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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorLoma Linda University

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radical inguinal orchiectomy

    Procedure/Surgery

    External oblique fascia will be incised during orchiectomy

  • Radical external oblique fascia sparing orchiectomy

    Procedure/Surgery

    External oblique fascia will be spared during orchiectomy

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Radical inguinal orchiectomyActive comparator 1 intervention
Group B: Radical external oblique fascia sparing orchiectomyActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7
2

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.

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

Other outcomes

Sponsors and contacts

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