD

CONTACT

+34616182400; ejgtalens@yahoo.es

José Jacob Motos Micó, MD

CONTACT

+34633257986; jacob_motos@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized,controlled and double-blind study

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 5, 2018
• Study Start: September 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-03

Locations

ES (1)