Comparing two surgical techniques for testicular cancer treatment
Patient Reported Experiences With Sparing ExteRnal Oblique Fascia Vs Standard Inguinal OrchiEctomy
This study is testing if a new surgical method for treating testicular cancer can help patients feel less pain and need fewer pain medications after surgery compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Loma Linda University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT06828185 on ClinicalTrials.gov |
What this trial studies
This study evaluates the differences in patient-reported postoperative outcomes between two surgical techniques for radical orchiectomy in patients with suspected testicular cancer. It aims to determine if sparing the external oblique fascia during surgery reduces postoperative pain, narcotic consumption, neuropathic pain, and complications compared to the standard inguinal orchiectomy. The study involves participants undergoing the procedure in an outpatient setting and focuses on improving pain management and reducing opioid use post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old undergoing radical orchiectomy for suspected testicular malignancy.
Not a fit: Patients with clinical T4 disease or those with a history of illicit substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative pain management and reduced reliance on narcotics for patients undergoing orchiectomy.
How similar studies have performed: While there have been efforts to minimize postoperative pain in similar procedures, this specific approach of fascia sparing during orchiectomy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Loma Linda, California
- Loma Linda University — Loma Linda, California, United States (Recruiting)
Study contacts
- Study coordinator: Muhannad Alsyouf, MD
- Email: Malsyouf@llu.edu
- Phone: 9095584000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.