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CompletedNCT07319637Updated Jan 6, 2026

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

An interventional study of Orchiopexy without sac ligation and Orchiopexy with sac ligation in Undescended Testis, sponsored by Children Hospital Faisalabad. Completed at 1 site in Pakistan. Open to male participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Children Hospital Faisalabad · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Sep 2024, registered Dec 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
6 Months to 15 Years
Sex
Male
01

Study 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.

Read the detailed description

Cryptorchidism or Undescended testis (UDT) is described as testes that cannot be brought down to the bottom of scrotum without undue traction on the spermatic cord. It is one of the most common conditions presenting in pediatric surgical outpatient department1. UDT is seen in 2-4% of children at birth, decreasing to about 1% in the first year of life. It is prevalent in about one to four and a half percentage of newborns with a higher incidence in preterm babies (30-45%). UDT maybe unilateral or bilateral, mostly affecting the right side (70%).

The management of palpable undescended testes (UDT) in the pediatric population often necessitates surgical intervention to relocate the testes into the scrotum, a procedure known as orchiopexy. During this surgery, surgeons may choose to either ligate the hernia sac associated with the undescended testis or leave it unligated. The decision to ligate the sac is influenced by the belief that it might reduce the risk of post-operative complications such as inguinal hernias. However, this additional step could potentially prolong the operative time and introduce other risks.

Studies suggest there is probability of spontaneous decent in the first three months postnatally, beyond which it was rare. The recommended age for surgery for undescended testis is six months of age. The standard surgical intervention for orchiopexy was described in 1881-1899. The classical orchidopexy recommends the mandatory ligation of the hernial sac to prevent occurrence of postoperative hernia. This traditional conventional orchidopexy technique is well-acknowledged and generally practiced and is well supported by many studies that conclude that sac ligation is mandatory for the prevention of post-operative complication of inguinal hernia5. However, recent evidence advocates that orchidopexy with ligation of hernial sac is unnecessary procedure with increased occurrence of severe pain post-operatively along with increased chances of testicular atrophy due to inadvertent injury to the adjacent structures6. Furthermore, it has been found that orchidopexies without ligation of sac technique is simple, save intraoperative time and equally effective with comparable outcomes.

A recent study on orchidopexy with and without sac ligation in pediatric patients was conducted to compare mean operative time and incidence of complications including post-operative hernia A total of hundred patients were recruited in this study. In one group orchidopexy without dissection and ligation of peritoneal sac was done, while in other group included the patients in which sac ligation was performed. In this study 60 (60%) patients had left-sided whereas 40 (40%) patients had right-sided UDT. The mean operative time of the patients from no sac ligation group was 21.25±0.90 minutes whereas in ligation group 33.10±1.10 minutes. Interestingly, no case of post-operative hernia was noted in both groups (0.00%).

Rationales of the study: The surgical management of palpable undescended testes (UDT) in children involves the critical decision of whether to ligate the associated hernia sac, a step that may prolong operative time and introduce additional risks such as inflammation, infection, or tissue damage. This study aims to evaluate the impact of sac ligation on operative time and the incidence of post-operative inguinal hernias, providing a comprehensive risk-benefit analysis. By comparing the outcomes of pediatric orchiopexy with and without sac ligation, the study seeks to generate high-quality evidence to guide surgical practice, standardize care, and ultimately improve patient outcomes and healthcare resource utilization in the treatment of palpable UDT.

OBJECTIVES: To compare the outcome (in terms of operative time and occurrence of post operative inguinal hernia) of the surgery with and without sac ligation in pediatric population with palpable undescended testes.

02

Conditions studied

  • Undescended Testis

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Keywords

  • Orchiopexy
  • sac ligation
  • Palpable Undescended testis
03

In context

Cryptorchidism

40 studies on the registry are indexed under Cryptorchidism; 14 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 26 interventional studies indexed under Cryptorchidism.

Browse Cryptorchidism studies →

Lead sponsor

Children Hospital Faisalabad is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 15 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Impalpable testes
  • Staged/laparoscopic procedures,
  • Pre-op hernia,
  • History previous orchiopexy
  • Ambiguous genitalia
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Group A

    Orchiopexy with sac ligation

    Procedure: Orchiopexy with sac ligation

  • Experimental
    Group B

    Orchiopexy without sac ligation

    Procedure: Orchiopexy without sac ligation

Interventions

  • ProcedureOrchiopexy without sac ligation

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

  • ProcedureOrchiopexy with sac ligation

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

06

What researchers measure

Primary outcomes

  1. Operative Time

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

  2. Post-operative Complications

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

    Time frame: at 0, 4, 8 and 12 weeks after surgery

Secondary outcomes

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

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

  2. Post-operative Pain Score

    Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain severity.

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

07

Study locations

1 site
  • Children Hospital & Institute of Child Health
    Faisalābad, Punjab Province 38000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2024 to primary completion in Mar 2025, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2025
First posted
Jan 6, 2026
StartActual
Sep 1, 2024
Primary completionActual
Mar 1, 2025
CompletionActual
Mar 15, 2025
Last update
Jan 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07319637
Lead sponsor
Children Hospital Faisalabad
Responsible party
Rida Dawood (Postgraduate Resident, Children Hospital Faisalabad) — Principal investigator
First posted
Jan 6, 2026
Start date
Sep 1, 2024
Primary completion
Mar 1, 2025
Completion
Mar 15, 2025
Last update
Jan 6, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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