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NCT Number: NCT07511764

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

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.

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Key information

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dicle University

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

Location status: Recruiting

Location contact

Fikret Salık

CONTACT

[email protected]

+905076214125

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

General Aneasthesia

Procedure

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

Primary outcomes

  1. Oxygen Saturation

    Time frame: perioperative period

    Patients' oxygen saturation levels will be monitored using peripheral spO2.

  2. end-tidal carbondioxide levels

    Time frame: perioperative period

    Patients' end-tidal CO2 levels will be monitored using capnography.

  3. 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.

Secondary outcomes

  1. peak airway pressure

    Time frame: perioperative period

  2. PACU duration

    Time frame: postoperative period

Study contacts

Contact information is provided by the study sponsor or research team.

Fikret Salık, associate professor

CONTACT

[email protected]

+905076214125

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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