Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

NCT ID: NCT03488342

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-11-30

Brief Summary

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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

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

Conditions

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Primary Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

randomized,controlled and double-blind study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double (Participant, Investigator)

Study Groups

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Rives technique

Rives technique for primary inguinal hernia

Group Type OTHER

Repair for primary inguinal hernia

Intervention Type PROCEDURE

Repair for primary inguinal hernia

Lichtenstein repair

Lichtenstein repair for primary inguinal hernia

Group Type OTHER

Repair for primary inguinal hernia

Intervention Type PROCEDURE

Repair for primary inguinal hernia

Interventions

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Repair for primary inguinal hernia

Repair for primary inguinal hernia

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

93 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Siberia-Serena

OTHER

Sponsor Role lead

Responsible Party

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José Jacob Motos Micó

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Siberia Serena

Talarrubias, Badajoz, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Enrique Javier Grau Talens, PhD

Role: CONTACT

+34616182400

José Jacob Motos Micó, MD

Role: CONTACT

+34633257986

Facility Contacts

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Enrique Javier Grau Talens, PhD

Role: primary

+34616182400

José Jacob Motos Micó, MD

Role: backup

+34633257986

Other Identifiers

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HSiberia-Serena

Identifier Type: -

Identifier Source: org_study_id

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