- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07353164
Comparison of Open Versus Laparoscopic High Ligation Varicocelectomy For The Treatment Of Varicocele
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Lahore General Hospital, Lahore
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male patients age 20-60 years.
- Patients with varicocele.
- Planned to undergo varicocelectomy under general anesthesia.
Exclusion Criteria:
- Patients with recurrent varicocele.
- Secondary varicocele.
- Associated undescended testis or history of orchidopexy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (Open high ligation varicocelectomy)
Open high ligation varicocelectomy
|
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.
|
|
Active Comparator: Group B (Laparoscopic high ligation varicocelectomy)
Laparoscopic high ligation varicocelectomy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean operative time
Time Frame: During the surgery
|
Operative time was measured in minutes from skin incision until completion of skin closure (stitching).
|
During the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of hospital stay
Time Frame: Up to 30 days post-surgery
|
Hospital stay was measured in days from the day of surgery until discharge from the hospital.
|
Up to 30 days post-surgery
|
|
Wound infection rate
Time Frame: 10 days after surgery
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Wound infection was assessed at 10 days after surgery with confirmation by positive pus culture when discharge was present.
|
10 days after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Zeshan Aziz, Lahore General Hospital, Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LahoreGeneralH13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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