Clinical trial · Interventional
Patient Reported Experiences With Sparing External Oblique Fascia Vs Standard Inguinal Orchiectomy
Patient Reported Experiences With Sparing ExteRnal Oblique Fascia Vs Standard Inguinal OrchiEctomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical external oblique fascia sparing orchiectomy | Procedure | — | UNRESOLVED |
| Radical inguinal orchiectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radical inguinal orchiectomy
- interventionNames
- Procedure: Radical inguinal orchiectomy
- type
- ACTIVE_COMPARATOR
- label
- Radical external oblique fascia sparing orchiectomy
- interventionNames
- Procedure: Radical external oblique fascia sparing orchiectomy
Primary outcomes (1)
- measure
- Postoperative Pain Level
- timeFrame
- Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- BACKGROUNDShei 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