Comparison of efficacy and complications of two laparoscopic sacrocolpopexy and secretion of ligament sacrospinous in vaginal prolapse
Design
Clinical trials with parallel groups were randomly assigned to each group
Settings and conduct
All patients were operated in two groups in the Urology Operative Hospital of Bahonar Hospital in Kerman.
The first group was placed in the supine position with a laparoscopic device through the abdomen and the second group in the lithotomy position through the vagina
Participants/Inclusion and exclusion criteria
Entry criteria included
1 - Age 18-75 years
2. grade two or more cervical prolapse in the examination
3-Symptom of prolapse
4. No response to conservative treatment
5. Demand for surgical treatment for the treatment of prolapse
And exclusion criteria included
1. There is a contraindication for major surgery or anesthesia
2. There is any malignancy in the urinary system, the vulvovaginal genital area
3. Proactive urinary tract infection, genital and pelvic infection
4. Pregnancy and breastfeeding
5- History of sensitivity to the synthetic mesh
Intervention groups
Group 1: Surgical Laparoscopic sacrocolpopexy Surgery through the abdomen that the vaginal vault is fixed through the mesh with non-absorbance sutures to the sacrum bone.
Group 2: Ligament sacrospinous fixation through vagina.vaginal vult fixed through mesh to ligament sacrospinous .
Main outcome variables
symptoms and quality of life
complications of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180106038231N1
Registration date:2019-11-09, 1398/08/18
Registration timing:retrospective
Last update:2019-11-09, 1398/08/18
Update count:0
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
Ehsan Zemanati yar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3244 8636
Email address
a.danesh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Laparoscopic sacrocolpopexy versus sacrospinous ligament fixation for treatment of prolapse of the apical segment of the vagina
Public title
surgery for prolapse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-75 years
Cervical prolapse
Symptomatic prolapse
no response to consevative treatment
Demand for surgical treatment for the treatment of prolapse
Exclusion criteria:
contraindication for surgery
malignancy
Active genitourinary tract infection
pregnancy and breastfeeding
hypersensitivity to mesh
Age
From 18 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
blocked randomized :
The block randomization method will be used in which both groups are completed in parallel, patient 1 in group 1 and patient 2 in group 2, patient 3 again in group 1 and patient 4 in group 2. Given so both groups will be complete
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Shahid Bahonar Hospital in Kerman, Shahid Gharani St.
City
Kerman
Province
Kerman
Postal code
7619714368
Approval date
2018-06-08, 1397/03/18
Ethics committee reference number
IR.KMU.REC.1397.094
Health conditions studied
1
Description of health condition studied
Apical vaginal prolapse
ICD-10 code
N99.3
ICD-10 code description
Prolapse of vaginal vault after hysterectomy
Primary outcomes
1
Description
sign and symptom
Timepoint
Follow up 12 months after surgery
Method of measurement
Using a questionnaire and examination
2
Description
quality of life
Timepoint
Follow up 12 months after surgery
Method of measurement
Using a questionnaire and examination
3
Description
sexual function
Timepoint
Follow up 12 months after surgery
Method of measurement
Using a questionnaire and examination
4
Description
complication
Timepoint
Follow up 12 months after surgery
Method of measurement
Using a questionnaire and examination
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: A group of patients undergoing laparoscopic sacrocolpopexy
Category
Treatment - Surgery
2
Description
Intervention group: the second group of patients undergoing surgical stabilization of sacrospainous ligament through the vagina
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital in Kerman
Full name of responsible person
Zemanati Yar Ehsan
Street address
Shahid Gharani Street
City
Kerman
Province
Kerman
Postal code
7619714368
Phone
+98 34 3223 5011
Email
drehsan.zemanati@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Abas Pardakhti
Street address
Kerman University of Medical Sciences, Haft Bagh
City
Kerman
Province
Kerman
Postal code
14678213675
Phone
+98 34 3133 6086
Email
a.pardakhti@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Zemanati Yar Ehsan
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Shahid Bahonar Hospital in Kerman
City
Kerman
Province
Kerman
Postal code
7619714368
Phone
+98 34 3223 5011
Email
drehsan.zemanati@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zemanati Yar Ehsan
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Shahid Bahonar Hospital in Kerman, Shahid Gharani St.
City
Kerman
Province
Kerman
Postal code
7619714368
Phone
+98 34 3223 5011
Email
drehsan.zemanati@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ehsan Zemanati yar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Gharani st bahonar hospital
City
Kerman
Province
Kerman
Postal code
7619714368
Phone
+98 34 3244 8636
Fax
Email
drehsan.zemanati@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total quality of life data and symptoms and complications after being unidentifiable can be shared
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers at universities
Under which criteria data/document could be used
Conditions under academic rules
From where data/document is obtainable
drehsan.zemanati@yahoo.com
What processes are involved for a request to access data/document
The university approval process involves the approval of the group and the research committee of the university