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

University College Hospital, Ibadan

Status: Completed

Conditions: Orchiectomy; Quality of Life; Prostate Cancer

Treatments: Procedure: Bilateral Subcapsular Orchidectomy; Procedure: Bilateral simple orchidectomy (BSO); Procedure: Bilateral Epididymal-sparing Orchidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03744494

15/0424

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 3 patient groups

Bilateral simple orchidectomy (BSO)

Experimental group

Description:

The patients would have the testis, epididymis and distal cord structures excised

Treatment:

Procedure: Bilateral simple orchidectomy (BSO)

Subcapsular orchidectomy (BSCO)

Experimental group

Description:

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

Treatment:

Procedure: Bilateral Subcapsular Orchidectomy

Epididymal-sparing orchidectomy (BESO)

Experimental group

Description:

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

Treatment:

Procedure: Bilateral Epididymal-sparing Orchidectomy