Comparison of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair

June 19, 2026 updated by: Fikret Salık, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Eyalet/Yerleşke
      • Diyarbakır, Eyalet/Yerleşke, Turkey (Türkiye), 21070
        • Recruiting
        • Dicle University
        • Contact:

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Obesity (body weight >95th percentile),
  • symptomatic gastroesophageal reflux,
  • high risk of aspiration,
  • upper airway anomalies,
  • history of difficult intubation,
  • acute respiratory tract infection,
  • emergency surgical indication,
  • need for conversion from laparoscopy to open surgery,
  • presence of additional systemic risks such as immunodeficiency/malignancy.

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients received general anesthesia, with Laryngeal Mask Airway (LMA)
Patient group in whom mechanical ventilation is provided via LMA during general anesthesia.
Procedure: General Aneasthesia
Laryngeal mask airway (LMA) or endotracheal intubation (ETT) in pediatric laparoscopic inguinal hernia repair
Active Comparator: Patients received general anesthesia, endotracheal entubation
Patient group in whom mechanical ventilation is provided via endotracheal entubation during general anesthesia.
Procedure: General Aneasthesia
Laryngeal mask airway (LMA) or endotracheal intubation (ETT) in pediatric laparoscopic inguinal hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Saturation
Time Frame: perioperative period
Patients' oxygen saturation levels will be monitored using peripheral spO2.
perioperative period
end-tidal carbondioxide levels
Time Frame: perioperative period
Patients' end-tidal CO2 levels will be monitored using capnography.
perioperative period
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.
perioperative period

Secondary Outcome Measures

Outcome Measure
Time Frame
peak airway pressure
Time Frame: perioperative period
perioperative period
PACU duration
Time Frame: postoperative period
postoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Collaborators

Dicle University
Mardin Training and Research Hospital
Başakşehir Çam & Sakura City Hospital

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.

Helpful Links

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)

December 1, 2025

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 390/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IDP

IPD Sharing Time Frame

3 months after publication of results

IPD Sharing Access Criteria

medicine doctors

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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