66 Participants Needed

Fowler-Stephens Orchidopexy for Undescended Testicles

(ORCA Trial)

RS
BO
Overseen ByBadar Omar, BA
Age: < 18
Sex: Male
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Do I need to stop my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

How does Fowler-Stephens orchidopexy differ from other treatments for undescended testicles?

Fowler-Stephens orchidopexy is unique because it involves dividing the short testicular vessels to allow the testis to be placed in the scrotum, relying on alternative blood supply routes. It can be performed in one or two stages, which is different from other treatments that may not address the issue of short vessels in the same way.12345

What data supports the effectiveness of the treatment Fowler-Stephens orchidopexy for undescended testicles?

Research shows that both single-stage and two-stage Fowler-Stephens orchidopexy are effective for treating undescended testicles, especially when they are located high in the abdomen. Studies have compared these methods and found them to be successful in positioning the testicles correctly, with factors like testicular atrophy (shrinkage) and malpositioning being important considerations.34567

Who Is on the Research Team?

CP

Caleb P Nelson, MD, MPH

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for boys aged 4 to 36 months with one undescended testicle located in the abdomen, suitable for Fowler-Stephens Orchiopexy (FSO). It's not for those with a solitary testis, bilateral cryptorchidism, or if the testis can reach the opposite internal ring without cutting spermatic vessels.

Inclusion Criteria

My son is between 4 to 36 months old and needs surgery for an undescended testicle found in the abdomen.

Exclusion Criteria

I am older than 3 years.
Both of my testicles have not descended.
My testis can be moved to the opposite side during surgery without cutting its blood supply.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a single-stage or two-stage Fowler-Stephens orchidopexy to fix an undescended testicle

6-12 months
2 surgeries for two-stage group, 1 surgery for single-stage group

Follow-up

Participants are monitored for testicular outcomes using scrotal ultrasound

6-12 months
1 visit (in-person) for ultrasound

What Are the Treatments Tested in This Trial?

Interventions

  • Single-stage Fowler-Stephens orchidopexy (FSO)
  • Two-stage Fowler-Stephens orchidopexy (FSO)
Trial Overview The study compares two surgical methods to correct an undescended testicle: Single-stage and Two-stage Fowler-Stephens orchidopexy. Outcomes are measured by scrotal ultrasound post-surgery and include cost analysis, complication rates, and quality of life impacts.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)Experimental Treatment1 Intervention
Group II: Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Published Research Related to This Trial

In a study of 94 children undergoing laparoscopic second-stage Fowler-Stephens orchidopexy, 83.3% of the testicles had a successful outcome, indicating that this surgical method is generally effective for treating intra-abdominal testes.
Testicular atrophy and ascent occurred in 8.8% of cases each, with no significant differences based on whether the testes were unilateral or bilateral, suggesting that the procedure has a relatively low risk of complications.
Testicular outcome following laparoscopic second stage Fowler-Stephens orchidopexy.Alagaratnam, S., Nathaniel, C., Cuckow, P., et al.[2014]
In a study of 85 patients with intra-abdominal undescended testes, the staged Fowler-Stephens (SFS) procedure resulted in no cases of abnormally positioned testes postoperatively, while 20% of patients who underwent single-stage laparoscopic orchiopexy (SSLO) experienced malpositioning.
Both surgical approaches showed similar rates of testicular atrophy, indicating that while SFS may provide better positioning outcomes, it does not significantly differ from SSLO in terms of atrophy risk.
Staged Fowler-Stephens and Single-stage Laparoscopic Orchiopexy for Intra-abdominal Testes: Is There a Difference? A Single Institution Experience.Alam, A., Delto, JC., Blachman-Braun, R., et al.[2018]
In a review of 20 patients who underwent 22 Fowler-Stephens orchidopexies (FSO) over a period from 1978 to 1999, 82% of the testes were successfully placed in the scrotum, indicating a high success rate for this procedure.
The mean follow-up period was 22 months, suggesting that the long-term outcomes of the FSO are comparable to other surgical options for managing high maldescended testes.
One-stage Fowler-Stephens orchidopexy for impalpable undescended testis.O'Brien, MF., Hegarty, PK., Healy, C., et al.[2019]

Citations

Testicular outcome following laparoscopic second stage Fowler-Stephens orchidopexy. [2014]
Staged Fowler-Stephens and Single-stage Laparoscopic Orchiopexy for Intra-abdominal Testes: Is There a Difference? A Single Institution Experience. [2018]
One-stage Fowler-Stephens orchidopexy for impalpable undescended testis. [2019]
Retrospective analysis of testicular outcomes following laparoscopic two-stage Fowler Stephens orchidopexy. [2020]
Evaluation of Fowler-Stephens orchiopexy for high-level intra-abdominal cryptorchidism: A systematic review and meta-analysis. [2019]
Efficacy of single-stage and two-stage Fowler-Stephens laparoscopic orchidopexy in the treatment of intraabdominal high testis. [2018]
Laparoscopy for the impalpable testes: experience with 80 intra-abdominal testes. [2022]
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