Orchiectomy, Prostate Cancer, Quality of Life
Conditions
Keywords
orchidectomy, pseudotesticle
Brief summary
The therapeutic efficacy of three types of orchidectomy was ascertained as well as the QoL and scrotal cosmetic satisfaction of patients in the three surgical arms. Two of these surgeries produced a pseudotesticle (BSCO, BESO) while one (BSO) did not.
Detailed description
Patients with prostate cancer (PCa) were grouped into three surgical arms: BSO (bilateral simple orchidectomy), BSCO (bilateral subcapsular orchidectomy) and BESO (bilateral epididymal-sparing orchidectomy). Preoperatively, baseline serum testosterone, PSA, Quality of life (QoL) and pre-operative testicular volumes were obtained. Timed interval sampling for serum testosterone and PSA variation was done post-operatively. By three months post-op, the cosmetic appeal of the scrotal appearance, post-operative pseudotesticular volumes and QoL were also assessed. The therapeutic efficacy of the surgeries was determined by the rates of decline of serum testosterone and PSA, as well as the nadirs achieved. The variations in the pre-and post-operative QoL was analysed.
Interventions
PROCEDUREBilateral Subcapsular Orchidectomy
PROCEDUREBilateral Epididymal-sparing Orchidectomy
PROCEDUREBilateral simple orchidectomy (BSO)
Sponsors
University College Hospital, Ibadan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
The patient, unaware of which surgery was done, would grade the scrotal appearance three months afterwards
Intervention model description
Three groups of patients subjected to a type of orchidectomy each
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive consenting patients with histologically confirmed locally advanced or metastatic PCa who have accepted to have an orchidectomy
Exclusion criteria
* Patients who have had bilateral orchidectomy * Those who opt for medical castration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summative and domain quality of life scores | Three months | Expanded Prostate Cancer Index Composite- 26 questionnaires were also used to assess various aspects of the QoL pre-and post-operatively. EPIC 26 scores are ranked from 0 to 100 with higher scores indicating better function and less bother. Urinary incontinence, Lower Urinary Tract Symptoms, Bowel function/bother, Sexual function/bother, Hormone and vitality were assessed. |
| Change in pseudotesticular volume | Three months | A Prader orchidometer was used to measure the pre-operative testicular volume and post-operative pseudotesticular volume in cm3 |
| Satisfaction with scrotal appearance | three months after the orchidectomy | Patient rating of cosmetic appeal of the scrotum using a graduated Visual Analog Scale rated between 0 and 100 to signify a score of 0 to 100%. Higher values indicated better satisfaction with scrotal appearance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum PSA levels | Three months (timed interval sampling) | The serum PSA levels in ng/ml were measured pre-operatively, at removal of the testes, hourly for the first three hours, at seven days and three months post-operatively. Percentage PSA declines, PSA nadirs (ng/ml) and time to the attainment of PSA nadirs (hours) were determined from the data obtained. |
| Serum testosterone levels | Three months (timed interval sampling) | The serum testosterone levels in nmol/l were measured pre-operatively, at removal of the testes, hourly for the first three hours, at seven days and three months post-operatively. The attainment of surgical castrate levels of 20nmol/l or medical castrate levels of 20 nmol/l or medical castrate levels of 50nmol/l was assessed for as well as the testosterone nadirs achieved (nmol/l) and time to the attainment of testosterone nadirs (hours). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Socioeconomic standing of the patients | Snap-shot assessment at enrolment | The EPIC 2.2002 questionnaire was used to determine the relationship, occupational, educational and financial statuses of the patients |
Countries
Nigeria
Outcome results
None listed