NCT01211067

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
Last Updated

September 29, 2010

Status Verified

September 1, 2010

Enrollment Period

5 months

First QC Date

September 28, 2010

Last Update Submit

September 28, 2010

Conditions

Keywords

Inguinal herniaInguinal ringHistologyHernioplastyLichtenstein

Outcome Measures

Primary Outcomes (1)

  • Histology of the internal inguinal ring

    Histology and histological findings of the internal inguinal ring in patients submitted to elective surgical reparation of an indirect inguinal hernia

    6 months

Study Arms (3)

Patients age: 15 - 40 years-old

Patients within the 15 to 40 years-old age-group

Procedure: Lichtenstein hernioplasty

Patients age: 41 to 60 years-old

Patients within the group-age from 41 to 60 years-old

Procedure: Lichtenstein hernioplasty

Patients age: older than 61 years-old

Patients within the group-age from 61 years-old and older

Procedure: Lichtenstein hernioplasty

Interventions

* Mesh hernioplasty * Ultrapro mesh (Ethicon, Johnson \& Johnson)

Patients age: 15 - 40 years-oldPatients age: 41 to 60 years-oldPatients age: older than 61 years-old

Eligibility Criteria

Age15 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de La Serena

La Serena, Coquimbo Region, IV REGION, Chile

Location

Hospital de La Serena

La Serena, Coquimbo Region, Chile

Location

Related Publications (1)

  • Barria C, Beltran MA, Contreras MA, Cruces KS. Histology of the internal inguinal ring: it is really a novelty? Hernia. 2010 Jun;14(3):339-40. doi: 10.1007/s10029-010-0661-4. Epub 2010 May 1. No abstract available.

    PMID: 20437189BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

A 1 cm tissue sample of the internal inguinal ring taken during elective hernioplasty

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Marcelo A Beltrán, M.D.

    Hospital de La Serena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2010

First Posted

September 29, 2010

Study Start

September 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

September 29, 2010

Record last verified: 2010-09

Locations