Orchiectomy Techniques for Testicular Cancer

(PRESERVE Trial)

Overseen By Brian Hu, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Loma Linda University

Must not be taking: Opiates

Disqualifiers: Clinical T4 disease, Substance abuse, Chemotherapy, others

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

Compensation: Varies

Number of Visits: 1

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical techniques for removing a testicle due to suspected cancer. The researchers aim to determine if one technique results in less pain, reduced need for painkillers, and fewer complications post-surgery. Eligible participants have been diagnosed with testicular cancer, are scheduled for surgery, and are not currently using opioids for other pain issues. The trial will specifically examine differences in pain and recovery between sparing the external oblique fascia muscle layer and not sparing it during surgery. As an unphased trial, this study allows patients to contribute to important research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used opioids within one month of joining the study.

What prior data suggests that these orchiectomy techniques are safe?

Research has shown that radical inguinal orchiectomy is a well-established and standard surgery for treating testicular cancer. It has been used for many years and is recognized for its safety. Patients undergoing this surgery generally experience a high survival rate, and it is considered the best method for removing cancerous testicles.

The radical external oblique fascia sparing orchiectomy is a newer technique that aims to reduce surgical trauma by preserving a layer of muscle tissue called the external oblique fascia. Some studies suggest that this method might lessen pain and speed up recovery. However, it is not as widely studied or used as the traditional surgery.

Both surgeries are considered safe, but the newer method may offer some benefits in terms of recovery. Although there is limited information on the long-term results of the fascia-sparing technique, early findings are promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two surgical techniques for testicular cancer, aiming to refine and improve treatment outcomes. Unlike the standard radical inguinal orchiectomy, which involves removing the testicle through the groin, the radical external oblique fascia sparing orchiectomy preserves more surrounding tissue, potentially reducing recovery time and complications. By exploring these two methods, the trial seeks to determine which approach offers better patient outcomes with fewer side effects, advancing surgical care for testicular cancer patients.

What evidence suggests that these orchiectomy techniques are effective for testicular cancer?

In this trial, participants will undergo one of two surgical techniques for treating testicular cancer. Research has shown that removing a testicle through surgery, known as radical inguinal orchiectomy, is highly effective for treating testicular cancer. Patients with germ cell tumors have a survival rate of over 95% five years after the procedure. This surgery is a common choice because it successfully removes cancer and offers high survival rates. The trial also studies a newer surgery called radical external oblique fascia sparing orchiectomy. This technique aims to reduce surgical trauma by preserving a part of the muscle called the external oblique fascia. Early studies suggest this method may cause less pain after surgery and allow for quicker recovery compared to traditional methods. Both surgeries effectively treat testicular cancer, but they focus on different aspects of recovery and patient comfort. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for men with suspected nonseminomatous or any type of testicular cancer who are candidates for radical orchiectomy. Specific eligibility criteria details were not provided, so interested individuals should inquire further to determine if they qualify.

Inclusion Criteria

Participants not currently using opiates for another reason

I have a testicular tumor and surgery to remove a testicle is planned.

I can take standard medications before and after surgery.

Exclusion Criteria

History of illicit substance abuse (including prior opioid abuse) except for marijuana

Opioid use within 1 month of study enrollment

I need surgery for a large testis mass that requires an incision bigger than 8 cm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either radical inguinal orchiectomy or external oblique fascia sparing orchiectomy

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative pain, neuropathic pain, and opioid consumption

1 week

Daily self-reports

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Radical external oblique fascia sparing orchiectomy
• Radical inguinal orchiectomy

Trial Overview The study compares two surgical methods: the traditional inguinal orchiectomy and a technique that spares the external oblique fascia. It's randomized and single-blinded, focusing on patient-reported outcomes like postoperative pain, narcotic use, neuropathic pain, and complications.

How Is the Trial Designed?

Group I: Radical inguinal orchiectomy Active Control 1 Intervention

Group II: Radical external oblique fascia sparing orchiectomy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Citations

1. auanews.net auanews.net/issues/articles/2025/february-2025/fascial-sparing-radical-orchiectomy-a-modern-approach-to-improving-convalescence

Fascial-Sparing Radical Orchiectomy: A Modern Approach ... Fascial-sparing orchiectomy offers a promising alternative for reducing pain and optimizing care in patients undergoing radical orchiectomy.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK562336/

Radical Orchiectomy and Testis-Sparing Surgery for Testicular ... Histological reports indicate that about two-thirds of patients with solid testicular masses ≤2.5 cm and negative serum tumor markers have benign lesions.[8] ...

3. withpower.com withpower.com/trial/orchiectomy-techniques-for-testicular-cancer-ee40c

Orchiectomy Techniques for Testicular Cancer The Radical external oblique fascia sparing orchiectomy is unique because it aims to preserve the external oblique fascia, potentially reducing surgical trauma ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/575563

Patient Reported Experiences With Sparing External ... The purpose of this study is to evaluate the difference in patient-reported postoperative outcomes between two standard-of-care surgical ...

5. tau.amegroups.org tau.amegroups.org/article/view/44902/html

Partial orchiectomy vs. radical orchiectomy for pediatric testis ... No patients developed distant metastasis, and survival was 100%, however 1 patient had local recurrence at 39 months and underwent radical orchiectomy. Patients ...

6. hopkinsmedicine.org hopkinsmedicine.org/health/conditions-and-diseases/testicular-cancer/partial-orchiectomy

Partial Orchiectomy While some evidence indicates that this can be done safely in some patients, it is not a proven or well-established technique. Before undergoing testis-sparing ...