NCT07353164

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

January 9, 2026

Last Update Submit

January 15, 2026

Conditions

Varicocele

Keywords

VaricocelectomyHigh ligationOpen surgeryLaparoscopic surgeryPostoperative wound infection

Outcome Measures

Primary Outcomes (1)

  • Mean operative time

    Operative time was measured in minutes from skin incision until completion of skin closure (stitching).

    During the surgery

Secondary Outcomes (2)

  • Length of hospital stay

    Up to 30 days post-surgery

  • Wound infection rate

    10 days after surgery

Study Arms (2)

Group A (Open high ligation varicocelectomy)

EXPERIMENTAL

Open high ligation varicocelectomy

Procedure: Open high ligation varicocelectomy

Group B (Laparoscopic high ligation varicocelectomy)

ACTIVE COMPARATOR

Laparoscopic high ligation varicocelectomy

Procedure: Laparoscopic high ligation varicocelectomy

Interventions

Laparoscopic high ligation varicocelectomyPROCEDURE

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.

Group B (Laparoscopic high ligation varicocelectomy)
Open high ligation varicocelectomyPROCEDURE

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.

Group A (Open high ligation varicocelectomy)

Eligibility Criteria

Age20 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male patients age 20-60 years.
  • Patients with varicocele.
  • Planned to undergo varicocelectomy under general anesthesia.

You may not qualify if:

  • Patients with recurrent varicocele.
  • Secondary varicocele.
  • Associated undescended testis or history of orchidopexy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

VaricoceleSurgical Wound Infection

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular DiseasesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Zeshan Aziz

    Lahore General Hospital, Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 20, 2026

Study Start

September 1, 2024

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

PA(1)