A Phase 4 interventional study of microsurgical varicocelectomy in inguinal approach and microsurgical varicocelectomy in subinguinal approach in Varicocele, sponsored by Feng Pan. Completed at 1 site in China. Open to male participants aged 20 Years to 46 Years. Per ClinicalTrials.gov, last updated 2013-04-10.
Sponsored by Feng Pan · Phase 4, Interventional, and Treatment
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.
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.
53 studies on the registry are indexed under Varicocele; 15 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 36 interventional studies indexed under Varicocele.
Browse Varicocele studies →Feng Pan is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Procedure: microsurgical varicocelectomy in inguinal approach
Procedure: microsurgical varicocelectomy in subinguinal approach
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.
pregnancy
Postoperative spontaneous pregnancy is considered to be the best indicator to assess fertility status.
Time frame: within the 12-24 months postoperative period
The record gives a start of Jan 2009, a primary completion of Dec 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Feng Pan