Actively Recruiting

Phase Not Applicable
Age: 1Year - 10Years
All Genders
NCT07511764

Comparison of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair: A Multicenter, Prospective, Randomized Controlled Clinical Trial

Led by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Updated on 2026-04-06

266

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

S

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Lead Sponsor

B

Başakşehir Çam & Sakura City Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Comparison of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair: A Multicenter, Prospective, Randomized Controlled Clinical Trial

Who Can Participate

Age: 1Year - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child is between 1 and 10 years old
  • Scheduled for laparoscopic inguinal hernia repair
  • Classified as American Society of Anesthesiologists (ASA) class I or II
  • Informed consent obtained from parent or guardian
Not Eligible

You will not qualify if you...

  • Obesity with body weight above the 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 laparoscopic to open surgery
  • Additional systemic risks such as immunodeficiency or malignancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dicle University

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

Actively Recruiting

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Research Team

F

Fikret Salık, associate professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Comparison of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair: A Multicenter, Prospective, Randomized Controlled Clinical Trial | DecenTrialz