Inguinal HerniaNCT04280094
Can Ideal Mesh Size be Standardized in Open Inguinal Hernia Repair
An observational study of Inguinal Hernia, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2020to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male patients over the age of 18 who apply to the hospital for inguinal hernia surgery constitute the study population.
Who may be able to join
- Male patients over 18 years of age who applied for inguinal hernia surgery
Who cannot join
- Patients under the age of 18
- Complicated hernias
- Recurrent hernias
- Those undergoing laparoscopic hernia repair
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42090
About this study
Official title: 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.
Read the 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.
- Conditions
- Inguinal Hernia
- Medical subject headings
- Hernia, Inguinal
What is being measured
The primary outcome is the main question the study is designed to answer.
Can Ideal Mesh Size be Standardized in Open Inguinal Hernia Repair
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.
Measured: The time period of the study was determined as 1 March 2020 and 15 May 2020.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start2 Jun 2020
- Primary completion30 Oct 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alpaslan Şahin, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280094
- Sponsor's protocol ID
- SBU Konya SUAM
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I don't want to share if it is not necessary
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.
PubMed 31222460Anitha 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.
PubMed 29974028
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Ideal Mesh Size be Standardized for Open Inguinal Hernia Repair; An Anthropometric Study in Central Anatolian Male Patients
- ClinicalTrials.gov ID
- NCT04280094
- Acronym / sponsor ID
- SBU Konya SUAM
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients over the age of 18 who apply to the hospital for inguinal hernia surgery constitute the study population.
Key inclusion criteria (1 listed)
- Male patients over 18 years of age who applied for inguinal hernia surgery
Key exclusion criteria (4 listed)
- Patients under the age of 18
- Complicated hernias
- Recurrent hernias
- Those undergoing laparoscopic hernia repair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 31222460Kulacoglu 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.
- Background: PubMed 29974028Anitha 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.
- Individual participant dataSharing planned: No. I don't want to share if it is not necessary
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04280094, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.