Minimal Invasive Treatment of Inguinal Hernia in Neonates

Completed

• Conditions: Surgery; Inguinal Hernia
• Interventions: Other: Surgery (PIRS)

• Registration Number: NCT05702710
• Lead Sponsor: Maltepe University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Study Start: 2023-01-30
• Status Verified: 2023-03
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-15
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Having undergone PIRS surgery at the study institute between October 1, 2015 and January 1, 2023
2. Age between 0-28 days

Exclusion Criteria

1. Age > 28 days
2. Having had surgery with open surgery
3. Having another surgical procedure performed in the same session

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neonates Undergoing PIRS	Surgery (PIRS)	All children \<28 days of age undergoing PIRS for inguinal hernia repair

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maltepe University Hospital; 🇹🇷 Istanbul, Turkey