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Recruiting NCT07511764

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

No phase Interventional Inguinal Hernia Repair

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: General Aneasthesia.
Who it may be relevant to
Registry conditions: Inguinal Hernia Repair. Basic parameters: 1 year — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Oxygen Saturation [Time frame: perioperative period]
  • end-tidal carbondioxide levels [Time frame: perioperative period]
  • airway safety [Time frame: perioperative period]
Secondary outcome measures (2)
  • peak airway pressure [Time frame: perioperative period]
  • PACU duration [Time frame: postoperative period]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Dicle University — Diyarbakır

Identifiers

NCT: NCT07511764 · 390/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