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NOT YET RECRUITING
NCT07065695
NA

Microscopic Varicocele Bypass Versus Ligation

Sponsor: Ke Dou

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective Randomized Controlled Study on the Safety and Effectiveness of Microscopic Varicocele Bypass Surgery Compared With Simple Ligation

Key Details

Gender

MALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

284

Start Date

2025-07-22

Completion Date

2027-12-31

Last Updated

2025-07-15

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

transposition 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.

PROCEDURE

microscopic simple ligation

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

Locations (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China