Recruiting

Sparing External Oblique Fascia vs. Standard Inguinal Orchiectomy

Sponsor:

Loma Linda University

Code:

NCT06828185

Conditions

Testicular Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radical inguinal orchiectomy

Radical external oblique fascia sparing orchiectomy

Study Details

Brief 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. The main questions it aims to answer are:

1. Does sparing the external oblique fascia during orchiectomy reduce pain after surgery?
2. Is there a difference in narcotic consumption after surgery?
3. Is there a difference in neuropathic pain after surgery?
4. Is there a difference in complications after surgery?

Conditions

Testicular Cancer

Study ID

NCT06828185

Start date

Dec, 2026

Status verified date

Jul, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Radical inguinal orchiectomy

active comparator: Radical external oblique fascia sparing orchiectomy

Interventions

Radical inguinal orchiectomy

External oblique fascia will be incised during orchiectomy

Radical external oblique fascia sparing orchiectomy

External oblique fascia will be spared during orchiectomy

Primary outcome measure

  • Postoperative Pain Level [ Time Frame: Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7 ]

Central Contacts and Locations

Central contacts

Locations

Loma Linda University

Recruiting

Loma Linda, California, United States, 92354

Contacts

Muhannad Alsyouf, MD

909-558-4000Malsyouf@llu.edu

Principal Investigator:

Muhannad Alsyouf, MD

More Information

Sponsor

Loma Linda University

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • orchiectomy
  • postoperative pain
  • testis cancer
  • germ cell tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-07-10.