Study of Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia
Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia
1 other identifier
observational
72
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2009
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 28, 2010
CompletedFirst Posted
Study publicly available on registry
September 29, 2010
CompletedSeptember 29, 2010
September 1, 2010
5 months
September 28, 2010
September 28, 2010
Conditions
Keywords
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
Patients age: 41 to 60 years-old
Patients within the group-age from 41 to 60 years-old
Patients age: older than 61 years-old
Patients within the group-age from 61 years-old and older
Interventions
* Mesh hernioplasty * Ultrapro mesh (Ethicon, Johnson \& Johnson)
Eligibility Criteria
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
Hospital de La Serena
La Serena, Coquimbo Region, Chile
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
A 1 cm tissue sample of the internal inguinal ring taken during elective hernioplasty
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcelo A Beltrán, M.D.
Hospital de La Serena
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