Cosmetic Appeal, HRQoL and Effectiveness of Simple and Pseudotesticular Techniques of Orchidectomy in Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer; Quality of Life; Orchiectomy
• Interventions: Procedure: Bilateral Epididymal-sparing Orchidectomy; Procedure: Bilateral simple orchidectomy (BSO); Procedure: Bilateral Subcapsular Orchidectomy

• Registration Number: NCT03744494
• Lead Sponsor: University College Hospital, Ibadan

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.

Study Timeline

• Study Start: 2016-03-02
• Primary Completion: 2018-02-26
• Study Completion: 2018-02-26
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-16
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epididymal-sparing orchidectomy (BESO)	Bilateral Epididymal-sparing Orchidectomy	The epididymal sinus was developed. The epididymal vessels were sequentially clamped and divided, removing the testicle from the epididymis. The caput was looped to meet the head and the adjoining surfaces of the body sutured together (epididymoplasty) Vasectomy done to reduce future risk of epididymitis
Bilateral simple orchidectomy (BSO)	Bilateral simple orchidectomy (BSO)	The patients would have the testis, epididymis and distal cord structures excised
Subcapsular orchidectomy (BSCO)	Bilateral Subcapsular Orchidectomy	The tunica albuginea was incised longitudinally and the testicular parenchyma scraped off it. The hilar region was secured with a haemostat and the parenchyma excised off it. A haemostatic suture was applied at the hilum. A running interlocking water-tight capsular suture was inserted

Primary Outcome Measures

Name	Time	Method
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
Summative and domain quality of life scores	Three months	Life Satisfaction -8 questionnaire was used to complement the EPIC-26 in the QoLassessment pre-and post-operatively.; Lisat-8 is ranked from 1 to 6, with 5 and 6 denoting satisfaction (5: Satisfying; 6: Satisfying) while scores of 4 and below connote varied degrees of dissatisfaction (1: very dissatisfying; 2: Dissatisfying; 3: Rather dissatisfying; 4: Rather satisfying); 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

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

University College Hospital; 🇳🇬 Ibadan, Oyo, Nigeria