Comparison of erectile function following nerve-sparing radical cystectomy using two method of ligating posterior bladder pedicle: Ligasure versus stapling device
Design
Randomized, blinded clinical trial with parallel groups
Settings and conduct
This study was performed in a university hospital called Al-Zahra, Isfahan, Iran. Before surgery all participants were asked to fill Erectile Function Questionnaire. The patients were randomized into two groups: in group one, posterior bladder pedicle was ligated using LigaSure, but in group two, posterior bladder pedicle was ligated by stapling device. Six months after the surgery, the patients were asked to refill the questionnaire.
Participants/Inclusion and exclusion criteria
Male under 70 year-old of age with muscle invasive bladder cancer candidate for radical cystectomy with orthotropic urinary diversion without prior severe erectile dysfunction
Intervention groups
Group 1: ligation of posterior bladder pedicle by LigaSure
Group 2: ligation of posterior bladder pedicle by stapling device
Main outcome variables
The status of erectile function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150420021869N2
Registration date:2019-05-21, 1398/02/31
Registration timing:retrospective
Last update:2019-05-21, 1398/02/31
Update count:0
Registration date
2019-05-21, 1398/02/31
Registrant information
Name
Farshad Gholipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6636 2089
Email address
f-gholipour@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
2016-05-25, 1395/03/05
Actual recruitment end date
2017-05-22, 1396/03/01
Trial completion date
2018-05-22, 1397/03/01
Scientific title
LigaSure versus Stapling Device for Ligation of Bladder Pedicle on Erectile Function after Nerve Sparing Radical Cystectomy
Public title
LigaSure versus Stapling Device for Ligation of Bladder Pedicle on Erectile Function after Nerve Sparing Radical Cystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
male patients
younger than 70 years
suffering muscle invasive bladder cancer
candidate for radical cystectomy with orthotropic urinary diversion
Exclusion criteria:
patients with severe erectile dysfunction
Age
To 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Actual sample size reached:
63
More than 1 sample in each individual
Actual sample size in each individual:
1
Erectile function
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups. Simple randomization was performed. Randomization unit was individual. For allocation of the participants, a computer-generated list of random numbers was used. Since patients underwent general anesthesia, they were not aware of the device being used for ligating posterior bladder pedicle. Blinding of the surgeon was not feasible. Data regarding erectile function before and after the surgery was collected and analyzed by researchers blinded to the intervention performed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients were unaware of how the posterior bladder pedicle is closed. The researcher was blinded to the procedure by which the precipitants was underwent. The main surgeon was aware of the method of pedicle closure and blinding was not feasible.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
8168814193
Approval date
2016-09-27, 1395/07/06
Ethics committee reference number
IR.mui.REC.1395.3.516
Health conditions studied
1
Description of health condition studied
Bladder cancer
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
2
Description of health condition studied
Erectile dysfunction
ICD-10 code
N52
ICD-10 code description
Male erectile dysfunction
Primary outcomes
1
Description
Erectile function score in International Index of Erectile Function (IIEF) questionnaire
Timepoint
Before intervention, 6 and 12 months after intervention
Method of measurement
International Index of Erectile Function (IIEF)
Secondary outcomes
empty
Intervention groups
1
Description
In this group, endo GIA stapling device was used to ligate bladder vascular pedicles. After developing plane between rectum and bladder at posterior aspect and freeing retzius space at lateral aspects, bladder pedicles are exposed and ligated using 60 mm endo GIA stapling device, which is a non-absorbable stapler. The only difference between two intervention groups is the technique of bladder pedicle ligation.
Category
Treatment - Surgery
2
Description
In this group, LigaSure was used to ligate bladder vascular pedicles. After developing plane between rectum and bladder at posterior aspect and freeing retzius space at lateral aspects, bladder pedicles are exposed and ligated using LigaSure, which is a bipolar electrocoagulation system. The only difference between two intervention groups is the technique of bladder pedicle ligation.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Farshad Gholipour
Street address
Soffeh Bulevard
City
Isfahan
Province
Isfehan
Postal code
817467573
Phone
+98 31 3620 2020
Fax
+98 31 3669 1510
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Web page address
http://research.mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Gholipourr
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Mardavij
City
Isfahan
Province
Isfehan
Postal code
8168814193
Phone
+98 31 3669 7898
Email
f-gholipour@student.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Gholipourr
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Mardavij
City
Isfahan
Province
Isfehan
Postal code
8168814193
Phone
+98 31 3669 7898
Email
f-gholipour@student.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Gholipourr
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Mardavij
City
Isfahan
Province
Isfehan
Postal code
8168814193
Phone
+98 31 3669 7898
Email
f-gholipour@student.tums.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
No more data
When the data will become available and for how long