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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2016/06/006986 |
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Date of registration:
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02-06-2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparing two techniques of surgical treatment for advanced prostate cancer
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Scientific title:
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In metastatic prostate cancer requiring bilateral orchidectomy, is the satisfaction and genital perception following subcapsular approach superior to extracapsular approach? |
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Date of first enrolment:
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27-01-2016 |
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Target sample size:
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70 |
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Recruitment status: |
Open to Recruitment |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=14087 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group Trial
Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
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Phase:
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N/A
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Countries of recruitment
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Bangladesh
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India
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Nepal
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Contacts
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Name:
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Chandrasingh J
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Address:
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Office of Department of Urology
Christian Medical College, Hospital, Vellore
632004
Vellore, TAMIL NADU
India |
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Telephone:
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04162282055 |
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Email:
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chandrasingh@cmcvellore.ac.in |
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Affiliation:
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Christian Medical College, Vellore, Tamilnadu |
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Name:
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Chandrasingh J
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Address:
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Office of Department of Urology
Christian Medical College, Hospital, Vellore
632004
Vellore, TAMIL NADU
India |
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Telephone:
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04162282055 |
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Email:
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chandrasingh@cmcvellore.ac.in |
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Affiliation:
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Christian Medical College, Vellore, Tamilnadu |
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients with newly diagnosed metastatic prostate cancer willing for surgical castration i.e orchiectomy, with or without Channel TURP
Exclusion criteria: Patients with Bleeding disorder or Uncorrected coagulopathy, and Psychiatric problems
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Metastatic Prostate Cancer
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Intervention(s)
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Intervention1: Bilateral Subcapsular Orchiectomy: Surgical procedure that removes of only the hormone producing component of both the testes and leaves behind their outer coverings which is capsule.
Control Intervention1: Bilateral Extracapsular Orchiectomy: Surgical procedure that involves complete removal of all components of both testes.
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Primary Outcome(s)
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To compare the genital perception of testicular loss and patientsâ?? satisfaction for Bilateral Subcapsular Orchiectomy (BSO) and Bilateral Extracapsular Orchiectomy (BEO) in the treatment of matastatic prostate cancerTimepoint: Before the operation and at three months after the operation
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Secondary Outcome(s)
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To compare Bilateral Subcapsular Orchiectomy (BSO) and Bilateral Extracapsular Orchiectomy (BEO) in terms of Operative time, complications.Timepoint: Complications assessment at one to two weeks after the operation
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Source(s) of Monetary Support
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Institutional Internal Fluid Research Funding, Christian Medical College, Hospital, Vellore
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Ethics review
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Status: Approved
Approval date: 27/07/2015
Contact:
Institutional Review Board (Silver, Research & Ethics Committee), CMC Vellore
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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