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

NCT03744494 | Completed

• 1 other identifier: 15/0424
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Quality of Life; Orchiectomy

Keywords

orchidectomy; pseudotesticle

Outcome Measures

Primary Outcomes (4)

• Summative and domain quality of life scores

  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.

  Three months

• Summative and domain quality of life scores

  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.

  Three months

• Change in pseudotesticular volume

  A Prader orchidometer was used to measure the pre-operative testicular volume and post-operative pseudotesticular volume in cm3

  Three months

• Satisfaction with scrotal appearance

  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

  three months after the orchidectomy

Secondary Outcomes (2)

• Serum PSA levels

  Three months (timed interval sampling)

• Serum testosterone levels

  Three months (timed interval sampling)

Other Outcomes (1)

• Socioeconomic standing of the patients

  Snap-shot assessment at enrolment

Study Arms (3)

Bilateral simple orchidectomy (BSO)

EXPERIMENTAL

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

Procedure: Bilateral simple orchidectomy (BSO)

Subcapsular orchidectomy (BSCO)

EXPERIMENTAL

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

Procedure: Bilateral Subcapsular Orchidectomy

Epididymal-sparing orchidectomy (BESO)

EXPERIMENTAL

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

Procedure: Bilateral Epididymal-sparing Orchidectomy

Interventions

Bilateral simple orchidectomy (BSO) PROCEDURE

Bilateral simple orchidectomy (BSO)

Bilateral Subcapsular Orchidectomy PROCEDURE

Subcapsular orchidectomy (BSCO)

Bilateral Epididymal-sparing Orchidectomy PROCEDURE

Epididymal-sparing orchidectomy (BESO)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Males with advanced prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive consenting patients with histologically confirmed locally advanced or metastatic PCa who have accepted to have an orchidectomy

You may not qualify if:

• Patients who have had bilateral orchidectomy
• Those who opt for medical castration

Sponsors & Collaborators

• University College Hospital, Ibadan: lead

Study Sites (1)

University College Hospital

Ibadan, Oyo State, 200212, Nigeria

Location

Related Publications (2)

• Chibuzo INC, Takure AO, Shittu OB, Okeke LI,

  RESULT

• Chibuzo INC, Takure AO, Shittu OB, Okeke LI. Cosmetic Appeal, HRQoL, and Effectiveness of Simple and Pseudotesticular Techniques of Orchidectomy in Prostate Cancer. Prostate Cancer. 2021 Nov 26;2021:9968570. doi: 10.1155/2021/9968570. eCollection 2021.

  PMID: 34868687 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ijeoma NC Chibuzo, MBBS, MSc

  University College Hospital, Ibadan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient, unaware of which surgery was done, would grade the scrotal appearance three months afterwards
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three groups of patients subjected to a type of orchidectomy each

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: November 16, 2018
• Study Start: March 2, 2016
• Primary Completion: February 26, 2018
• Study Completion: February 26, 2018
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)