Comparison of two methods Open Prostatectomy and classic TURP (Transurethral Resection of the Prostate) in patients suffering from benign prostatic hyperplasia
Design
Clinical trials with control group, randomized, with parallel groups
Settings and conduct
100 patients with benign prostatic hyperplasia referred to the Urology Clinic of Shahid Rahnemoon Hospital of Yazd are enrolled according to inclusion and exclusion criteria and then assigned to two intervention and control groups by using sealed envelopes previously prepared and containing the name of the intervention - open surgery or TURP – in equal proportions. After Cystoscopy in Intervention group by open surgery and in Control group by TURP method Prostatectomy is performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Classical indications of prostate surgery, Patients with prostate size between 30 and 70 grams, Completing informed consent form. Exclusion criteria: History of previous prostate surgery with high levels of PSA (Prostate Specific Antigen), Uncontrolled diabetes, History of CVA (cerebral vascular accident) and neurological diseases, Urinary tract obstruction, Addiction, Use of Neurological and Anticholinergic drugs.
Intervention groups
Intervention group: Prostatectomy is performed by open surgery. This procedure is usually performed with spinal anesthesia. Surgery with an incision in the bottom of abdomen done. After removing the prostate, for the control of postoperative bleeding, a catheter is usually inserted into the bladder through the abdomen.Control group: Prostatectomy is performed by TURP method. In this method, with spinal anesthesia, and by passing the camera into the Urethra, The part of the prostate that has caused the obstruction it completely clears and removes. The catheter is inserted for 24 hours after the operation.
Main outcome variables
Benign Prostatic Hyperplasia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180305038956N1
Registration date:2018-03-17, 1396/12/26
Registration timing:registered_while_recruiting
Last update:2018-03-17, 1396/12/26
Update count:0
Registration date
2018-03-17, 1396/12/26
Registrant information
Name
Hormoz Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3626 0000
Email address
h.karami@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of open prostatectomy method And classic TURP (Transurethral Resection of the Prostate) in patients with prostate benign hyperplasia
Public title
Comparison of two prostatectomy methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The classical indications for prostate surgery
Patients with prostate size between 30 and 70 grams
Complete the informed consent form by the patient
Exclusion criteria:
Previous prostate surgery with high PSA (Prostate Specific Antigen) Levels
Uncontrolled diabetes
History of CVA (cerebral vascular accident) and neurological diseases
Urinary tract obstruction
Addiction
Use of neurological and anticholinergic drugs
Age
From 50 years old to 80 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using Sealed envelope
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Sq,Yazd.
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.SSU.REC.1396.143
Health conditions studied
1
Description of health condition studied
Benign prostate hyperplasia
ICD-10 code
N40
ICD-10 code description
Hyperplasia of prostate
Primary outcomes
1
Description
Benign prostatic hyperplasia
Timepoint
One week after surgery, then one month, 3 months and 6 months after surgery
Method of measurement
The amount of Q-Max (Maximum urinary flow) in the uroflowmetry before and after the surgery
Secondary outcomes
1
Description
Bleeding
Timepoint
During surgery, up to a week later
Method of measurement
The rate of receiving blood during and after surgery, and expert examination
2
Description
Wound infection
Timepoint
One week after surgery, then up to 1 month after surgery
Method of measurement
Expert examination
3
Description
Duration of catheterization after surgery
Timepoint
1,3,7 days after surgery
Method of measurement
Expert examination
4
Description
Urethral stricture
Timepoint
1 week, 1 month and 3 months after surgery
Method of measurement
Expert examination and retrograde urethrography
Intervention groups
1
Description
Intervention group: At First, uroflowmetry is done for patients,Due to the size of the prostate and after cystoscopy, they undergo open prostatectomy on the same day. This is usually done with spinal anesthesia. Surgery with an incision at the bottom of the abdomen in the suprapubic area done. After removing the prostate, for the control of postoperative bleeding, a catheter is usually inserted into the bladder through the abdomen. After surgical procedure, Q-Max in uroflowmetry before and after surgery, urinary symptoms (obstruction and excitation) and postoperative complications such as bleeding, receiving blood during and after surgery, postoperative catheterization, wound infection , Urethral stricture and bladder neck and urinary retention in the period of one week, one month, three months and six months will be investigated.
Category
Treatment - Surgery
2
Description
Control group: At First, uroflowmetry is done for patients, Due to the size of the prostate and after cystoscopy, surgery for prostatectomy is performed by the TURP method (transurethral resection of the prostate). In this method, with spinal anesthesia, and by passing the camera into the urethral lumen, the part of the prostate that has caused the obstruction completely clears and removes. After surgical procedure, Q-Max in uroflowmetry before and after surgery, urinary symptoms (obstruction and excitation) and postoperative complications such as bleeding, receiving blood during and after surgery, postoperative catheterization, wound infection , Urethral stricture and bladder neck and urinary retention in the period of one week, one month, three months and six months will be investigated.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Doctor Rahnemoon Hospital
Full name of responsible person
Hormoz Karami
Street address
Shahid Doctor Rahnemoon Hospital, Farrokhi Street, Yazd.
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0000
Email
h.karami@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amir Houshang Mehrparvar
Street address
Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Sq, Yazd.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
ahmehrparvar@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hormoz Karami
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
جراحی کلیه و مجاری ادراری
Street address
Department of Urology , Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0000
Email
h.karami@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hormoz Karami
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urologist
Street address
Department of Urology, Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0000
Email
h.karami@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hormoz Karami
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urologist
Street address
Department of Urology, Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0000
Email
h.karami@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available