Clinical trial NCT06856304: Percutaneous Internal Ring Suturing Versus Conventional Laparoscopic Repair of Congenital Inguinal Hernia
Official title: Percutaneous Internal Ring Suturing Versus Conventional Laparoscopic Repair of Congenital Inguinal Hernia: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatrics
Inguinal Hernia Repair
Keywords: Laparoscopy
inguinal hernia
PIRS
sac disconnection
Narrowing of the internal ring
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 109
Sex: MALE
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:comparison between percutaneous internal ring suturing vs Conventional Laparoscopic Repair of Congenital Inguinal Hernia in male patients. Methods : this is a prospective randomized study including 109 male patients with 120 CIHs Patients were randomly categorized into two groups. Group A were subjected to laparoscopic disconnection of the hernia sac and narrowing of the internal ring (IR). Group B underwent PIRS. The intended primary outcome was recurrence within 1 year, besides comparing the two techniques regarding operative time, efficacy, safety, cosmetic outcome, and postoperative complications.

Detailed description: Introduction Since the 1990s laparoscopy has gained popularity in the management of Congenital inguinal hernia (CIH). Several laparoscopic techniques have been described, including laparoscopic disconnection of the hernial sac with narrowing of the internal ring (IIR) which was described to mimic the open technique, and the extraperitoneal approach involves using various types of needles under laparoscopic guidance to percutaneously secure a suture circumferentially around the internal ring, thus obliterating the sac opening. This study compared the short-term outcome of percutaneous internal ring suturing (PIRS) versus laparoscopic disconnection of the hernial sac with narrowing of the internal ring in children.

Materials and Methods: This study included 109 male patients with 120 CIHs during the period from May 2022 to May 2024. Patients were randomly categorized into two groups. Group A were subjected to laparoscopic disconnection of the hernia sac and narrowing of the internal ring (IR). Group B underwent PIRS. The intended primary outcome was recurrence within 1 year, besides comparing the two techniques regarding operative time, efficacy, safety, cosmetic outcome, and postoperative complications.

Eligibility criteria: Inclusion Criteria:

* male patients
* age of 6 month to 5years
* reduciable congenital inguinal hernia either unilateral or bilateral.

Exclusion Criteria:

* incarcerated CIH
* recurrent CIH
* patients with undescended testis,
* patients with hydrocele,
* patients with chronic comorbidity such as congenital heart disease and severe chest troubles

Primary outcomes:
measure: operative time
timeFrame: the time estimated during the operation
measure: intraoperative safety
timeFrame: the time estimated during the operation
measure: Recurrence of the inguinal hernia
timeFrame: 1 year
Secondary outcomes:
measure: cosmesis
timeFrame: 1 year
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: University of Alexandria
name: Mohamed Abouheba, Assistant Professor
role: STUDY_DIRECTOR
References: