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

NCT07511764 | Recruiting

• 1 other identifier: 390/2025
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Inguinal Hernia Repair

Keywords

inguinal hernia; laparoscopy; laryngeal mask airway

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• peak airway pressure

  perioperative period

• PACU duration

  postoperative period

Study Arms (2)

Patients received general anesthesia, with Laryngeal Mask Airway (LMA)

ACTIVE COMPARATOR

Patient group in whom mechanical ventilation is provided via LMA during general anesthesia.

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.

Procedure: General Aneasthesia

Interventions

General Aneasthesia PROCEDURE

Laryngeal mask airway (LMA) or endotracheal intubation (ETT) in pediatric laparoscopic inguinal hernia repair

Patients received general anesthesia, endotracheal entubation; Patients received general anesthesia, with Laryngeal Mask Airway (LMA)

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead
• Başakşehir Çam & Sakura City Hospital: collaborator
• Mardin Training and Research Hospital: collaborator
• Dicle University: collaborator

Study Sites (1)

Dicle University

Diyarbakır, Eyalet/Yerleşke, 21070, Turkey (Türkiye)

RECRUITING

Related Links

• Latest publication about similar work-up

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fikret Salık, associate professor

CONTACT

+905076214125; fikretsalik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicine Doctor Associate Professor in Anesthesiology

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 months after publication of results
• Access Criteria: medicine doctors

Locations

TU (1)