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

NCT ID: NCT03744494

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-02

Study Completion Date

2018-02-26

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Quality of Life Orchiectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups of patients subjected to a type of orchidectomy each
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
The patient, unaware of which surgery was done, would grade the scrotal appearance three months afterwards

Study Groups

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Bilateral simple orchidectomy (BSO)

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

Group Type EXPERIMENTAL

Bilateral simple orchidectomy (BSO)

Intervention Type PROCEDURE

Subcapsular orchidectomy (BSCO)

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

Group Type EXPERIMENTAL

Bilateral Subcapsular Orchidectomy

Intervention Type PROCEDURE

Epididymal-sparing orchidectomy (BESO)

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

Group Type EXPERIMENTAL

Bilateral Epididymal-sparing Orchidectomy

Intervention Type PROCEDURE

Interventions

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Bilateral simple orchidectomy (BSO)

Intervention Type PROCEDURE

Bilateral Subcapsular Orchidectomy

Intervention Type PROCEDURE

Bilateral Epididymal-sparing Orchidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University College Hospital, Ibadan

OTHER

Sponsor Role lead

Responsible Party

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I.N. Chibuzo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ijeoma NC Chibuzo, MBBS, MSc

Role: PRINCIPAL_INVESTIGATOR

University College Hospital, Ibadan

Locations

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University College Hospital

Ibadan, Oyo State, Nigeria

Site Status

Countries

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Nigeria

References

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

Reference Type 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.

Reference Type DERIVED
PMID: 34868687 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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15/0424

Identifier Type: -

Identifier Source: org_study_id

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