Patient Reported Experiences With Sparing External Oblique Fascia Vs Standard Inguinal Orchiectomy

NCT06828185 | Recruiting

• 1 other identifier: 5250002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Testicular Cancer

Keywords

orchiectomy; postoperative pain; testis cancer; germ cell tumors

Outcome Measures

Primary Outcomes (1)

• 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.

  Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7

Secondary Outcomes (2)

• Opioid consumption

  Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7

• Neuropathic Pain Level

  Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7)

Study Arms (2)

Radical inguinal orchiectomy

ACTIVE COMPARATOR

Procedure: Radical inguinal orchiectomy

Radical external oblique fascia sparing orchiectomy

ACTIVE COMPARATOR

Procedure: Radical external oblique fascia sparing orchiectomy

Interventions

Radical inguinal orchiectomy PROCEDURE

External oblique fascia will be incised during orchiectomy

Radical inguinal orchiectomy

Radical external oblique fascia sparing orchiectomy PROCEDURE

External oblique fascia will be spared during orchiectomy

Radical external oblique fascia sparing orchiectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 25661018 BACKGROUND

MeSH Terms

Conditions

Testicular Neoplasms; Pain, Postoperative; Neoplasms, Germ Cell and Embryonal

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplasms by Histologic Type

Central Study Contacts

Muhannad Alsyouf, MD

CONTACT

9095584000; Malsyouf@llu.edu

Brian Hu, MD

CONTACT

9095584000; Bhu@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)