Comparing Two Types of Surgery for Children With Undescended Testicles When the Hernia Sac Is Tied or Not

NCT07319637 | Completed DMC

• 2 other identifiers: CPSP/REU/PSG-2023-290-572No.32/CH&ICH/FSD, 16-Jan-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

When a child has an undescended testicle that can be felt in the groin, surgery (orchiopexy) is needed to move it into the scrotum. During this operation, doctors sometimes tie off a small sac near the testicle, but this step can make the surgery longer and may slightly increase risks like swelling, infection, or irritation. This study looks at whether tying this sac is really necessary. It compares children who had surgery with sac ligation to those who had surgery without it. The goal is to see if there is any difference in surgery time or the chance of developing a hernia afterward. By understanding this, doctors can choose the safest and simplest approach for children with undescended testicles and provide better care.

Conditions

Undescended Testis

Keywords

Orchiopexy; sac ligation; Palpable Undescended testis

Outcome Measures

Primary Outcomes (2)

• Operative Time

  During surgery "from skin incision to skin closure", assessed at the time of the surgical procedure.

• Post-operative Complications

  Post-op hernia, Wound infection, Hematoma and Testicular atrophy

  at 0, 4, 8 and 12 weeks after surgery

Secondary Outcomes (2)

• Hospital stay duration, or Length of Stay (LOS) in the hospital

  From the day of the admission for procedure until hospital discharge, assessed during the index hospitalization (up to 7 days)

• Post-operative Pain Score

  Post-operative period, assessed at 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery.

Study Arms (2)

Group A

ACTIVE COMPARATOR

Orchiopexy with sac ligation

Procedure: Orchiopexy with sac ligation

Group B

EXPERIMENTAL

Orchiopexy without sac ligation

Procedure: Orchiopexy without sac ligation

Interventions

Orchiopexy without sac ligation PROCEDURE

To compare the outcome of the surgery with and without sac ligation in pediatric population with palpable undescended testes.

Group B

Orchiopexy with sac ligation PROCEDURE

To compare the outcome of the surgery with and without sac ligation in pediatric population with palpable undescended testes.

Group A

Eligibility Criteria

• Age: 6 Months - 15 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male children ≤15 years with palpable UDT
• Scheduled for single stage orchidopexy

You may not qualify if:

• Impalpable testes
• Staged/laparoscopic procedures,
• Pre-op hernia,
• History previous orchiopexy
• Ambiguous genitalia

Sponsors & Collaborators

• Children Hospital Faisalabad: lead

Study Sites (1)

Children Hospital & Institute of Child Health

Faisalābad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Cryptorchidism

Interventions

Orchiopexy

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 6, 2026
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 15, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)