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Undescended TestisNCT07319637

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

A study testing Orchiopexy without sac ligation and Orchiopexy with sac ligation in people with Undescended Testis, run by Children Hospital Faisalabad at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 months to 15 years, men only
Conditions the study is for
Undescended Testis
What is being tested?
Orchiopexy without sac ligation and Orchiopexy with sac ligation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
1 Sep 2024to 15 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 15 years
  • Men only
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Children Hospital & Institute of Child Health

    Faisalābad, Punjab Province, 38000

Other trials in Pakistan

About this study

Official title: Comparison of the Outcome of Orchidopexy With and Without Sac Ligation in Paediatric Population With Palpable Undescended Testis

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.

Being tested
Orchiopexy without sac ligation, Orchiopexy with sac ligation
Keywords
Orchiopexy, sac ligation, Palpable Undescended testis
Medical subject headings
Cryptorchidism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orchiopexy without sac ligationProcedure or surgery

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

  • Orchiopexy with sac ligationProcedure or surgery

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

Study groups in NCT07319637
Study groupRoleWhat they receive
Group AActive comparatorOrchiopexy with sac ligation
Receives: Procedure: Orchiopexy with sac ligation
Group BExperimentalOrchiopexy without sac ligation
Receives: Procedure: Orchiopexy without sac ligation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operative Time

    Measured: 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

    Measured: at 0, 4, 8 and 12 weeks after surgery

Secondary outcomes (2)
  1. Hospital stay duration, or Length of Stay (LOS) in the hospital

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start1 Sep 2024
  3. Primary completion1 Mar 2025
  4. Study completion15 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07319637
Sponsor's protocol ID
CPSP/REU/PSG-2023-290-572
Other IDs
No.32/CH&ICH/FSD, 16-Jan-2024
Status last verified
Dec 2025
First submitted
9 Dec 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Orchiopexy without sac ligation and Orchiopexy with sac ligation in people with Undescended Testis, run by Children Hospital Faisalabad at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operative Time (time frame: During surgery "from skin incision to skin closure", assessed at the time of the surgical procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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