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NCT Number: NCT02235623

Orchidopexy Randomized Clinical Assessment

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).

Recruiting

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Key information

Conditions

Unilateral Cryptorchidism Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cryptorchidism Endocrine System Diseases Genital Diseases Genital Diseases, Male Gonadal Disorders Male Urogenital Diseases Testicular Diseases Urogenital Abnormalities Urogenital Diseases

Age range

4 month–36 month

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Badar Omar, BA

CONTACT

[email protected]

617-919-6354

Caleb P Nelson, MD, MPH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single-stage Fowler-Stephens orchidopexy (FSO)

Procedure

Two-stage Fowler-Stephens orchidopexy (FSO)

Procedure

Primary outcomes

  1. To evaluate the volume of the operated testis via ultrasound measurements.

    Time frame: 6-12 months after final FSO surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Badar Omar, BA

CONTACT

[email protected]

617-919-6352

Vera Rodic, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis

Acronym: ORCA

Important dates

Study start
2014
Primary completion
2030
Study completion
2030
First posted
Sep 10, 2014
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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