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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07511764
Enrollment
266
Registered
2026-04-06
Start date
2025-12-01
Completion date
2026-06-01
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia Repair

Keywords

inguinal hernia, laparoscopy, laryngeal mask airway

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.

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.

Interventions

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

Sponsors

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Lead SponsorOTHER
Çam Sakura Şehir Hastanesi
CollaboratorUNKNOWN
Mardin Training and Research Hospital
CollaboratorUNKNOWN
Dicle University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Oxygen Saturationperioperative periodPatients' oxygen saturation levels will be monitored using peripheral spO2.
end-tidal carbondioxide levelsperioperative periodPatients' end-tidal CO2 levels will be monitored using capnography.
airway safetyperioperative periodThe development and management of complications related to airway safety (such as laryngospasm, bronchospasm, desaturation, and aspiration) in patients will be monitored.

Secondary

MeasureTime frame
peak airway pressureperioperative period
PACU durationpostoperative period

Countries

Turkey (Türkiye)

Contacts

CONTACTFikret Salık, associate professor
fikretsalik@gmail.com+905076214125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026