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

February 2, 2026 updated by: Loma Linda University

Patient Reported Experiences With Sparing ExteRnal Oblique Fascia Vs Standard Inguinal OrchiEctomy

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Muhannad Alsyouf, MD
  • Phone Number: 44196 9095584000
  • Email: Malsyouf@llu.edu

Study Contact Backup

  • Name: Brian Hu, MD
  • Phone Number: 44196 9095584000
  • Email: Bhu@llu.edu

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University
        • Contact:
        • Principal Investigator:
          • Muhannad Alsyouf, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radical inguinal orchiectomy
Procedure: Radical inguinal orchiectomy
External oblique fascia will be incised during orchiectomy
Active Comparator: Radical external oblique fascia sparing orchiectomy
Procedure: Radical external oblique fascia sparing orchiectomy
External oblique fascia will be spared during orchiectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Level
Time Frame: Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7
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.
Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7
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.
Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7
Neuropathic Pain Level
Time Frame: Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7)
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.
Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5250002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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