Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique in Inguinal Hernia

NCT ID: NCT01348477

Last Updated: 2011-05-05

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

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-12-31

Brief Summary

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The investigators describe a new surgical technique for inguinal hernia open repair, which will be compared with the Lichtenstein technique. The investigators seek to find the difference between the two techniques in postoperative pain.

Detailed Description

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The investigators randomly assigned 168 adult patients with uncomplicated primary inguinal hernia to two treatment groups:

Group A: 84 patients treated with the new technique Group B: 84 patients treated with the technique of Lichtenstein (gold standard) The investigators reviewed the patients operated on one week, one month, three months and six months after surgery. The investigators evaluated the presence of moderate to severe pain in each technique, as well as the intensity of pain, measured by visual analogue scale.

The investigators also determined the presence of inguinal dysesthesias in each technique, measured by dermatome mapping.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Elliptical domed mesh technique

84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique

Group Type EXPERIMENTAL

Elliptical domed mesh technique

Intervention Type PROCEDURE

A segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches

Lichtenstein technique

84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard)

Group Type ACTIVE_COMPARATOR

Elliptical domed mesh technique

Intervention Type PROCEDURE

A segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches

Interventions

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Elliptical domed mesh technique

A segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches

Intervention Type PROCEDURE

Other Intervention Names

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preperitoneal mesh

Eligibility Criteria

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Inclusion Criteria

* adult patients diagnosed with uncomplicated primary inguinal hernia
* mentally healthy patients
* patients without preoperative groin pain
* patients eligible for outpatient surgery

Exclusion Criteria

* patients with different surgical diagnosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mexican Social Security Institute

Principal Investigators

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Rafal L Smolinski, surgeon

Role: PRINCIPAL_INVESTIGATOR

IMSS

Martha A Hernandez, researcher

Role: STUDY_DIRECTOR

IMSS

Sergio E Solorio, researcher

Role: STUDY_CHAIR

IMSS

Locations

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Ambulatory care medical unit number 55 (UMAA 55)

León, Guanajuato, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Rafal L Smolinski, surgeon

Role: CONTACT

52-477-7768584

Sergio E Solorio, researcher

Role: CONTACT

52-477-7174800

Facility Contacts

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Rafal L Smolinski, surgeon

Role: primary

52-477-7768584

Sergio E Solorio, researcher

Role: backup

52-477-7174800

Other Identifiers

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R-2010-1005-10

Identifier Type: -

Identifier Source: org_study_id

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