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
|Condition or disease||Intervention/treatment||Phase|
|Unilateral Cryptorchidism||Procedure: Single-stage Fowler-Stephens orchidopexy (FSO) Procedure: Two-stage Fowler-Stephens orchidopexy (FSO)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
- 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.
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
|Contact: Alyssia Venna, MBSfirstname.lastname@example.org|
|Contact: rachel email@example.com|
|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|
|Principal Investigator:||Caleb P Nelson, MD, MPH||Boston Children’s Hospital|