Comparison of Outcomes of Two Approaches in Microsurgical Varicocelectomy in Chinese Infertile Males: A Prospective Randomized, Controlled Trial
|Varicocele||Procedure: microsurgical varicocelectomy in inguinal approach Procedure: microsurgical varicocelectomy in subinguinal approach||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
- pregnancy [ Time Frame: within the 12-24 months postoperative period ]Postoperative spontaneous pregnancy is considered to be the best indicator to assess fertility status.
|Study Start Date:||January 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Experimental: inguinal group||
Procedure: microsurgical varicocelectomy in inguinal 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.
|Active Comparator: sub-inguinal group||
Procedure: microsurgical varicocelectomy in subinguinal approach
In subinguinal approach, the incision was about 3 cm horizontal and 1 cm below the external inguinal ring.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463787
|Nanjing Maternity and Child Healthcare Hospital Affiliated to Nanjing Medical University|
|Nanjing, Jiangsu, China, 210004|