Recruiting

Orchidopexy

Sponsor:

Boston Children's Hospital

Code:

NCT02235623

Conditions

Unilateral Cryptorchidism

Eligibility Criteria

Sex: Male

Age: 0 - 3

Healthy Volunteers: Not accepted

Interventions

Single-stage Fowler-Stephens orchidopexy (FSO)

Two-stage Fowler-Stephens orchidopexy (FSO)

Study Details

Brief summary:

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).

Conditions

Unilateral Cryptorchidism

Study ID

NCT02235623

Start date

Aug, 2014

Status verified date

Apr, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0 - 3

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Boys age 4 months to 36 months
  • Undergoing diagnostic laparoscopy for unilateral non-palpable testis, who are found at laparoscopy to have an abdominal undescended testis, in whom a Fowler-Stephens Orchiopexy would be appropriate.

Exclusion Criteria:

  • Age > 36 months
  • Age < 4 months
  • Bilateral cryptorchidism
  • Solitary testis
  • Findings at laparoscopy for which Fowler-Stephens Orchiopexy would not be indicated
  • Intra-operative mobility of the intra-abdominal testis such that, with no (or minimal) mobilization, the testis is able to reach the contralateral internal ring, without dividing the spermatic vessels.
  • Assessment of whether a single stage primary orchidopexy will be performed, is entirely at the discretion of the attending surgeon.

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)

Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum.

other: Stage 2- Two-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.

Interventions

Single-stage Fowler-Stephens orchidopexy (FSO)

Two-stage Fowler-Stephens orchidopexy (FSO)

Primary outcome measure

  • To evaluate the volume of the operated testis via ultrasound measurements. [ Time Frame: 6-12 months after final FSO surgery ]

Central Contacts and Locations

Central contacts

Badar Omar, BA

617-919-6352Badar.Omar@childrens.harvard.edu

Vera Rodic, MPH

Vera.Rodic@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Badar Omar, BA

617-919-6354Badar.Omar@childrens.harvard.edu

Principal Investigator:

Caleb P Nelson, MD, MPH

More Information

Sponsor

Boston Children's Hospital

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • Laparoscopic Surgery
  • Orchiopexy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-04-15.