- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04280094
Can Ideal Mesh Size be Standardized in Open Inguinal Hernia Repair
February 26, 2024 updated by: Alpaslan Şahin, Konya Meram State Hospital
Can the Ideal Mesh Size be Standardized for Open Inguinal Hernia Repair; An Anthropometric Study in Central Anatolian Male Patients
Two hundred consecutive unilateral inguinal hernia patients will be included in the study.
Patients will be recorded by measuring the distance between the pubic tubercle and the deep inguinal ring, the distance between the inguinal ligament and the internal oblique aponeurosis, the distance between the deep and superficial inguinal ring diameters and their anterior superior iliac spine.
The contribution of these measures to the determination of the ideal mesh size will be analyzed.
Study Overview
Status
Completed
Conditions
Detailed Description
This prospective study includes 200 consecutive male patients who underwent unilateral open inguinal hernia repair since March 2020.
Under-18 hernias, complicated hernias, recurrent hernias, and those with laparoscopic hernia repair will be excluded.
Initially, the distance between the pubic tubercle and the medial edge of the deep inguinal ring will be measured.
Next, the distance between the inner edge of the inguinal ligament and the upper level of the internal oblique aponeurosis will be measured at the Hesselbach triangle.
Hesselbach triangle area will be calculated.
The diameter of the superficial and deep inguinal ring and their spina iliaca anterior superior (SIAS) distance will be measured.
The contribution of these measures to the determination of the ideal mesh size will be analyzed.
Study Type
Observational
Enrollment (Actual)
1
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
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Konya, Turkey, 42090
- Konya Training and Research Hospital
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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
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Male patients over the age of 18 who apply to the hospital for inguinal hernia surgery constitute the study population.
Description
Inclusion Criteria:
- Male patients over 18 years of age who applied for inguinal hernia surgery
Exclusion Criteria:
- Patients under the age of 18
- Complicated hernias
- Recurrent hernias
- Those undergoing laparoscopic hernia repair
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: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Can Ideal Mesh Size be Standardized in Open Inguinal Hernia Repair
Time Frame: The time period of the study was determined as 1 March 2020 and 15 May 2020.
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Patients will be recorded by measuring the distance between the pubic tubercle and the deep inguinal ring, the distance between the inguinal ligament and the internal oblique aponeurosis, the distances between the deep and superficial inguinal ring diameters and the anterior superior iliac spine.
Then the data will be analyzed in the SPSS statistics program.
Average, maximum, and minimum values of anatomical dimensions will be subtracted.
Relationships with age, body length, and body mass index will be analyzed statistically, and the ideal mesh size detectability will be investigated.
When the analysis is completed, the study will be terminated.
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The time period of the study was determined as 1 March 2020 and 15 May 2020.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- Kulacoglu H, Celasin H, Oztuna D. Individual mesh size for open anterior inguinal hernia repair: an anthropometric study in Turkish male patients. Hernia. 2019 Dec;23(6):1229-1235. doi: 10.1007/s10029-019-01993-x. Epub 2019 Jun 20.
- Anitha B, Aravindhan K, Sureshkumar S, Ali MS, Vijayakumar C, Palanivel C. The Ideal Size of Mesh for Open Inguinal Hernia Repair: A Morphometric Study in Patients with Inguinal Hernia. Cureus. 2018 May 3;10(5):e2573. doi: 10.7759/cureus.2573.
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 (Actual)
June 2, 2020
Primary Completion (Actual)
October 30, 2020
Study Completion (Actual)
November 30, 2020
Study Registration Dates
First Submitted
February 19, 2020
First Submitted That Met QC Criteria
February 20, 2020
First Posted (Actual)
February 21, 2020
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBU Konya SUAM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
I don't want to share if it is not necessary
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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