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Completed

NCT Number: NCT05702710

Minimal Invasive Treatment of Inguinal Hernia in Neonates

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.

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Maltepe University Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Surgery (PIRS)

Other

Laparoscopic procedure for repair of inguinal hernia as described in:

  • 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.

Other names: Percutaneous Internal Ring Suturing

Primary outcomes

  1. Surgery Time

    Time frame: Measured as time from skin prep until dressing is performed (approx. 20-30minutes)

    Time from skin prep to end of dressing

  2. Anesthesia Time

    Time frame: Measured in minutes from induction to awakening (approx. 30-40minutes)

    Time from induction to awakening

  3. Presence of Contralateral Patent Processus Vaginalis

    Time frame: Measured during surgery (approx. 5-10minutes)

    Whether a patent processus vaginalis was observed and repaired on laparoscopy

Secondary outcomes

  1. Dose of Muscle Relaxant

    Time frame: Measured throughout surgery (20-30minutes)

    None, Subparalytic or Paralytic

  2. Type of Airway Management Used

    Time frame: Measured throughout surgery (20-30minutes)

    ETT (Endotracheal Tube) or LMA (Laryngeal Mask Airway)

Sponsors and collaborators

Lead sponsor

Maltepe University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2023
Registry last updated
Apr 3, 2023

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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