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Orchidopexy Randomized Clinical Assessment (ORCA)

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ClinicalTrials.gov Identifier: NCT02235623
Recruitment Status : Recruiting
First Posted : September 10, 2014
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Caleb Nelson, Boston Children’s Hospital

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).

Condition or disease Intervention/treatment Phase
Unilateral Cryptorchidism Procedure: Single-stage Fowler-Stephens orchidopexy (FSO) Procedure: Two-stage Fowler-Stephens orchidopexy (FSO) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis
Study Start Date : August 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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.
Procedure: Single-stage Fowler-Stephens orchidopexy (FSO)
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.
Procedure: Two-stage Fowler-Stephens orchidopexy (FSO)



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   4 Months to 36 Months   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235623


Contacts
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Contact: Alyssia Venna, MBS 617-919-6352 alyssia.venna@childrens.harvard.edu
Contact: rachel saunders rachel.saunders@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Alyssia Venna, MBS    617-919-6352    Alyssia.Venna@childrens.harvard.edu   
Principal Investigator: Caleb P Nelson, MD, MPH         
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Caleb P Nelson, MD, MPH Boston Children’s Hospital
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Responsible Party: Caleb Nelson, Caleb Nelson, MD MPH, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02235623    
Other Study ID Numbers: P00008033
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Keywords provided by Caleb Nelson, Boston Children’s Hospital:
Laparoscopic Surgery
Orchiopexy
Additional relevant MeSH terms:
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Cryptorchidism
Testicular Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases