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

Loma Linda University (LLU)

Status

Enrolling

Conditions

Testicular Cancer

Treatments

Procedure: Radical external oblique fascia sparing orchiectomy

Procedure: Radical inguinal orchiectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06828185

5250002

Details and patient eligibility

About

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:

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

Full description

Radical inguinal orchiectomy is the standard of care surgical approach for removing a testicle when clinically there is concern for testicular cancer. The procedure is generally minor and performed in the outpatient setting. Recent data demonstrates a trend towards high opioid prescription following this procedure in an attempt to minimize postoperative pain, which is associated with persistent new opioid use in the future. Numerous efforts have been put in place to minimize postoperative pain following scrotal procedures, with success noted when opioid sparing pathways have been adopted. However, there has been sparse data on modifications within surgical technique that could improve patient pain following this procedure.

There have been various descriptions of technique to performing a radical orchiectomy which involves removal of the diseased testicle and spermatic cord. Classically, performing a radical inguinal orchiectomy involves incision of the external oblique fascia to expose and ligate the spermatic cord. During this step, the ilioinguinal nerve is exposed and can be injured by either traction injury or inadvertent transection. Modifications to this technique have been described which involve sparing of the external oblique fascia. Both approaches are performed via a similar incision and both the testicle and spermatic cord are removed. In fascia sparing modification, the spermatic cord is controlled, dissected, and subsequently ligated at the level of the superficial inguinal ring without incising the external oblique fascia. Proponents of this approach suggest the potential for less convalescence and faster recovery due to less tissue manipulation and avoidance of disturbances to the ilioinguinal nerve. Despite this potential benefit, there is no evidence to demonstrate superiority of either approach as it relates to patient recovery.

Therefore, we propose a randomized single-blinded clinical trial investigating postoperative pain outcomes of inguinal radical orchiectomy compared to external oblique fascia sparing radical orchiectomy.

Enrollment

80 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)