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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Radical inguinal orchiectomy
Procedure/SurgeryExternal oblique fascia will be incised during orchiectomy
Radical external oblique fascia sparing orchiectomy
Procedure/SurgeryExternal oblique fascia will be spared during orchiectomy
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Sponsors and contacts
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