Inguinal Hernia Repair and Male Fertility

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

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2020-12-15

Brief Summary

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General objective: To evaluate the fertility of adult men submitted to bilateral herniorrhaphy with mesh placement by the Lichtenstein and laparoscopic approaches

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Detailed Description

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Specific objectives: To correlate pre and postoperative data (90 and 180 days) of adult men, according to biochemistry parameters (hemogram and CRP), autoimmune (anti-sperm antibodies), hormonal (FSH, LH and testosterone), perfusion and volume testicular (USG of testicles with Doppler), spermogram, sexual changes, pain and quality of life (standard questionnaires).

Conditions

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Inguinal Hernia Bilateral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial with two groups, in according to hernioplasty correction approach

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Masking couldn't be possible because of the surgical technique

Study Groups

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Lichtenstein

Conventional approach

Group Type ACTIVE_COMPARATOR

Bilateral hernioplasty

Intervention Type PROCEDURE

Laparoscopy

Experimental approach

Group Type EXPERIMENTAL

Bilateral hernioplasty

Intervention Type PROCEDURE

Interventions

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Bilateral hernioplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male
* Age between 19 and 60 years old
* Bilateral inguinal hernia
* Primary and reducible inguinal hernia

Exclusion Criteria

* Age less than 19 or more than 60 years old
* ASA \>III
* Genito-urinary infection
* Immunodeficiency
* History of testicular trauma2
* History of surgery or pelvic radiotherapy
* History of testicular disease
* Fertility problems or sexual
* Illness that can be infertile
* Recurrent hernia
* Unilateral hernia
* Femoral or inguine-scrotal hernia
* Imprisoned hernia
* Use of Gonadotrophins
* Use of anabolic steroids

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes