Minimal Invasive Treatment of Inguinal Hernia in Neonates

Study Overview
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Brief Summary
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In this study, preoperative physical examination findings, peroperative findings and data, and postoperative follow-up results of newborns who underwent inguinal hernia repair with PIRS (Percutaneous Internal Ring Suturing) method will be evaluated retrospectively.

Detailed Description
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Congenital inguinal hernia is one of the most common surgical pathologies of childhood. Its treatment includes high ligation of the patent processus vaginalis by open or laparoscopic method. There are many described minimally invasive/laparoscopic repair techniques of inguinal hernias in children. One of them is percutaneous internal ring suturing or Percutaneous Inner Ring Suturing. There are many studies on the PIRS method in children. Two of these studies are prospective clinical studies published previously by the investigators of this study: in the first, the PIRS method was shown to be a safe and effective method for minimally invasive repair of inguinal hernia in children, and in the second, the use of subparalytic laryngeal masks in anesthesia of patients who underwent PIRS was shown to be sufficient for airway protection and anesthesia management in children undergoing laparoscopy. Although there are many studies on the repair of inguinal hernia in children with PIRS or other minimally invasive methods in the last decade, there are very limited studies on the use of these methods in newborns, a special group of childhood patients. In the literature, there is no study examining only newborn patients. In this context, the study will be a first in the literature.

Official Title
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Percutaneous Internal Ring Suturing is a Safe and Effective Method in the Minimal Invasive Treatment of Inguinal Hernia in Neonates

Conditions
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Inguinal Hernia, Surgery

Intervention / Treatment
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* Other: Surgery (PIRS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having undergone PIRS surgery at the study institute between October 1, 2015 and January 1, 2023 Age between 0-28 days Exclusion Criteria: Age > 28 days Having had surgery with open surgery Having another surgical procedure performed in the same session

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates Undergoing PIRS<br>All children <28 days of age undergoing PIRS for inguinal hernia repair | Other: Surgery (PIRS)<br>* Laparoscopic procedure for repair of inguinal hernia as described in: 1) Thomas DT, Göcmen KB, Tulgar S, Boga I. Percutaneous internal ring suturing is a safe and effective method for the minimal invasive treatment of pediatric inguinal hernia: Experience with 250 cases. J Pediatr Surg. 2016 Aug;51(8):1330-5. doi: 10.1016/j.jpedsurg.2015.11.024. Epub 2015 Dec 11. PMID: 26777889.<br>* Other names: Percutaneous Internal Ring Suturing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery Time | Time from skin prep to end of dressing | Measured as time from skin prep until dressing is performed (approx. 20-30minutes) | 
| Anesthesia Time | Time from induction to awakening | Measured in minutes from induction to awakening (approx. 30-40minutes) | 
| Presence of Contralateral Patent Processus Vaginalis | Whether a patent processus vaginalis was observed and repaired on laparoscopy | Measured during surgery (approx. 5-10minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of Muscle Relaxant | None, Subparalytic or Paralytic | Measured throughout surgery (20-30minutes) | 
| Type of Airway Management Used | ETT (Endotracheal Tube) or LMA (Laryngeal Mask Airway) | Measured throughout surgery (20-30minutes) |