Comparison of the Therapeutic Efficacy and Patient Satisfaction of Three Techniques of Bilateral Orchidectomy in Prostate Cancer Patients of a Nigerian Sub-population (TEPSO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Change in pseudotesticular volume
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The patient, unaware of which surgery was done, would grade the scrotal appearance three months afterwards
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Consecutive consenting patients with histologically confirmed locally advanced or metastatic PCa who have accepted to have an orchidectomy
排除标准
- •Patients who have had bilateral orchidectomy
- •Those who opt for medical castration
结局指标
主要结局
Change in pseudotesticular volume
时间窗: 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
时间窗: 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
Summative and domain quality of life scores
时间窗: 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.
次要结局
- Serum PSA levels(Three months (timed interval sampling))
- Serum testosterone levels(Three months (timed interval sampling))
研究者
I.N. Chibuzo
Principal Investigator
University College Hospital, Ibadan