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

Primary Purpose

Prostate Cancer, Quality of Life, Orchiectomy

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Bilateral simple orchidectomy (BSO)
Bilateral Subcapsular Orchidectomy
Bilateral Epididymal-sparing Orchidectomy
Sponsored by
University College Hospital, Ibadan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer focused on measuring orchidectomy, pseudotesticle

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • University College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Bilateral simple orchidectomy (BSO)

Subcapsular orchidectomy (BSCO)

Epididymal-sparing orchidectomy (BESO)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Serum PSA levels
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
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).

Full Information

First Posted
July 30, 2018
Last Updated
May 8, 2023
Sponsor
University College Hospital, Ibadan
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1. Study Identification

Unique Protocol Identification Number
NCT03744494
Brief Title
Cosmetic Appeal, HRQoL and Effectiveness of Simple and Pseudotesticular Techniques of Orchidectomy in Prostate Cancer
Acronym
TEPSO
Official Title
Comparison of the Therapeutic Efficacy and Patient Satisfaction of Three Techniques of Bilateral Orchidectomy in Prostate Cancer Patients of a Nigerian Sub-population (TEPSO)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2016 (Actual)
Primary Completion Date
February 26, 2018 (Actual)
Study Completion Date
February 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Hospital, Ibadan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Quality of Life, Orchiectomy
Keywords
orchidectomy, pseudotesticle

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three groups of patients subjected to a type of orchidectomy each
Masking
Participant
Masking Description
The patient, unaware of which surgery was done, would grade the scrotal appearance three months afterwards
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral simple orchidectomy (BSO)
Arm Type
Experimental
Arm Description
The patients would have the testis, epididymis and distal cord structures excised
Arm Title
Subcapsular orchidectomy (BSCO)
Arm Type
Experimental
Arm 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
Arm Title
Epididymal-sparing orchidectomy (BESO)
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Bilateral simple orchidectomy (BSO)
Intervention Type
Procedure
Intervention Name(s)
Bilateral Subcapsular Orchidectomy
Intervention Type
Procedure
Intervention Name(s)
Bilateral Epididymal-sparing Orchidectomy
Primary Outcome Measure Information:
Title
Summative and domain quality of life scores
Description
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.
Time Frame
Three months
Title
Summative and domain quality of life scores
Description
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.
Time Frame
Three months
Title
Change in pseudotesticular volume
Description
A Prader orchidometer was used to measure the pre-operative testicular volume and post-operative pseudotesticular volume in cm3
Time Frame
Three months
Title
Satisfaction with scrotal appearance
Description
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
Time Frame
three months after the orchidectomy
Secondary Outcome Measure Information:
Title
Serum PSA levels
Description
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.
Time Frame
Three months (timed interval sampling)
Title
Serum testosterone levels
Description
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).
Time Frame
Three months (timed interval sampling)
Other Pre-specified Outcome Measures:
Title
Socioeconomic standing of the patients
Description
The EPIC 2.2002 questionnaire was used to determine the relationship, occupational, educational and financial statuses of the patients
Time Frame
Snap-shot assessment at enrolment

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males with advanced prostate cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ijeoma NC Chibuzo, MBBS, MSc
Organizational Affiliation
University College Hospital, Ibadan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Hospital
City
Ibadan
State/Province
Oyo
ZIP/Postal Code
200212
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Chibuzo INC, Takure AO, Shittu OB, Okeke LI,
Results Reference
result
PubMed Identifier
34868687
Citation
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.
Results Reference
derived
Links:
URL
https://www.hindawi.com/journals/pc/2021/9968570/
Description
Article publication on simple and pseudotesticular techniques of orchidectomy

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

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