Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone

Launched by EMORY UNIVERSITY · Jan 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of testosterone replacement therapy given around the time of major urologic surgery in men who have low testosterone levels. The goal is to see if this therapy can improve recovery after surgery, such as reducing hospital stays, complications, and the risk of death. Previous research suggests that testosterone therapy can help increase muscle mass, reduce fat, improve physical function, and strengthen bones, which might be beneficial for patients undergoing surgery.

To participate in this trial, you must be a male patient scheduled for major surgery that requires at least one night in the hospital. You should be able to give your consent for the study and be willing to complete some assessments before and after surgery. However, there are some exclusions, such as a history of certain cancers or treatments, current hormone therapies, and specific medical conditions. If you join the trial, you'll receive testosterone therapy around the time of your surgery, and researchers will monitor your recovery closely to gather important information about its safety and effectiveness.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Patients already scheduled for major surgery requiring an overnight hospital stay
• • Patients must be able to give informed consent
• • Patients must be willing to do study's preoperative and post-operative assessment tools
• Exclusion Criteria:
• • Patient with history of prostatectomy with detectable prostate specific antigen (PSA)
• • Patient with history of prostate radiation/chemotherapy treatment and has experienced bounce or rise in PSA
• • Patients with history of/undergoing orchiectomy
• • Patients undergoing hormone replacement therapy currently or history of testosterone use within last year
• • Patients who use anabolic steroids
• • Patients with history of solitary or undescended testis
• • Patients with history of pituitary disorders
• • Patients with history of thromboembolic events in last year
• • Patients with hematocrit \> 55%
• • Patients with uncontrolled congestive heart failure
• • Special populations: Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women and prisoners