Inguinal Hernia RepairNCT07511764
Comparison of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair
A study testing General Aneasthesia in people with Inguinal Hernia Repair, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Inguinal hernia is one of the most common conditions requiring surgical intervention in childhood, with a reported lifetime prevalence of 1-4%. With the increasing use of minimally invasive techniques such as PIRS (Percutaneous Internal Ring Suturing) among laparoscopic surgical procedures, perioperative anesthesia… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Inguinal Hernia Repair
- What is being tested?
- General Aneasthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- being between 1 and 10 years of age,
- having a planned laparoscopic inguinal hernia repair,
- being classified as ASA I-II,
- having given informed consent from the parent.
Who cannot join
- Obesity (body weight >95th percentile),
- symptomatic gastroesophageal reflux,
- high risk of aspiration,
- upper airway anomalies,
- history of difficult intubation,
- acute respiratory tract infection,
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- emergency surgical indication,
- need for conversion from laparoscopy to open surgery,
- presence of additional systemic risks such as immunodeficiency/malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dicle University
Diyarbakır, Eyalet/Yerleşke, 21070
Fikret Salık, +905076214125, fikretsalik@gmail.com
About this study
Official title: Comparison of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair: A Multicenter, Prospective, Randomized Controlled Clinical Trial
Inguinal hernia is one of the most common conditions requiring surgical intervention in childhood, with a reported lifetime prevalence of 1-4%. With the increasing use of minimally invasive techniques such as PIRS (Percutaneous Internal Ring Suturing) among laparoscopic surgical procedures, perioperative anesthesia and airway management have become a critical area of clinical decision-making. The traditional approach in pediatric laparoscopic surgery is endotracheal intubation (ETT). Although ETT provides reliable airway control, it carries certain disadvantages. In contrast, the laryngeal mask airway (LMA) is less invasive and is associated with faster recovery. Systematic reviews and meta-analyses conducted in recent years have shown that the LMA may be safe for ventilation in pediatric laparoscopy, reduces peak airway pressure, and shortens recovery time. No well-designed, multicenter study with an adequate sample size comparing the LMA and ETT in pediatric laparoscopic inguinal hernia surgery has yet been conducted. This gap limits evidence-based decision-making in a clinical setting that directly impacts practice. Therefore, the aim of this study is to compare LMA and ETT in pediatric laparoscopic inguinal hernia repair. In this regard, the study is unique and necessary from both clinical and academic perspectives for determining the optimal airway strategy in pediatric laparoscopy.
Read the detailed description
This study is designed as a multicenter, prospective, randomized controlled clinical trial to compare laryngeal mask airway (LMA) and endotracheal intubation (ETT) in pediatric laparoscopic inguinal hernia repair.
- Conditions
- Inguinal Hernia Repair
- Being tested
- General Aneasthesia
- Keywords
- inguinal hernia, laparoscopy, laryngeal mask airway
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AneasthesiaProcedure or surgery
Laryngeal mask airway (LMA) or endotracheal intubation (ETT) in pediatric laparoscopic inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Patients received general anesthesia, with Laryngeal Mask Airway (LMA) | Active comparator | Patient group in whom mechanical ventilation is provided via LMA during general anesthesia. Receives: Procedure: General Aneasthesia |
| Patients received general anesthesia, endotracheal entubation | Active comparator | Patient group in whom mechanical ventilation is provided via endotracheal entubation during general anesthesia. Receives: Procedure: General Aneasthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation
Patients' oxygen saturation levels will be monitored using peripheral spO2.
Measured: perioperative period
end-tidal carbondioxide levels
Patients' end-tidal CO2 levels will be monitored using capnography.
Measured: perioperative period
airway safety
The development and management of complications related to airway safety (such as laryngospasm, bronchospasm, desaturation, and aspiration) in patients will be monitored.
