VaricoceleNCT07353164
Comparison of Open Versus Laparoscopic High Ligation Varicocelectomy For The Treatment Of Varicocele
A study testing Open high ligation varicocelectomy and Laparoscopic high ligation varicocelectomy in people with Varicocele, run by Lahore General Hospital at 1 site in Pakistan.
Trial summary
Varicocele is a common condition in which veins around the testis become enlarged, and it may be associated with scrotal discomfort and reduced fertility. Surgical treatment aims to stop the backward flow of blood in these veins so that the testicular environment improves. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- Open high ligation varicocelectomy and Laparoscopic high ligation varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2024to 30 Nov 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 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients age 20-60 years.
- Patients with varicocele.
- Planned to undergo varicocelectomy under general anesthesia.
Who cannot join
- Patients with recurrent varicocele.
- Secondary varicocele.
- Associated undescended testis or history of orchidopexy.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore General Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
Varicocele is a common condition in which veins around the testis become enlarged, and it may be associated with scrotal discomfort and reduced fertility. Surgical treatment aims to stop the backward flow of blood in these veins so that the testicular environment improves. This randomized controlled trial was conducted in the Department of Urology, PGMI, Lahore General Hospital, Lahore, over a six-month period.
Male patients aged 20 to 60 years with diagnosed varicocele and planned varicocelectomy under general anesthesia were enrolled after informed consent. Patients with recurrent varicocele, secondary varicocele, associated undescended testis, or a history of orchidopexy were excluded. Eligible participants were allocated into two groups using a lottery method. In Group A, high ligation was performed by the open method through a lower abdominal incision, with identification and ligation of the dilated testicular veins at a high level. In Group B, high ligation was performed laparoscopically using three small ports, with the testicular vein identified, clipped, and divided. Standard perioperative care was provided, including intravenous antibiotics and postoperative analgesia.
The study compared the two techniques in terms of mean operation time , length of hospital stay , and wound infection . The hypothesis was that a difference existed between open and laparoscopic high ligation varicocelectomy regarding operation time, hospital stay, and wound infection.
- Conditions
- Varicocele
- Being tested
- Open high ligation varicocelectomy, Laparoscopic high ligation varicocelectomy
- Keywords
- Varicocelectomy, High ligation, Open surgery, Laparoscopic surgery, Postoperative wound infection
- Medical subject headings
- Varicocele, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open high ligation varicocelectomyProcedure or surgery
High ligation of the dilated testicular veins was performed by an open approach through a lower abdominal incision. The spermatic cord structures were approached extraperitoneally, the testicular vein was identified, separated from the artery after identification, and divided with ligatures. Wound closure was performed in layers with absorbable sutures and skin closure with silk sutures.
Laparoscopic high ligation varicocelectomyProcedure or surgery
High ligation of the testicular vein was performed laparoscopically by inserting three ports. The testicular vessels were approached intraperitoneally, the testicular vein was identified, clipped, and divided. Wound closure was performed using absorbable suture material, with skin closure using silk sutures.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Open high ligation varicocelectomy) | Experimental | Open high ligation varicocelectomy Receives: Procedure: Open high ligation varicocelectomy |
| Group B (Laparoscopic high ligation varicocelectomy) | Active comparator | Laparoscopic high ligation varicocelectomy Receives: Procedure: Laparoscopic high ligation varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean operative time
Operative time was measured in minutes from skin incision until completion of skin closure (stitching).
Measured: During the surgery
Secondary outcomes (2)
Length of hospital stay
Hospital stay was measured in days from the day of surgery until discharge from the hospital.
Measured: Up to 30 days post-surgery
Wound infection rate
Wound infection was assessed at 10 days after surgery with confirmation by positive pus culture when discharge was present.
Measured: 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Sep 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Irfan Jamil, Lahore General Hospital
- Investigators
- Muhammad Zeshan Aziz, Principal investigator, Lahore General Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353164
- Sponsor's protocol ID
- LahoreGeneralH13
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Open Versus Laparoscopic High Ligation Varicocelectomy For The Treatment Of Varicocele
- ClinicalTrials.gov ID
- NCT07353164
- Acronym / sponsor ID
- LahoreGeneralH13
- Conditions
- Varicocele
- Keywords
- Varicocelectomy, High ligation, Open surgery, Laparoscopic surgery, Postoperative wound infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 20 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.
Varicocele is a common condition in which veins around the testis become enlarged, and it may be associated with scrotal discomfort and reduced fertility. Surgical treatment aims to stop the backward flow of blood in these veins so that the testicular environment improves. This randomized controlled trial was conducted in the Department of Urology, PGMI, Lahore General Hospital, Lahore, over a six-month period.
Male patients aged 20 to 60 years with diagnosed varicocele and planned varicocelectomy under general anesthesia were enrolled after informed consent. Patients with recurrent varicocele, secondary varicocele, associated undescended testis, or a history of orchidopexy were excluded. Eligible participants were allocated into two groups using a lottery method. In Group A, high ligation was performed by the open method through a lower abdominal incision, with identification and ligation of the dilated testicular veins at a high level. In Group B, high ligation was performed laparoscopically using three small ports, with the testicular vein identified, clipped, and divided. Standard perioperative care was provided, including intravenous antibiotics and postoperative analgesia.
The study compared the two techniques in terms of mean operation time , length of hospital stay , and wound infection . The hypothesis was that a difference existed between open and laparoscopic high ligation varicocelectomy regarding operation time, hospital stay, and wound infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Open high ligation varicocelectomy) | Experimental | Procedure: Open high ligation varicocelectomyOpen high ligation varicocelectomy |
| Group B (Laparoscopic high ligation varicocelectomy) | Active comparator | Procedure: Laparoscopic high ligation varicocelectomyLaparoscopic high ligation varicocelectomy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male patients age 20-60 years.
- Patients with varicocele.
- Planned to undergo varicocelectomy under general anesthesia.
Key exclusion criteria (3 listed)
- Patients with recurrent varicocele.
- Secondary varicocele.
- Associated undescended testis or history of orchidopexy.
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 |
|---|---|---|
| Open high ligation varicocelectomyHigh ligation of the dilated testicular veins was performed by an open approach through a lower abdominal incision. The spermatic cord structures were approached extraperitoneally, the testicular vein was identified, separated from the artery after identification, and divided with ligatures. Wound closure was performed in layers with absorbable sutures and skin closure with silk sutures. | Procedure or surgery | Group A (Open high ligation varicocelectomy) |
| Laparoscopic high ligation varicocelectomyHigh ligation of the testicular vein was performed laparoscopically by inserting three ports. The testicular vessels were approached intraperitoneally, the testicular vein was identified, clipped, and divided. Wound closure was performed using absorbable suture material, with skin closure using silk sutures. | Procedure or surgery | Group B (Laparoscopic high ligation varicocelectomy) |
Primary outcome
Mean operative time
Time frame: During the surgery
Operative time was measured in minutes from skin incision until completion of skin closure (stitching).
2 secondary outcomes
Length of hospital stay
Time frame: Up to 30 days post-surgery
Wound infection rate
Time frame: 10 days 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 20 Jan 2026.
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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.
Muhammad Zeshan Aziz principal investigator
Lahore General Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open high ligation varicocelectomy and Laparoscopic high ligation varicocelectomy in people with Varicocele, run by Lahore General Hospital 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 3 inclusion and 3 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 20 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?
Mean operative time (time frame: During the surgery). 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 20 Jan 2026.