Testicular CancerPRESERVENCT06828185
Patient Reported Experiences With Sparing External Oblique Fascia Vs Standard Inguinal Orchiectomy
A study testing Radical inguinal orchiectomy and Radical external oblique fascia sparing orchiectomy in people with Testicular Cancer, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the difference in patient-reported postoperative outcomes between two standard-of-care surgical techniques for radical orchiectomy (inguinal orchiectomy versus external oblique fascia sparing orchiectomy) for treatment of patients with suspected testicular malignancy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Radical inguinal orchiectomy and Radical external oblique fascia sparing orchiectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants undergoing radical orchiectomy for suspected testicular malignancy
- Testicular malignancy can be germ cell tumor or non germ cell tumors, including paratesticular tumors as long as a radical orchiectomy is planned
- Participants over 18 years of age who can provide informed consent
- Participants not currently using opiates for another reason
- Regional and metastatic patients are allowed, as long as participant does not require opiates for pain related to metastatic disease
- No contraindication for participant to receive standardized medication pathway in the peri-operative period.
Who cannot join
- Clinical T4 disease
- History of illicit substance abuse (including prior opioid abuse) except for marijuana
- Participants who underwent chemotherapy or radiotherapy prior to orchiectomy
- Opioid use within 1 month of study enrollment
- Participants with large testis masses requiring skin incision larger than 8 cm in size.
- Participants with large testis masses requiring orchiectomy through an incision other than the standard transverse inguinal incision (i.e. hockey stick incision, vertical incision)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University
Loma Linda, California, 92354
Muhannad Alsyouf, MD, 909-558-4000 ext. 44196, Malsyouf@llu.edu
Muhannad Alsyouf, MD
About this study
Official title: Patient Reported Experiences With Sparing ExteRnal Oblique Fascia Vs Standard Inguinal OrchiEctomy
The purpose of this study is to evaluate the difference in patient-reported postoperative outcomes between two standard-of-care surgical techniques for radical orchiectomy (inguinal orchiectomy versus external oblique fascia sparing orchiectomy) for treatment of patients with suspected testicular malignancy. The main questions it aims to answer are:
- Does sparing the external oblique fascia during orchiectomy reduce pain after surgery?
- Is there a difference in narcotic consumption after surgery?
- Is there a difference in neuropathic pain after surgery?
- Is there a difference in complications after surgery?
Read the detailed description
Radical inguinal orchiectomy is the standard of care surgical approach for removing a testicle when clinically there is concern for testicular cancer. The procedure is generally minor and performed in the outpatient setting. Recent data demonstrates a trend towards high opioid prescription following this procedure in an attempt to minimize postoperative pain, which is associated with persistent new opioid use in the future. Numerous efforts have been put in place to minimize postoperative pain following scrotal procedures, with success noted when opioid sparing pathways have been adopted. However, there has been sparse data on modifications within surgical technique that could improve patient pain following this procedure.
There have been various descriptions of technique to performing a radical orchiectomy which involves removal of the diseased testicle and spermatic cord. Classically, performing a radical inguinal orchiectomy involves incision of the external oblique fascia to expose and ligate the spermatic cord. During this step, the ilioinguinal nerve is exposed and can be injured by either traction injury or inadvertent transection. Modifications to this technique have been described which involve sparing of the external oblique fascia. Both approaches are performed via a similar incision and both the testicle and spermatic cord are removed. In fascia sparing modification, the spermatic cord is controlled, dissected, and subsequently ligated at the level of the superficial inguinal ring without incising the external oblique fascia. Proponents of this approach suggest the potential for less convalescence and faster recovery due to less tissue manipulation and avoidance of disturbances to the ilioinguinal nerve. Despite this potential benefit, there is no evidence to demonstrate superiority of either approach as it relates to patient recovery.
Therefore, we propose a randomized single-blinded clinical trial investigating postoperative pain outcomes of inguinal radical orchiectomy compared to external oblique fascia sparing radical orchiectomy.
- Conditions
- Testicular Cancer
- Being tested
- Radical inguinal orchiectomy, Radical external oblique fascia sparing orchiectomy
- Keywords
- orchiectomy, postoperative pain, testis cancer, germ cell tumors
- Medical subject headings
- Testicular Neoplasms, Pain, Postoperative, Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical inguinal orchiectomyProcedure or surgery
External oblique fascia will be incised during orchiectomy
Radical external oblique fascia sparing orchiectomyProcedure or surgery
External oblique fascia will be spared during orchiectomy
| Study group | Role | What they receive |
|---|---|---|
| Radical inguinal orchiectomy | Active comparator | Not described Receives: Procedure: Radical inguinal orchiectomy |
| Radical external oblique fascia sparing orchiectomy | Active comparator | Not described Receives: Procedure: Radical external oblique fascia sparing orchiectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Level
Post-operative pain levels will be measured by the Short Form Inguinal Pain Score (sf-IPQ) The score range is between 0 and 12, with zero points indicating no pain and 12 points indicating the most intense pain. Scores for subjects undergoing inguinal orchiectomy will be compared to subjects undergoing external oblique fascia sparing radical orchiectomy.
Measured: Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7
Secondary outcomes (2)
Opioid consumption
Subjects will self-report the total number of Oxycodone 5 mg tablets consumed for breakthrough pain during the first post-op week. There is no pre-defined range for this self-report but the higher the number of tablets consumed may be an indication of great pain intensity.