Measured: perioperative period
Secondary outcomes (2)
peak airway pressure
Measured: perioperative period
PACU duration
Measured: postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Dec 2025
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia RepairStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Başakşehir Çam & Sakura City Hospital, Mardin Training and Research Hospital, Dicle University
- Responsible party
- Principal investigator, Fikret Salık, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511764
- Sponsor's protocol ID
- 390/2025
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IDP
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair: A Multicenter, Prospective, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07511764
- Acronym / sponsor ID
- 390/2025
- Conditions
- Inguinal Hernia Repair
- Keywords
- inguinal hernia, laparoscopy, laryngeal mask airway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Collaborators
- Başakşehir Çam & Sakura City Hospital, Mardin Training and Research Hospital, Dicle University
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 6 Apr 2026 (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 one of the most common conditions requiring surgical intervention in childhood, with a reported lifetime prevalence of 1-4%. With the increasing use of minimally invasive techniques such as PIRS (Percutaneous Internal Ring Suturing) among laparoscopic surgical procedures, perioperative anesthesia and airway management have become a critical area of clinical decision-making. The traditional approach in pediatric laparoscopic surgery is endotracheal intubation (ETT). Although ETT provides reliable airway control, it carries certain disadvantages. In contrast, the laryngeal mask airway (LMA) is less invasive and is associated with faster recovery. Systematic reviews and meta-analyses conducted in recent years have shown that the LMA may be safe for ventilation in pediatric laparoscopy, reduces peak airway pressure, and shortens recovery time. No well-designed, multicenter study with an adequate sample size comparing the LMA and ETT in pediatric laparoscopic inguinal hernia surgery has yet been conducted. This gap limits evidence-based decision-making in a clinical setting that directly impacts practice. Therefore, the aim of this study is to compare LMA and ETT in pediatric laparoscopic inguinal hernia repair. In this regard, the study is unique and necessary from both clinical and academic perspectives for determining the optimal airway strategy in pediatric laparoscopy.
Detailed description
This study is designed as a multicenter, prospective, randomized controlled clinical trial to compare laryngeal mask airway (LMA) and endotracheal intubation (ETT) in pediatric laparoscopic inguinal hernia repair.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients received general anesthesia, with Laryngeal Mask Airway (LMA) | Active comparator | Procedure: General AneasthesiaPatient group in whom mechanical ventilation is provided via LMA during general anesthesia. |
| Patients received general anesthesia, endotracheal entubation | Active comparator | Procedure: General AneasthesiaPatient group in whom mechanical ventilation is provided via endotracheal entubation during general anesthesia. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- being between 1 and 10 years of age,
- having a planned laparoscopic inguinal hernia repair,
- being classified as ASA I-II,
- having given informed consent from the parent.
Key exclusion criteria (9 listed)
- Obesity (body weight >95th percentile),
- symptomatic gastroesophageal reflux,
- high risk of aspiration,
- upper airway anomalies,
- history of difficult intubation,
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 |
|---|---|---|
| General AneasthesiaLaryngeal mask airway (LMA) or endotracheal intubation (ETT) in pediatric laparoscopic inguinal hernia repair | Procedure or surgery | Patients received general anesthesia, endotracheal entubation, Patients received general anesthesia, with Laryngeal Mask Airway (LMA) |
Primary outcome
Oxygen Saturation
Time frame: perioperative period
Patients' oxygen saturation levels will be monitored using peripheral spO2.
end-tidal carbondioxide levels
Time frame: perioperative period
Patients' end-tidal CO2 levels will be monitored using capnography.
airway safety
Time frame: perioperative period
The development and management of complications related to airway safety (such as laryngospasm, bronchospasm, desaturation, and aspiration) in patients will be monitored.
2 secondary outcomes
peak airway pressure
Time frame: perioperative period
PACU duration
Time frame: postoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Latest publication about similar work-upLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all collected IDP
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Aneasthesia in people with Inguinal Hernia Repair, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fikret Salık, associate professor (+905076214125, fikretsalik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Saturation (time frame: perioperative period). The study lists 3 primary outcomes in all. 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 24 Jun 2026.