İnguinal HerniaNCT06988293
Quality of Life Effects of Laparoscopic and Open Surgery in Inguinal Hernia Treatment
An observational study of İnguinal Hernia, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Inguinal hernia is the most common type of hernia, presenting with swelling and pain in the groin area as clinical signs of abdominal wall hernias. The gold standard treatment for symptomatic inguinal hernias is surgery. There are various surgical methods for inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- İnguinal Hernia
- What is being tested?
- inguinal hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Nov 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who had liechtenstein or TEP surgery due to inguinal hernia
Who may be able to join
- open and laparoscopic hernia repair surgery being over 18 years old approve the work
Who cannot join
- Being under 18 years old Emergency operated patients Patients using surgical techniques other than the open Liechtenstein method and laparoscopic extraperitoneal methods Patients who do not consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University
Kahramanmaraş, 46040
About this study
Official title: The Evaluation of the Long-Term Quality of Life Effects of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Surgery in Inguinal Hernia Treatment
Inguinal hernia is the most common type of hernia, presenting with swelling and pain in the groin area as clinical signs of abdominal wall hernias. The gold standard treatment for symptomatic inguinal hernias is surgery. There are various surgical methods for inguinal hernia repair. Tissue repair techniques such as Bassini, Shouldice, and McVay are no longer preferred due to their high recurrence rates, except in cases where mesh prosthetics are contraindicated. Tension-free mesh prosthesis-based anterior repairs and laparoscopic posterior repairs are the most frequently preferred methods in treatment. (1) In our study, we aimed to evaluate the quality of life index following laparoscopic extraperitoneal hernia repair using the most commonly preferred Lichtenstein technique. (2,3) The Short Form-36 (SF-36) scale is planned to be used for evaluating the quality of life index. SF-36 is one of the most commonly used generic measures for assessing quality of life. This scale examines eight dimensions of health, including physical function, social function, mental health, vitality (energy), pain, and general health perception, through 36 items. (4) Our study aims to determine which surgical method, based on long-term patient follow-up, stands out in improving the quality of life.
- Conditions
- İnguinal Hernia
- Being tested
- inguinal hernia repair
- Keywords
- inguinal hernia, short form-36, total extraperitoneal(TEP) hernia repair, Liechtenstein hernia repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inguinal hernia repairProcedure or surgery
İnguinal hernia repair quality of life index
| Study group | Role | What they receive |
|---|---|---|
| Liechtenstein and TEP hernia repair group | Not described Receives: Procedure: inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 index
Measured: at least 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Jan 2020
- Primary completion1 Dec 2023
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for İnguinal 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
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Isler, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988293
- Sponsor's protocol ID
- KahramanmaraşSIU-İŞLER-001
- Status last verified
- Jan 2025
- First submitted
- 16 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Long-Term Quality of Life Effects of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Surgery in Inguinal Hernia Treatment
- ClinicalTrials.gov ID
- NCT06988293
- Acronym / sponsor ID
- KahramanmaraşSIU-İŞLER-001
- Conditions
- İnguinal Hernia
- Keywords
- inguinal hernia, short form-36, total extraperitoneal(TEP) hernia repair, Liechtenstein hernia repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 23 May 2025 (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.
Inguinal hernia is the most common type of hernia, presenting with swelling and pain in the groin area as clinical signs of abdominal wall hernias. The gold standard treatment for symptomatic inguinal hernias is surgery. There are various surgical methods for inguinal hernia repair. Tissue repair techniques such as Bassini, Shouldice, and McVay are no longer preferred due to their high recurrence rates, except in cases where mesh prosthetics are contraindicated. Tension-free mesh prosthesis-based anterior repairs and laparoscopic posterior repairs are the most frequently preferred methods in treatment. (1) In our study, we aimed to evaluate the quality of life index following laparoscopic extraperitoneal hernia repair using the most commonly preferred Lichtenstein technique. (2,3) The Short Form-36 (SF-36) scale is planned to be used for evaluating the quality of life index. SF-36 is one of the most commonly used generic measures for assessing quality of life. This scale examines eight dimensions of health, including physical function, social function, mental health, vitality (energy), pain, and general health perception, through 36 items. (4) Our study aims to determine which surgical method, based on long-term patient follow-up, stands out in improving the quality of life.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liechtenstein and TEP hernia repair group | – | Procedure: inguinal hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had liechtenstein or TEP surgery due to inguinal hernia
Key inclusion criteria (1 listed)
- open and laparoscopic hernia repair surgery being over 18 years old approve the work
Key exclusion criteria (1 listed)
- Being under 18 years old Emergency operated patients Patients using surgical techniques other than the open Liechtenstein method and laparoscopic extraperitoneal methods Patients who do not consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inguinal hernia repairİnguinal hernia repair quality of life index | Procedure or surgery | Liechtenstein and TEP hernia repair group |
Primary outcome
SF-36 index
Time frame: at least 1 year after surgery
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 23 May 2025.
- Individual participant dataSharing planned: No
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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 İnguinal Hernia, run by Kahramanmaras Sutcu Imam University 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 1 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 23 May 2025. 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?
SF-36 index (time frame: at least 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2025.