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Completed

NCT Number: NCT06856304

Percutaneous Internal Ring Suturing Versus Conventional Laparoscopic Repair of Congenital Inguinal Hernia

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.

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Key information

Conditions

Pediatrics Hernia Hernia, Abdominal Hernia, Inguinal Inguinal Hernia Repair Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

6 month–5 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Alexandria, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

laparoscopic disconnection of the hernia sac

Procedure

disconnection of the hernial sac at the level of the internal ring using hook diathermy with sweeping the vas and the vessels away till completely separating them from the edges of the sac, then narrowing of the internal ring by appling a vicryl 3/0 suture between the ilipubic tract and the transverse arch of the transversus abdominus muscle

Percutaneous Internal Ring Suturing

Procedure

A single umbilical trocar was placed through a supraumbilical incision, and then the surgeon stood on the same side of the hernia. To choose the location for the needle puncture, the position of the IIR was assessed by pressing the inguinal region from the outside with the tip of a forceps. Under laparoscopic-guided vision, the previously prepared 18-gauge injection needle threaded with the monofilament suture was introduced into the abdominal wall through a skin puncture at the lateral edge of the internal ring. With the movements of the tip of the needle, the thread passed under the peritoneum, over the lateral half of the IIR. The thread was pushed through the barrel of the needle into the abdominal cavity and eventually made a loop. The needle was pulled out, leaving the loop of the thread inside the abdomen by hanging the loop on the endoscope this prevented the extraction of the loop with the needle and thus prevented repeating this step. Next, the thread loop was pulled out of t

Primary outcomes

  1. operative time

    Time frame: the time estimated during the operation

    time of the procedure estimated after trocars insertion and Inflation of the abdomen till deflation of the abdomen

  2. intraoperative safety

    Time frame: the time estimated during the operation

    injury of the vas deffernce , spermatic vessels , bleeding

  3. Recurrence of the inguinal hernia

    Time frame: 1 year

    postoperative swelling in the inguinal region with gurgling sensation

Secondary outcomes

  1. cosmesis

    Time frame: 1 year

    postoperative scar

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Percutaneous Internal Ring Suturing Versus Conventional Laparoscopic Repair of Congenital Inguinal Hernia: a Prospective Randomized Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

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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