One-Stage vs Two-Stage Orchidopexy for Undescended Testicles

(GSLO Trial)

Overseen By Melissa McGrath

Age: < 18

Sex: Male

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Previous orchidopexy, Palpable testes, Orchiectomy

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3-6 months for two-stage procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which surgical method is better for boys with undescended testicles that can't be felt or are inside the abdomen. Researchers are comparing two techniques: the One-Stage GSLO Technique, which resolves the issue in a single surgery, and the Two-Stage GSLO Technique, which does so in two steps. The focus is on identifying which method more effectively prevents testicular atrophy (shrinkage). Boys diagnosed with intra-abdominal undescended testicles who require surgical repair are suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to important research that may improve surgical outcomes for future patients.

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

Research has shown that both the one-stage and two-stage gubernaculum-sparing laparoscopic orchidopexy (GSLO) techniques are generally well-tolerated. In the two-stage GSLO, studies have noted rare complications such as bladder and vessel injuries. Overall, these procedures are usually safe for most patients.

It is important to understand that these are surgical procedures, not drugs, and have been in use for some time. Doctors have experience with them, and while complications can occur, they are uncommon. Both techniques aim to lower the risk of testicular shrinkage and are standard treatments for undescended testicles in boys. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing one-stage versus two-stage GSLO techniques for undescended testicles because it could redefine surgical approaches for this condition. The one-stage GSLO technique offers a simpler, single-operation solution, potentially reducing the stress and recovery time associated with multiple surgeries. In contrast, the two-stage GSLO technique might provide better outcomes for higher-risk cases by carefully positioning the testicle over two procedures. By evaluating these approaches, researchers aim to find out which method provides the best balance of effectiveness and patient comfort, potentially improving the standard of care for children with undescended testicles.

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

This trial will compare the effectiveness of one-stage and two-stage gubernaculum-sparing laparoscopic orchidopexy (GSLO) for treating undescended testicles. Research has shown that both approaches are effective. Participants will be assigned to either the one-stage or two-stage GSLO technique. Some studies suggest that the two-stage approach might be more effective in certain cases, such as when the testicle is located inside the abdomen. However, other studies have found the one-stage method to be equally effective. The main difference is that the two-stage method involves two separate surgeries, which might be less stressful for the testicle. Both methods aim to reduce the risk of testicle shrinkage and improve the chances of successful placement. ^{2 4 5 6 7}

Who Is on the Research Team?

Luis H Braga, M.D.

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• One-Stage GSLO Technique
• Two-Stage GSLO Technique

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.

How Is the Trial Designed?

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 European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as One-Stage GSLO for:

• Undescended Testis (UDT)
• Cryptorchidism

Approved in United States as One-Stage GSLO for:

• Undescended Testis (UDT)
• Cryptorchidism

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+

McMaster Surgical Associates

Collaborator

Trials

17

Recruited

46,500+

Published Research Related to This Trial

A series of 14 patients (16 testes) underwent laparoscopic single-stage orchiopexy for undescended testis, with no reported cases of testicular loss or acute atrophy after 6 months of follow-up, indicating the safety of this minimally invasive procedure.

This study also highlights the successful completion of stage 2 orchiopexy using laparoscopic techniques, marking a significant advancement in the surgical treatment of impalpable undescended testis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic single stage and staged orchiopexy. Jordan, GH., Winslow, BH.[2019]

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]

In a study of 205 patients undergoing second-stage gubernaculum-sparing orchiopexy, both open and laparoscopic techniques showed very low rates of testicular atrophy (1.5% overall), indicating high testicular survival rates for both methods.

There were no significant differences in complications or testicular ascent rates between the open and laparoscopic approaches, suggesting that either technique is equally effective and safe for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Versus Laparoscopic Gubernaculum-Sparing Second-Stage Fowler-Stephens Orchiopexy for Intra-Abdominal Testis: A Long-Term Study. Zhou, G., Chen, J., Yin, J., et al.[2022]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6452555/

Gubernaculum Sparing Laparoscopic Orchiopexy in ... Robertson S. A., Munro F. D., MacKinlay G. A. Two-stage Fowler-Stephens orchidopexy preserving the gubernacular vessels and a purely laparoscopic second stage.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9258174/

Two-stage Fowler-Stephens orchiopexy with laparoscopic ... Purpose: We report the outcome of a staged approach to the intra-abdominal testicle and provide baseline data on operative time, postoperative course and ...

3. liebertpub.com liebertpub.com/doi/full/10.1089/lap.2021.0843

Open Versus Laparoscopic Gubernaculum-Sparing ... Studies show that the two-stage Fowler–Stephens orchiopexy (FSO) is better than the one-stage FSO, such that the two-stage technique is now the ...

4. researchgate.net researchgate.net/publication/6445414_Two-Stage_Fowler-Stephens_Orchidopexy_Preserving_The_Gubernacular_Vessels_And_A_Purely_Laparoscopic_Second_Stage

Two-Stage Fowler-Stephens Orchidopexy Preserving The ... Aim: To assess the outcome of gubernaculum sparing laparoscopic assisted FS orchidopexy technique for bilateral intra-abdominal testes.

5. journals.lww.com journals.lww.com/ejos/fulltext/2023/42040/surgical_and_morphological_outcome_of_one_stage.26.aspx

Surgical and morphological outcome of one-stage... One-stage laparoscopic FS orchidopexy with preservation of gubernaculum is as effective as two-stage laparoscopic FS orchidopexy with preservation of ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022346825005123

Two-stage Fowler-Stephens orchidopexy in management ... To assess outcomes of staged Fowler-Stephens orchidopexy (FSO) in management of intra-abdominal testes (IAT) in six paediatric tertiary centres in the UK.

7. jpedsurg.org jpedsurg.org/article/S0022-3468(25)00512-3/abstract

Two-Stage Fowler-Stephens orchidopexy in Management ... Other reported complications included bladder injury (2 patients), ureteric injury (1 patient), external iliac vein injury (1 patient), inadvertent orchidectomy ...