An interventional study of Single-stage Fowler-Stephens orchidopexy (FSO) and Two-stage Fowler-Stephens orchidopexy (FSO) in Unilateral Cryptorchidism, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to male participants aged 4 Months to 36 Months. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
This is a randomized trial designed to evaluate testicular outcomes after a single stage versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in the abdomen. Also to determine and compare the costs, surgical complications and the health related quality of life for the two procedures. Testicular outcomes will be measured using a scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for those randomized to a 2 stage surgery).
40 studies on the registry are indexed under Cryptorchidism; 14 are open to participants now.
This study's planned enrollment of 66 is close to the median of 70 across 26 interventional studies indexed under Cryptorchidism.
Browse Cryptorchidism studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum.
Procedure: Single-stage Fowler-Stephens orchidopexy (FSO)
Stage 2 2 surgeries: 1st surgery-Clip vessels to testis. 2nd surgery done 6-12 months later, divide the spermatic vessels and bring the testis into the scrotum.
Procedure: Two-stage Fowler-Stephens orchidopexy (FSO)
To evaluate the volume of the operated testis via ultrasound measurements.
To evaluate the volume of the operated testis at 6-12 months after single-stage Fowler-Stephens orchidopexy (FSO) (6-12 months after two- stage FSO), as determined by ultrasound measurements. This will be compared to the intra-operative testicular measurements done during the laparoscopy.
Time frame: 6-12 months after final FSO surgery
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