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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
transposition surgery
Procedure/SurgeryReconstructs 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/SurgeryBlocks venous reflux via double ligation and division of spermatic veins under microscopy, with identical surgical exposure and vascular protection.
Treatment groups
Trial outcomes
Primary outcomes
The effectiveness of the surgery
measuring vein diameter,anastomotic vessel patency and reflux duration by color Doppler ultrasound
Semen analysis
Semen Quality by semen analysis
Secondary outcomes
The incidence rate of postoperative complications
Mainly include bleeding, testicular artery injury, scrotal hematoma and infection
Testicular volume
Measure the size of the testicles by ultrasound
Testicular function
Determination of serum sex hormones
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
This trial is not recruiting at the moment. You can still explore other options: