Fowler-Stephens Orchidopexy for Undescended Testicles

(ORCA Trial)

Overseen By Badar Omar, BA

Age: < 18

Sex: Male

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Age > 36 months, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6-12 months

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical methods for correcting an undescended testicle located in the abdomen: single-stage Fowler-Stephens orchidopexy (FSO) and two-stage Fowler-Stephens orchidopexy (FSO). It examines the outcomes of one surgery versus two, focusing on effectiveness, costs, and complications. Boys aged 4 to 36 months with an abdominal undescended testicle, who qualify for this surgery, may be suitable candidates for the trial. Follow-up checks using ultrasound will assess the surgery's effectiveness. As an unphased trial, this study allows participants to contribute to valuable research that could enhance surgical outcomes for future patients.

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.

What prior data suggests that these surgical procedures are safe for treating undescended testicles?

Research has shown that both single-stage and two-stage Fowler-Stephens orchidopexy (FSO) surgeries are generally safe for treating undescended testicles. In the two-stage approach, studies found that testicle atrophy occurs in 11% to 37% of cases, depending on the center. Although these figures aren't ideal, they provide insight into potential outcomes, even if they exceed some expectations.

For the single-stage surgery, other studies indicated that the two-stage method had a higher success rate, suggesting it might be safer in certain situations. However, both methods are used in practice, and serious complications are rare. This indicates that while some risk exists, these procedures are generally well-tolerated in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Fowler-Stephens orchidopexy for undescended testicles because it offers a strategic approach to bring the testis into the scrotum effectively. Unlike traditional orchidopexy, which typically involves a straightforward surgical relocation, the Fowler-Stephens technique involves clipping the vessels to the testis, which helps in preserving blood supply and potentially improving outcomes. The single-stage procedure is done in one surgery, making it potentially quicker for recovery, while the two-stage procedure allows for a more gradual process, possibly reducing the risk of complications. This innovative approach gives surgeons more flexibility and could lead to better long-term results for patients.

What evidence suggests that this trial's treatments could be effective for undescended testicles?

This trial will compare the effectiveness of single-stage and two-stage Fowler-Stephens orchidopexy for moving an undescended testicle into the scrotum. Research has shown that both procedures are effective. One study found that about 83.3% of testicles treated with the two-stage procedure were successfully moved, with low rates of shrinkage. Another study suggested that the two-stage procedure generally has a higher success rate and less shrinkage compared to the one-stage procedure. However, single-stage surgeries remain effective, especially when the testicle is not too high in the abdomen. Overall, these surgeries are reliable methods for treating undescended testicles. ^{2 3 4 6 7}

Who Is on the Research Team?

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

Both of my testicles have not descended.

I am older than 3 years.

My testis can be moved to the opposite side during surgery without cutting its blood supply.

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?

Group I: Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO) Experimental Treatment 1 Intervention

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.

Group II: Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

A systematic review of 60 studies involving 1991 testes found that both 1-stage and 2-stage Fowler-Stephens orchiopexy (FSO) had high success rates (85% and 87%, respectively) and acceptable atrophy rates (10% for both).

The analysis indicated that 2-stage laparoscopic FSO is the most effective approach for treating high-level intra-abdominal testes, showing the highest success rate (89%) and the lowest atrophy rate (8%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Fowler-Stephens orchiopexy for high-level intra-abdominal cryptorchidism: A systematic review and meta-analysis. Yu, C., Long, C., Wei, Y., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-stage Fowler-Stephens orchidopexy for impalpable undescended testis. O'Brien, MF., Hegarty, PK., Healy, C., et al.[2019]

In a study of 114 children undergoing laparoscopic two-stage Fowler Stephens orchidopexy (LFSO) for impalpable testes, 85% of the testes had successful outcomes, with only 8.3% experiencing atrophy and 6.3% ascending after the procedure.

While no significant predictive factors for success were identified, there was a trend suggesting that preserving the gubernaculum during surgery may lower the risk of testicular atrophy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of testicular outcomes following laparoscopic two-stage Fowler Stephens orchidopexy. Roy, C., Cullis, PS., Clark, C., et al.[2020]

In a study of 111 boys with 132 impalpable testes, the two-stage laparoscopic Fowler-Stephens orchidopexy achieved an overall success rate of 80% for intra-abdominal testes, indicating it is an effective surgical intervention.

Younger age at operation, particularly in boys with bilateral intra-abdominal testes, was associated with higher success rates, suggesting that earlier intervention may improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopy for the impalpable testes: experience with 80 intra-abdominal testes. Hvistendahl, GM., Poulsen, EU.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testicular outcome following laparoscopic second stage Fowler-Stephens orchidopexy. Alagaratnam, S., Nathaniel, C., Cuckow, P., et al.[2014]

In a study of 28 patients undergoing laparoscopic orchidopexy for intraabdominal high testis, single-stage and two-stage Fowler-Stephens procedures showed no significant differences in testicular volume, hormone levels, or postoperative testicular position, indicating similar efficacy and safety.

The single-stage procedure is recommended as the preferred option when conditions allow, as it may reduce costs and postoperative pain compared to the two-stage approach, without compromising outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of single-stage and two-stage Fowler-Stephens laparoscopic orchidopexy in the treatment of intraabdominal high testis. Wang, CY., Wang, Y., Chen, XH., et al.[2018]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31784377/

Revisiting the success rate of one-stage Fowler-Stephens ...

Methods: We retrospectively reviewed the charts of 43 boys who underwent one-stage FSO for 45 testes from 2003 to 2018 by a single surgeon at our institution.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S147751312300075X

Compared outcomes of high-level cryptorchidism managed ...

The Shehata technique demonstrated better performance than staged FSO regarding the overall success and atrophy rate, while the retraction rate and operation ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39079708/

Comparative Outcomes of Single-Stage versus Two ...

Two-stage LFSO remains the first choice of operation for children with a high IAT, with a significantly higher success rate and a lower testicular atrophy rate.

4.

withpower.com

withpower.com/trial/phase-cryptorchidism-7-2014-84684

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 ...

5.

ovid.com

ovid.com/journals/eujps/fulltext/10.1055/a-2375-9784~comparative-outcomes-of-single-stage-versus-two-stage

Comparative Outcomes of Single-Stage versus...

Two-stage LFSO remains the first choice of operation for children with a high IAT, with a significantly higher success rate and a lower testicular atrophy rate.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02235623

Study Details | NCT02235623 | Orchidopexy Randomized ...

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 ...

7.

jpurol.com

jpurol.com/article/S1477-5131(20)30004-8/pdf

How far can one-stage laparoscopic Fowler-Stephens ...

The aim of the study was to compare the outcome of the prospective cohort who had one-stage laparo- scopic Fowler-Stephens orchiopexy (LFSO) ...