Measured: Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7
Neuropathic Pain Level
Post-Operative Neuropathic pain levels will be measured by the modified Barrow Neurological Institute hypesthesia scale. A total score ranging between 1 and 4, with 1 representing minimal neuropathic pain and 4 representing intense neuropathic pain.
Measured: Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study startDec 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828185
- Sponsor's protocol ID
- 5250002
- Acronym
- PRESERVE
- Status last verified
- Jul 2026
- First submitted
- 10 Feb 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shei A, Rice JB, Kirson NY, Bodnar K, Birnbaum HG, Holly P, Ben-Joseph R. Sources of prescription opioids among diagnosed opioid abusers. Curr Med Res Opin. 2015 Apr;31(4):779-84. doi: 10.1185/03007995.2015.1016607. Epub 2015 Feb 24.
PubMed 25661018
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Experiences With Sparing ExteRnal Oblique Fascia Vs Standard Inguinal OrchiEctomy
- ClinicalTrials.gov ID
- NCT06828185
- Acronym / sponsor ID
- PRESERVE / 5250002
- Conditions
- Testicular Cancer
- Keywords
- orchiectomy, postoperative pain, testis cancer, germ cell tumors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the difference in patient-reported postoperative outcomes between two standard-of-care surgical techniques for radical orchiectomy (inguinal orchiectomy versus external oblique fascia sparing orchiectomy) for treatment of patients with suspected testicular malignancy. The main questions it aims to answer are:
- Does sparing the external oblique fascia during orchiectomy reduce pain after surgery?
- Is there a difference in narcotic consumption after surgery?
- Is there a difference in neuropathic pain after surgery?
- Is there a difference in complications after surgery?
Detailed description
Radical inguinal orchiectomy is the standard of care surgical approach for removing a testicle when clinically there is concern for testicular cancer. The procedure is generally minor and performed in the outpatient setting. Recent data demonstrates a trend towards high opioid prescription following this procedure in an attempt to minimize postoperative pain, which is associated with persistent new opioid use in the future. Numerous efforts have been put in place to minimize postoperative pain following scrotal procedures, with success noted when opioid sparing pathways have been adopted. However, there has been sparse data on modifications within surgical technique that could improve patient pain following this procedure.
There have been various descriptions of technique to performing a radical orchiectomy which involves removal of the diseased testicle and spermatic cord. Classically, performing a radical inguinal orchiectomy involves incision of the external oblique fascia to expose and ligate the spermatic cord. During this step, the ilioinguinal nerve is exposed and can be injured by either traction injury or inadvertent transection. Modifications to this technique have been described which involve sparing of the external oblique fascia. Both approaches are performed via a similar incision and both the testicle and spermatic cord are removed. In fascia sparing modification, the spermatic cord is controlled, dissected, and subsequently ligated at the level of the superficial inguinal ring without incising the external oblique fascia. Proponents of this approach suggest the potential for less convalescence and faster recovery due to less tissue manipulation and avoidance of disturbances to the ilioinguinal nerve. Despite this potential benefit, there is no evidence to demonstrate superiority of either approach as it relates to patient recovery.
Therefore, we propose a randomized single-blinded clinical trial investigating postoperative pain outcomes of inguinal radical orchiectomy compared to external oblique fascia sparing radical orchiectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical inguinal orchiectomy | Active comparator | Procedure: Radical inguinal orchiectomy |
| Radical external oblique fascia sparing orchiectomy | Active comparator | Procedure: Radical external oblique fascia sparing orchiectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants undergoing radical orchiectomy for suspected testicular malignancy
- Testicular malignancy can be germ cell tumor or non germ cell tumors, including paratesticular tumors as long as a radical orchiectomy is planned
- Participants over 18 years of age who can provide informed consent
- Participants not currently using opiates for another reason
- Regional and metastatic patients are allowed, as long as participant does not require opiates for pain related to metastatic disease
Key exclusion criteria (6 listed)
- Clinical T4 disease
- History of illicit substance abuse (including prior opioid abuse) except for marijuana
- Participants who underwent chemotherapy or radiotherapy prior to orchiectomy
- Opioid use within 1 month of study enrollment
- Participants with large testis masses requiring skin incision larger than 8 cm in size.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical inguinal orchiectomyExternal oblique fascia will be incised during orchiectomy | Procedure or surgery | Radical inguinal orchiectomy |
| Radical external oblique fascia sparing orchiectomyExternal oblique fascia will be spared during orchiectomy | Procedure or surgery | Radical external oblique fascia sparing orchiectomy |
Primary outcome
Postoperative Pain Level
Time frame: Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7
Post-operative pain levels will be measured by the Short Form Inguinal Pain Score (sf-IPQ) The score range is between 0 and 12, with zero points indicating no pain and 12 points indicating the most intense pain. Scores for subjects undergoing inguinal orchiectomy will be compared to subjects undergoing external oblique fascia sparing radical orchiectomy.
2 secondary outcomes
Opioid consumption
Time frame: Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7
Neuropathic Pain Level
Time frame: Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 25661018Shei A, Rice JB, Kirson NY, Bodnar K, Birnbaum HG, Holly P, Ben-Joseph R. Sources of prescription opioids among diagnosed opioid abusers. Curr Med Res Opin. 2015 Apr;31(4):779-84. doi: 10.1185/03007995.2015.1016607. Epub 2015 Feb 24.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical inguinal orchiectomy and Radical external oblique fascia sparing orchiectomy in people with Testicular Cancer, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhannad Alsyouf, MD (9095584000 ext. 44196, Malsyouf@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Level (time frame: Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06828185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.