Indirect Inguinal HerniaNCT01211067
Study of Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia
An observational study of Indirect Inguinal Hernia, run by Cirujanos la Serena at 2 sites in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older, men only
- Conditions the study is for
- Indirect Inguinal Hernia
- What is being tested?
- Lichtenstein hernioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 2 sitesChile
- Study dates
- Sep 2009to Feb 2010
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with indirect inguinal hernia submitted to elective surgery with the Lichtenstein hernioplasty technique
Who may be able to join
- Male gender
- Older than 15 years-of-age
- Unilateral indirect inguinal hernia
- Non-smokers
- Non-diabetics
- Non-connective tissue conditions
- Primary inguinal hernia
Who cannot join
- Female gender
- Younger than 15 years-of-age
- Bilateral inguinal hernia
- Direct or combined direct-indirect inguinal hernia
- Femoral hernia
- Smokers
Show all 9Show fewer
- Diabetics
- Other connective tissue diseases
- Recurrent inguinal hernia
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital de La Serena
La Serena, Coquimbo Region, IV REGION
Hospital de La Serena
La Serena, Coquimbo Region
About this study
Official title: 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.
- Conditions
- Indirect Inguinal Hernia
- Being tested
- Lichtenstein hernioplasty
- Keywords
- Inguinal hernia, Inguinal ring, Histology, Hernioplasty, Lichtenstein
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein hernioplastyProcedure or surgery
- Mesh hernioplasty
- Ultrapro mesh (Ethicon, Johnson \& Johnson)
| Study group | Role | What they receive |
|---|---|---|
| Patients age: 15 - 40 years-old | Patients within the 15 to 40 years-old age-group Receives: Procedure: Lichtenstein hernioplasty | |
| Patients age: 41 to 60 years-old | Patients within the group-age from 41 to 60 years-old Receives: Procedure: Lichtenstein hernioplasty | |
| Patients age: older than 61 years-old | Patients within the group-age from 61 years-old and older Receives: Procedure: Lichtenstein hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Indirect Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cirujanos la Serena
- Sponsor type
- University, hospital or other
- Investigators
- Marcelo A Beltrán, M.D., Principal investigator, Hospital de La Serena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211067
- Sponsor's protocol ID
- HLS-0015-1109
- Status last verified
- Sep 2010
- First submitted
- 28 Sep 2010
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20437189