Comparison of Outcomes of Two Approaches in Microsurgical Varicocelectomy in Chinese Infertile Males: A Prospective Randomized, Controlled Trial
Condition: Varicocele
MeSH terms: Varicocele
Study type: Interventional
Phase: Phase 4

Summary: 
      Varicocele is the most common surgical disease which could lead to male infertility. It is
      found in approximately 15% adult males, and in about 40% infertile males. And the incidence
      is up to 80% in secondary infertility. In the past, there was continuous controversy over
      whether a varicocele repair could improve fertility. But at present, researches are coming to
      a consensus on the indication of varicocelectomy. Several researches manifest that the
      microsurgery of varicocele could have the effect of the highest spontaneous pregnancy and
      lowest complications rate after surgery. Microsurgical varicocelectomy includes two
      approaches, inguinal and subinguinal. Each one has its advantages and disadvantages. There
      are few studies which make direct comparison between the two methods in microsurgical
      varicocelectomy, especially in China. Operators have made decisions on the basis of their own
      experience and skills. In this study, the investigators compare the postoperative spontaneous
      pregnancy and complications rates in two approaches in microsurgical varicocelectomy for
      Chinese infertile men in their hospital.
    

Detailed description: 
      Outcome Measures

      Before surgery, all patients were diagnosed by physical examination and testified by color
      Doppler ultrasound. And one trained nurse documented the patients' age, left unilateral or
      bilateral and the grade of varicocele, and the grade of the more serious side was noted when
      handled with bilateral ones. During surgery, the duration of surgery was documented. After
      surgery, a Visual Analogue Scale (VAS) was used to assess the introperative pain after
      anesthesia recovery and the amount of postoperative pain one month postoperatively by another
      trained nurse. And the patients whose pain scores > 3 and/or who claimed pain were prescribed
      with ibuprofen sustained-release capsules (China SmithKline Pharmaceutical Company, Tianjing,
      China) (0.3g) (ISRC) every 12h on the surgical day (since 2h postoperatively) and only if
      necessary on the following days (no patient claimed that he had gastrointestinal ulcer
      history or allergic history of relative drug). Parents were told to write down on a provided
      form how many times they gave medicine postoperatively. Patients were followed with visits 1
      month, 3, 6 and 12 months after surgery, and were encouraged to visit the clinic anytime when
      they had any complaint in this period. The semen analyses were conducted in the 3, 6 and 12
      months in the follow-up. The recurrence or hydrocele formation was testified by color Doppler
      ultrasound (with/without detected by physical examination) by the same doctor who did the
      preoperative examination. And this doctor and two nurses mentioned above were all unaware of
      the patients' groups.
    

Intervention name(s): microsurgical varicocelectomy in inguinal approach; microsurgical varicocelectomy in subinguinal approach
Intervention type(s): Procedure; Procedure
Intervention description(s): In inguinal approach, the incision, which was about 3cm, was made two fingers up the pubic symphysis, from external inguinal rings parallel to the inguinal ligament.; In subinguinal approach, the incision was about 3 cm horizontal and 1 cm below the external inguinal ring.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infertility; varicocelectomy; microsurgery; Chinese men; pregnancy rate