Pelvic organ prolapsed is main cause of disability of women with multi vaginal delivery. The common surgical approach for therapy is vaginal hysterectomy. In elderly women with medical problem who do not wish to be sexually active, partial colpocleisis (lefotrh) is a simple, safe, and effective surgical procedure that reliably relieves these women of their symptoms without the potential hazards of vaginal hysterectomy.
In this clinical trial study we use modified lefotrh procedure for repair of pelvic organ prolapsed with leave one lateral vaginal channel larger than other, so it suitable for sexual activity.In this study, patients were divided into two groups, surgical vaginal hysterectomy (control) and surgical modified partial colpoclisis(case).Patient with uterine prolapsed older than 65 years old without other pathologic problem who wish to be sexually active were chosen. Duration, complication, efficacy and patient satisfactory of modified partiel colpoclesis for severe pelvic organ prolapsed comparison with vaginal hysterectomy at Alzahra hospital of Tabriz university of medical sciences.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060811205N2
Registration date:2013-10-24, 1392/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-24, 1392/08/02
Registrant information
Name
Dr.Zahra Fardiazar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
fardiazar@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tabriz University of Medical Sciences
Expected recruitment start date
2013-08-11, 1392/05/20
Expected recruitment end date
2015-07-11, 1394/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of modified partial colpoclisis in elderly women with sever pelvic organ prolapse and sexual activity
Public title
Evaluation of modified partial colpoclisis in elderly women with sever pelvic organ prolapse and sexual activity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age above 65 years old; no indication for hysterectomy
total uterine prolaps
exclusion criteria: medical conditions lead to lower abdomen pressure such as Constipation Chronic persistent cough; Patients Who Want to Stop Their treatment
Age
From 65 years old to 90 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Tabriz University of Medical Ssciences, Golgasht avenue
City
Tabriz
Postal code
Approval date
2012-05-15, 1391/02/26
Ethics committee reference number
2371/4/5
Health conditions studied
1
Description of health condition studied
Female genital prolapse
ICD-10 code
N81.8
ICD-10 code description
Old laceration of muscles of pelvic floor
Primary outcomes
1
Description
Comparative effects of short-term and medium-term (first year) in two methods.
Timepoint
During the first year after surgery.
Method of measurement
Questionnaire
2
Description
Duration of vaginal hysterectomy and colpoclisis
Timepoint
During surgery
Method of measurement
check list
3
Description
Assess patients' satisfaction with sexual function
Timepoint
During the first year after surgery.
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
modified partial colpoclisis
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr.Zahra Fardiazar
Street address
Alzahra hospital, South Artesh ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Scienes
Full name of responsible person
Dr.Ali Reza Ostad Rahimi
Street address
Tabriz university of medical sciences, Golgasht street
City
Tabriz
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 Scienes