Study of Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia

September 28, 2010 updated by: Cirujanos la Serena

Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia

The histology of the internal inguinal ring in patients with indirect hernia submitted to elective surgery was studied. In contrast with recently published studies, the investigators believe that histological findings of the internal inguinal ring would reflect those associated and expected with normal aging.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Coquimbo
      • La Serena, Coquimbo, Chile
        • Hospital de La Serena
    • Iv Region
      • La Serena, Iv Region, Chile, IV REGION
        • Hospital de La Serena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with indirect inguinal hernia submitted to elective surgery with the Lichtenstein hernioplasty technique

Description

Inclusion Criteria:

  • Male gender
  • Older than 15 years-of-age
  • Unilateral indirect inguinal hernia
  • Non-smokers
  • Non-diabetics
  • Non-connective tissue conditions
  • Primary inguinal hernia

Exclusion Criteria:

  • Female gender
  • Younger than 15 years-of-age
  • Bilateral inguinal hernia
  • Direct or combined direct-indirect inguinal hernia
  • Femoral hernia
  • Smokers
  • Diabetics
  • Other connective tissue diseases
  • Recurrent inguinal hernia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients age: 15 - 40 years-old
Patients within the 15 to 40 years-old age-group
  • Mesh hernioplasty
  • Ultrapro mesh (Ethicon, Johnson & Johnson)
Patients age: 41 to 60 years-old
Patients within the group-age from 41 to 60 years-old
  • Mesh hernioplasty
  • Ultrapro mesh (Ethicon, Johnson & Johnson)
Patients age: older than 61 years-old
Patients within the group-age from 61 years-old and older
  • Mesh hernioplasty
  • Ultrapro mesh (Ethicon, Johnson & Johnson)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histology of the internal inguinal ring
Time Frame: 6 months
Histology and histological findings of the internal inguinal ring in patients submitted to elective surgical reparation of an indirect inguinal hernia
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: MARCELO A BELTRAN, M.D., Hospital de La Serena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

September 29, 2010

Last Update Submitted That Met QC Criteria

September 28, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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