Clinical Trials Directory

Trials / Completed

CompletedNCT05702710

Minimal Invasive Treatment of Inguinal Hernia in Neonates

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

Status
Completed
Phase
Study type
Observational
Enrollment
34 (actual)
Sponsor
Maltepe University · Academic / Other
Sex
All
Age
1 Day – 28 Days
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSurgery (PIRS)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.

Timeline

Start date
2023-01-30
Primary completion
2023-03-01
Completion
2023-03-15
First posted
2023-01-27
Last updated
2023-04-03

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05702710. Inclusion in this directory is not an endorsement.