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.
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
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.
- Conditions
- Undescended Testis
- 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 group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Orchiopexy with sac ligation Receives: Procedure: Orchiopexy with sac ligation |
| Group B | Experimental | Orchiopexy 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.
Operative Time
Measured: 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
Measured: at 0, 4, 8 and 12 weeks after surgery
Secondary outcomes (2)
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)
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.
- First posted6 Jan 2026
- Study start1 Sep 2024
- Primary completion1 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undescended TestisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Children Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rida Dawood, Children Hospital Faisalabad
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Outcome of Orchidopexy With and Without Sac Ligation in Paediatric Population With Palpable Undescended Testis
- ClinicalTrials.gov ID
- NCT07319637
- Acronym / sponsor ID
- CPSP/REU/PSG-2023-290-572
- Conditions
- Undescended Testis
- Keywords
- Orchiopexy, sac ligation, Palpable Undescended testis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children Hospital FaisalabadUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Orchiopexy with sac ligationOrchiopexy with sac ligation |
| Group B | Experimental | Procedure: Orchiopexy without sac ligationOrchiopexy without sac ligation |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male children ≤15 years with palpable UDT
- Scheduled for single stage orchidopexy
Key exclusion criteria (5 listed)
- Impalpable testes
- Staged/laparoscopic procedures,
- Pre-op hernia,
- History previous orchiopexy
- Ambiguous genitalia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orchiopexy without sac ligationTo compare the outcome of the surgery with and without sac ligation in pediatric population with palpable undescended testes. | Procedure or surgery | Group B |
| Orchiopexy with sac ligationTo compare the outcome of the surgery with and without sac ligation in pediatric population with palpable undescended testes. | Procedure or surgery | Group A |
Primary outcome
Operative Time
Time frame: During surgery "from skin incision to skin closure", assessed at the time of the surgical procedure.
Post-operative Complications
Time frame: at 0, 4, 8 and 12 weeks after surgery
Post-op hernia, Wound infection, Hematoma and Testicular atrophy
2 secondary outcomes
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)
Post-operative Pain Score
Time frame: Post-operative period, assessed at 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Undescended Testis
Active, not recruitingObservational study
INVESTIGATION OF THE GENETIC ETIOLOGY OF HERNIA SAC DEVELOPMENT IN MALE CHILDREN WITH UNDESCENDED TESTIS AND INGUINAL HERNIA
Indirect Inguinal Hernia, Undescended Testis
Recruiting
Orchidopexy Randomized Clinical Assessment
Unilateral Cryptorchidism
Recruiting
Transection Versus Ligation of Internal Spermatic Vessels in Laparoscopic Fowler-Stephens Orchidopexy
Cryptorchidism
Recruiting
Comparison of Single Incision Scrotal vs Standard Two Incision Inguinal Orchidopexy in Children Under 10 Years.
Undescended Testis
RecruitingObservational study
Role of the Environment and Endocrine Disruptors in Child Cryptorchidism
Cryptorchidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.