Study the results of pelvic floor prolapsed repair in vaginal surgery (anterior colporrhaphy with mesh and Sacrospinous ligament suspension) and abdominal approach (Sacropexy and Hysteropexy)
Compare the results of pelvic floor prolapsed repair in vaginal surgery (anterior colporrhaphy with mesh and Sacrospinous ligament suspension) and abdominal approach (Sacropexy and Hysteropexy)
Design
The study population is divided into two parts of the intervention group. Group one (: Patients undergoing pelvic floor prolapse surgery in vaginal (anterior corpuscular with mesh and Sacroospinosis) and group two Patients undergoing pelvic floor prolapse surgery in vaginal (anterior corpuscular with mesh and Sacroospinosis) with 25 populations in each group. They will be selected among the patients (female) referred to the clinic Al-Zahra Hospital in Tabriz by Random sampling method.
Settings and conduct
The study population is divided into two parts of the intervention group. Group one (: Patients undergoing pelvic floor prolapse surgery in vaginal (anterior corpuscular with mesh and Sacroospinosis) and group two Patients undergoing pelvic floor prolapse surgery in vaginal (anterior corpuscular with mesh and Sacroospinosis) with 25 populations in each group. They will be selected among the patients (female) referred to the clinic Al-Zahra Hospital in Tabriz by Random sampling method.
Participants/Inclusion and exclusion criteria
In this study, women referred to Al-Zahra clinic who have pelvic floor disease in Grade I and II will be examined in the absence of previous surgery history
Intervention groups
1- Intervention group one: Patients undergoing pelvic floor prolapse surgery in vaginal (anterior corpuscular with mesh and Sacroospinosis )
2- Patients undergoing abdominal surgery (Sacropaxia and Hysteropexy).
Main outcome variables
Comparison of the incidence of dyspareunia in two methods
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130306012728N6
Registration date:2018-07-29, 1397/05/07
Registration timing:registered_while_recruiting
Last update:2018-07-29, 1397/05/07
Update count:0
Registration date
2018-07-29, 1397/05/07
Registrant information
Name
Sakineh Hajebrahimi
Name of organization / entity
Urology Department, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7328
Email address
ebrahimis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-01, 1397/04/10
Expected recruitment end date
2019-04-30, 1398/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the results of pelvic floor prolapsed repair in vaginal surgery (anterior colporrhaphy with mesh and Sacrospinous ligament suspension) and abdominal approach (Sacropexy and Hysteropexy)
Public title
Study the results of pelvic floor prolapsed repair in vaginal surgery (anterior colporrhaphy with mesh and Sacrospinous ligament suspension) and abdominal approach (Sacropexy and Hysteropexy)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pelvic floor prolapse three or four grade
Dissatisfaction or non-response to non-surgical treatments
Satisfaction to participate in the study
Exclusion criteria:
There is an anatomical problem that does not allow surgery to be performed in a way
There is a risk factor or specific disease that does not allow surgery to be performed in either of the two methods
History of previous pelvic floor prolapse surgery
dissatisfaction to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with using a random number table based on the case number, will be randomly assigned into two intervention and control groups
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 Tabriz University Of Medical Sciences.
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
33357313
Approval date
2018-04-23, 1397/02/03
Ethics committee reference number
IR.TBZMED.REC.1397.094
Health conditions studied
1
Description of health condition studied
Pelvic floor prolapse
ICD-10 code
N81.8
ICD-10 code description
Other female genital prolapse
Primary outcomes
1
Description
Evaluation of duration of hospitalization in pelvic floor prolapse surgery in two methods
Timepoint
Duration of hospitalization
Method of measurement
Questionnaire
2
Description
Evaluation of surgical duration of pelvic floor prolapse in two methods
Timepoint
Duration of surgery
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Comparison of the incidence of dyspareunia in two methods
Timepoint
Follow up every month until three months after surgery
Method of measurement
Calling and completing the questionnaire
Intervention groups
1
Description
Intervention group:
Category
Treatment - Surgery
2
Description
Intervention group:
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Prof. Sakineh Hajebrahimi
Street address
Alzahra Hospital, South Artesh St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Prof. Sakineh Hajebrahimi
Position
Professor of Urology, Fellowship in Female Urology
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Department of Urology,Imam Reza educational and treatment center, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
04151666-14756
Phone
+98 984133357328
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Prof. Sakineh Hajebrahimi
Position
Professor of Urology, Fellowship in Female Urology
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Department of Urology,Imam Reza educational and treatment center, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
04151666-14756
Phone
+98 984133357328
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Prof. Sakineh Hajebrahimi
Position
Professor of Urology- Fellowship in Female Urology
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Department of Urology,Imam Reza educational and treatment center, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
04151666-14756
Phone
+98 984133357328
Email
lahroudin@gmail.com
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