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: Inguinal Hernia Repair
• Intervention / Treatment: Procedure: General Aneasthesia

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.

266 patients will be included in the study. Patients will be randomly assigned to two groups using a simple randomization method: 1) those who received general anesthesia with LMA (n=133), 2) those who received general anesthesia with endotracheal intubation.

The study population will consist of pediatric patients aged 1-10 years who are scheduled for elective laparoscopic inguinal hernia repair and are classified as American Society of Anesthesiologists (ASA) I-II. Inclusion criteria are: being aged 1-10 years, having a scheduled laparoscopic inguinal hernia repair, being classified as ASA I-II, and having given informed parental consent.

Exclusion criteria include: obesity (body weight >95th percentile), symptomatic gastroesophageal reflux, conditions with a 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, and the presence of additional systemic risks such as immunodeficiency/malignancy.

Anesthesia protocols will be standardized across all centers. Demographic and clinical characteristics of patients, such as age, ASA, presence of comorbidities, medications used, and history of previous surgery, will be recorded. Primary outcome measures are: oxygen saturation (SpO₂), end-tidal carbon dioxide (EtCO₂) level, and airway safety (complications such as laryngospasm, bronchospasm, desaturation, and aspiration). Secondary outcome measures include parameters such as peak airway pressure (PAP), mean airway pressure, anesthesia duration, muscle relaxant requirement, recovery time, PACU dwell time, postoperative airway signs (cough, stridor), and the need for conversion from LMA to ETT.

• Study Type: Interventional
• Enrollment (Estimated): 266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fikret Salık, associate professor; Phone Number: +905076214125; Email: fikretsalik@gmail.com

Study Locations

• Turkey (Türkiye)
  • Eyalet/Yerleşke
    • Diyarbakır, Eyalet/Yerleşke, Turkey (Türkiye), 21070
      • Recruiting
      • Dicle University
      • Contact: Fikret Salık; Phone Number: +905076214125; Email: fikretsalik@gmail.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Patients' oxygen saturation levels will be monitored using peripheral spO2.	perioperative period
end-tidal carbondioxide levels	Patients' end-tidal CO2 levels will be monitored using capnography.	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.	perioperative period

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• Collaborators: Dicle University; Mardin Training and Research Hospital; Çam Sakura Şehir Hastanesi

Publications and helpful links

Helpful Links

• Latest publication about similar work-up

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 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): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: laparoscopy; inguinal hernia; laryngeal mask airway
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Inguinal
• 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