Microscopic Varicocele Bypass Versus Ligation

NCT07065695 | Not Yet Recruiting

• 1 other identifier: 2025358
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Varicocele

Keywords

Varicocele; microscopic simple ligation; transposition surgery

Outcome Measures

Primary Outcomes (2)

• The effectiveness of the surgery

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

  1, 3, and 6 months postsurgery

• Semen analysis

  Semen Quality by semen analysis

  1, 3, and 6 months postsurgery

Secondary Outcomes (3)

• The incidence rate of postoperative complications

  postsurgery (3, 6 months)

• Testicular volume

  postsurgery (3, 6 months)

• Testicular function

  postsurgery (3, 6 months)

Study Arms (2)

transposition surgery

EXPERIMENTAL

Reconstructs spermatic vein drainage via end to end anastomosis with inferior epigastric vein

Procedure: transposition surgery

simple ligation

ACTIVE COMPARATOR

Blocks venous reflux via double ligation and division of spermatic veins under microscopy

Procedure: microscopic simple ligation

Interventions

transposition surgery PROCEDURE

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.

transposition surgery

microscopic simple ligation PROCEDURE

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

simple ligation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Since this study is aimed at patients with varicocele, only males will be included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• The patient has no severe dysfunction of vital organs and can tolerate surgery
• The patient has received no relevant treatment affecting varicocele or semen quality in the past three months

You may not qualify if:

• 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
• Having a history of allergy to the drugs used in the surgery
• Having mental illness or cognitive impairment and being unable to cooperate to complete this study
• Having already participated in other relevant clinical trials.

Sponsors & Collaborators

• Ke Dou: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ke Dou, Ph.D

CONTACT

+862888132132; wangjiaa0420@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sichuan Provincial People's Hospital

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: July 15, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)