One-Stage vs Two-Stage Orchidopexy for Undescended Testicles

(GSLO Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Luis H Braga, M.D.

Age: < 18

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: McMaster University

Disqualifiers: Previous orchidopexy, Palpable testes, Orchiectomy

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares two surgical methods for moving undescended testicles in young boys. One method completes the surgery in a single procedure, while the other does it in multiple stages. The goal is to see which method better prevents testicle shrinkage.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment One-Stage vs Two-Stage Orchidopexy for Undescended Testicles?

Research shows that both one-stage and two-stage gubernaculum-sparing laparoscopic orchiopexy techniques have high testicular survival rates and satisfactory testicular positions, with no significant difference in complications or testicular ascent between the two methods. ^{1 2 3 4 5}

Is the one-stage or two-stage orchidopexy for undescended testicles safe?

Both one-stage and two-stage orchidopexy procedures for undescended testicles have been studied for safety, with low rates of complications such as testicular atrophy (shrinkage) and testicular ascent (movement). The overall testicular atrophy rate was found to be 1.5%, and there was no significant difference in complications between open and laparoscopic approaches. ^{1 2 3 5 6}

How does the One-Stage vs Two-Stage GSLO treatment for undescended testicles differ from other treatments?

The One-Stage and Two-Stage GSLO treatments for undescended testicles are unique because they use a minimally invasive laparoscopic technique that preserves the gubernaculum (a structure that helps guide the testicle into the scrotum), which may reduce the risk of testicular atrophy (shrinkage) and improve positioning. This approach contrasts with traditional methods that may involve more invasive surgery or do not focus on preserving the gubernaculum. ^{1 2 4 7 8}

Research Team

Luis H Braga, M.D.

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for boys aged 1-5 with undescended testicles located inside the abdomen, who haven't had previous laparoscopic surgery for this condition. The procedure will be done by specialized Pediatric Urologists.

Inclusion Criteria

I have been diagnosed with undescended testicles within my abdomen.

I am a boy between 1-5 years old seeing a pediatric urologist.

I need a specialized surgery for my condition, performed by a trained Pediatric Urologist.

Exclusion Criteria

I can feel my testicles when I touch them.

I need surgery to remove one or both of my testicles.

I have had surgery to correct an undescended testicle.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a one-stage or two-stage gubernaculum sparing laparoscopic orchidopexy (GSLO). The two-stage procedure involves an initial ligation of testicular vessels, followed by a second stage 3-6 months later for testis mobilization and fixation.

3-6 months for two-stage procedure

Follow-up

Participants are monitored for postoperative testicular atrophy and other outcomes.

12 months

Treatment Details

Interventions

• One-Stage GSLO Technique (Procedure)
• Two-Stage GSLO Technique (Procedure)

Trial Overview The study compares two surgical methods to correct undescended testicles: a one-stage and a two-stage technique using laparoscopy. It aims to determine which method better prevents testicular atrophy, or shrinkage of the testes.

Participant Groups

Group I: Intervention Group: Two-Stage GSLO Technique Experimental Treatment 1 Intervention

Gubernaculum-sparing laparoscopic orchidopexy will be done in two stages

Group II: Control Group: One-Stage GSLO Technique Experimental Treatment 1 Intervention

Gubernaculum-sparing laparoscopic orchidopexy will be done in a single stage

One-Stage GSLO Technique is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as One-Stage GSLO for:

• Undescended Testis (UDT)
• Cryptorchidism

Approved in Japan as One-Stage GSLO for:

• Undescended Testis (UDT)
• Cryptorchidism

Approved in China as One-Stage GSLO for:

• Undescended Testis (UDT)
• Cryptorchidism

Approved in Switzerland as One-Stage GSLO for:

• Undescended Testis (UDT)
• Cryptorchidism

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Evan Stein

McMaster University

Chief Medical Officer since 2015

MD, PhD

Sam

McMaster University

Chief Executive Officer since 2023

MBA from McMaster University

McMaster Surgical Associates

Collaborator

Trials

17

Recruited

46,500+

Findings from Research

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 study of 7 boys undergoing laparoscopic one-stage Fowler-Stephens orchiopexy for high intrapelvic testis, 71.4% of the testes were found to be normal in volume and scrotal location after an average follow-up of 14 months.

The technique's success is attributed to the preservation of the gubernaculum's collateral vasculature, which is crucial for testicular survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic one-stage Fowler-Stephens orchiopexy preserving gubernaculum. Naycı, A., Bahadır, GB., Erdoğan, C., et al.[2020]

The study reviewed 48 laparoscopic Fowler-Stephens orchiopexies for nonpalpable testes, finding an overall success rate of 91.1%, with a higher success rate of 94.3% for the single-stage procedure.

Both single-stage and two-stage procedures are effective, but the key to achieving a high success rate is minimizing manipulation of the vas deferens and epididymis during the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic Fowler-Stephens orchiopexy: the Westchester Medical Center experience. Chang, M., Franco, I.[2019]

The two-stage Fowler-Stephens orchiopexy is an effective surgical method for correcting high intra-abdominal testes, with only 0-13% of testicles found in an inappropriate position during follow-up periods of 6-37 months.

The rate of repeat orchiopexy after this procedure is relatively low, ranging from 2.6% to 7.5%, indicating that most patients do not require additional surgery after the initial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staged Fowler Stephens, Who Requires a Third Procedure? Hayes, M., Patel, A., Seideman, C.[2021]

Gubernaculum sparing laparoscopic orchiopexy significantly reduces the rate of testicular atrophy compared to conventional laparoscopic Fowler-Stephens orchiopexy, with atrophy rates of 0.6% versus 28.3%, respectively, based on a study of 212 cases.

This technique appears to enhance testicular survival by preserving additional blood supply, suggesting it is a safer and more effective option for surgical correction of undescended testes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gubernaculum Testis and Cremasteric Vessel Preservation during Laparoscopic Orchiopexy for Intra-Abdominal Testes: Effect on Testicular Atrophy Rates. Braga, LH., Farrokhyar, F., McGrath, M., et al.[2019]

In a study of 105 patients with impalpable testes, the single-stage orchidopexy approach was found to be safe and effective, with no cases of testicular atrophy or reascension during a mean follow-up of 17 months.

The two-stage orchidopexy, which involves ligation of testicular vessels, resulted in complications such as atrophy and infection, suggesting that this method should only be used for specific cases with high abdominal testes and short vessels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of laparoscopic orchidopexy in intra-abdominal testis]. Neissner, C., Ebert, AK., Rösch, WH.[2021]

References

1. United States 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. [2018]

2. Turkey pubmed.ncbi.nlm.nih.gov

Laparoscopic one-stage Fowler-Stephens orchiopexy preserving gubernaculum. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Open Versus Laparoscopic Gubernaculum-Sparing Second-Stage Fowler-Stephens Orchiopexy for Intra-Abdominal Testis: A Long-Term Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic Fowler-Stephens orchiopexy: the Westchester Medical Center experience. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Staged Fowler Stephens, Who Requires a Third Procedure? [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Gubernaculum Testis and Cremasteric Vessel Preservation during Laparoscopic Orchiopexy for Intra-Abdominal Testes: Effect on Testicular Atrophy Rates. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic single stage and staged orchiopexy. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Analysis of laparoscopic orchidopexy in intra-abdominal testis]. [2021]