Microscopic Varicocele Bypass Versus Ligation

ConditionVaricocele
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-60
SponsorKe Dou

About this trial

This study, titled "A Prospective Randomized Controlled Study on the Safety and Efficacy of Microscopic Varicocele Transposition Surgery Compared with Simple Ligation," is conducted by the Urology and Andrology Department of Sichuan Provincial People's Hospital, with Dou Ke serving as the principal investigator. The research period spans from May 2025 to December 2027. It aims to compare the outcomes of microscopic varicocele transposition surgery and simple ligation in treating left varicocele through a prospective randomized controlled trial, focusing on postoperative recovery, complications, semen quality, and other aspects to provide evidence for clinical surgical selection.

A total of 284 male patients will be enrolled, meeting criteria including clinical diagnosis of varicocele with surgical indications, aged 18-60 years, willing to participate and signing informed consent, abnormal semen analysis related to varicocele, no severe organ dysfunction, and no relevant treatments affecting the condition in the past three months. Exclusions include secondary varicocele, severe genitourinary or systemic diseases, coagulation disorders, drug allergies, mental/cognitive impairments, and participation in other related clinical trials. The experimental group will receive microscopic varicocele transposition surgery, while the control group will undergo microscopic simple ligation. Primary evaluation indicators include changes in spermatic vein diameter, reflux velocity, and duration assessed by color Doppler ultrasound at 1, 3, and 6 months post-surgery (with additional measurements of anastomotic vessel diameter and flow velocity in the experimental group), as well as pre- and post-surgery (3 and 6 months) semen routine parameters. Secondary indicators surgical success rate, postoperative complication rate, changes in reproductive hormone levels, pain relief evaluated by VAS scale, and quality of life improvements via specific assessment tools. Complying with the Declaration of Helsinki and approved by the ethics committee, informed consent will be obtained from all participants. Study results will be disseminated through academic papers, conference presentations, clinical research reports, and patient-focused summaries to advance new treatment directions for varicocele and optimize clinical protocols.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with varicocele and meet the surgical indications

Male patients aged between 18 and 60 years old

Patients have the willingness to receive treatment, voluntarily participate in this study and sign the informed consent form

Semen analysis reveals abnormalities associated with varicocele

Disqualifiers

Secondary varicocele

Complicated with other severe reproductive system diseases

Suffering from severe systemic diseases, which may affect the surgical effect or prognosis

Presence of coagulation dysfunction or taking medications that affect coagulation function

Trial design

Design model

Parallel

Treatments tested in this trial

  • transposition surgery

    Procedure/Surgery

    Reconstructs spermatic vein drainage via end to side/end to end anastomosis with vessels (e.g., inferior epigastric vein) under 8-15× magnification, preserving testicular arteries/lymphatics.

  • microscopic simple ligation

    Procedure/Surgery

    Blocks venous reflux via double ligation and division of spermatic veins under microscopy, with identical surgical exposure and vascular protection.

Treatment groups

284 Participants
are divided into 2 treatment groups
Group A: transposition surgeryExperimental treatment 1 intervention
Group B: simple ligationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The effectiveness of the surgery

measuring vein diameter,anastomotic vessel patency and reflux duration by color Doppler ultrasound

Time frame
1, 3, and 6 months postsurgery
2

Semen analysis

Semen Quality by semen analysis

Time frame
1, 3, and 6 months postsurgery

Secondary outcomes

1

The incidence rate of postoperative complications

Mainly include bleeding, testicular artery injury, scrotal hematoma and infection

Time frame
postsurgery (3, 6 months)
2

Testicular volume

Measure the size of the testicles by ultrasound

Time frame
postsurgery (3, 6 months)
3

Testicular function

Determination of serum sex hormones

Time frame
postsurgery (3, 6 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ke Dou

Lead sponsor

Sichuan Provincial People's Hospital

Sponsor institution

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