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临床试验/NCT07065695
NCT07065695尚未招募不适用

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

Ke Dou1 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2025年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
284
试验地点
1
主要终点
The effectiveness of the surgery

研究概览

简要总结

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.

详细描述

This prospective, single-blind, randomized controlled trial is conducted at the Urology and Andrology Center of Sichuan Provincial People's Hospital, led by Principal Investigator Dou Ke, to evaluate the safety and efficacy of microscopic varicocele transposition surgery compared with microscopic simple ligation for treating left varicocele. The study spans from May 2025 to December 2027.

  1. Study Design Details

Randomization Process:

Utilizing a computer-generated random number table with a 1:1 allocation ratio, patients are assigned to either group. To ensure randomness, the randomization sequence is generated by an independent statistician not involved in patient enrollment or intervention delivery. Block randomization with block sizes of 4-8 will be employed to balance group sizes over time.

Blinding Implementation:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

The effectiveness of the surgery

时间窗: 1, 3, and 6 months postsurgery

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

Semen analysis

时间窗: 1, 3, and 6 months postsurgery

Semen Quality by semen analysis

次要结局

  • The incidence rate of postoperative complications(postsurgery (3, 6 months))
  • Testicular volume(postsurgery (3, 6 months))
  • Testicular function(postsurgery (3, 6 months))

研究者

发起方
Ke Dou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ke Dou

Sichuan Provincial People's Hospital

Sichuan Provincial People's Hospital

研究点 (1)

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