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临床试验/NCT01259258
NCT01259258已完成2 期

Dye Assisted Lymphatic Sparing Varicocelectomy,Prospective Randomized Study

Mansoura University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
80
试验地点
2
主要终点
postoperative complication

研究概览

简要总结

We prospectively compared outcomes of subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation with 40 controls in whom no mapping technique was adopted in the period between January 2008 and Feb. 2010, in Mansoura university hospital ward 7.After surgery, the patients were assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele formation, atrophy, pain or other complications with mean follow up was 15+ 7months.

详细描述

Methods. We prospectively compared outcomes of subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation with 40 controls in whom no mapping technique was adopted in the period between January 2008 and Feb. 2010, in Mansoura university hospital ward 7.After surgery, the patients were assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele formation, atrophy, pain or other complications with mean follow up was 15+ 7months.

Results: There were no intraoperative complications in either group. There were no adverse reactions, scrotal haematomas or atrophy. In group 1, no patient had a hydrocele at 3 months after surgery. By contrast, in group 2 (surgery alone) there were four cases of secondary hydrocele (10%; P=0.025)); no testicular hypertrophy was observed following lymphatic sparing surgery , One patient in each group had varicocele recurrence. Pregnancy was reported in 30 patients (37.5%) during a follow up period, 17 of them (42.5%) were group(1),P >0.34. difference was not significantly different among the two groups

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
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • all left sided varicocele with impaired sperm counts, testicular pain and/or testicular atrophy

排除标准

  • were preexisting hydrocele, previous groin surgery, concomitant hernia, allergy against methylene blue

结局指标

主要结局

postoperative complication

时间窗: 30 days

hydrocele

次要结局

  • recurrence, pregnancy, semen parameter(one year)

研究者

申办方类型
Other

研究点 (2)

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