This study is designed for investigation the therapeutic effect of cryotherapy with and without nobothian cyst drainage in 144 women with chronic cervicitis. Patients are married women who have children with out history of immune deficiency diseases and cancers especially genitalia ones. Pap smear and culture will be taken from patients to rule out CIN(cervical intraepithelial neoplasm). If pap smears and cultures are normal, treatment will be started. Patients are divided in to two groups, each one included 72 women randomly. In one group cryotherapy will be done after nobothian cyst drainage and in the other group cryotherapy will be done without nobothian cyst drainage. Patients will be examined once a months for investigating therapeutic effects like abdominal pain, dysuria, frequency, dyspareunia, vaginal discharge and bleeding after intercourse for three months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022821653N4
Registration date:2017-03-10, 1395/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-10, 1395/12/20
Registrant information
Name
Athar Rasekh Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5432 6602
Email address
a.rasekh@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahrom University of Medical Sciences
Expected recruitment start date
2015-06-25, 1394/04/04
Expected recruitment end date
2016-06-24, 1395/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the therapeutic effect of cervix cryotherapy with and without nobothian cyst drainage in the treatment of women with chronic cervicitis
Public title
Comparing the therapeutic effect of cervix cryotherapy with and without nobothian cyst drainage in the treatment of women with chronic cervicitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included a married woman who has a child and enters the study after knowing all aspects of the study with satisfaction.
Exclusion criteria included the presence of certain immune deficiency diseases, especially cancers of the reproductive system and non-existence of the patient satisfaction for entering the study.
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
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 Jahrom University of Medical Sciences
Street address
Motahari boulevard, Jahrom University of Medical Sciences, Jahrom
City
Jahrom
Postal code
Approval date
2016-01-30, 1394/11/10
Ethics committee reference number
IR.JUMS.REC.1394.163
Health conditions studied
1
Description of health condition studied
chronic cervicitis
ICD-10 code
N72
ICD-10 code description
Inflammatory disease of cervix uteri
Primary outcomes
1
Description
Hypogastric pain
Timepoint
Visiting the patient once a month for three months after intervention
Method of measurement
check list, patients expression
2
Description
Dysuria
Timepoint
Visiting the patient once a month for three months after intervention
Method of measurement
check list, patients expression
3
Description
Dyspareunia
Timepoint
Visiting the patient once a month for three months after intervention
Method of measurement
check list, patients expression
4
Description
green or yellow vaginal discharge
Timepoint
Visiting the patient once a month for three months after intervention
Method of measurement
check list, vaginal examination
5
Description
bleeding after intercourse
Timepoint
Visiting the patient once a month for three months after intervention
Method of measurement
check list, patients expression
6
Description
Mucopurulent vaginal discharge
Timepoint
Visiting the patient once a month for three months after intervention
Method of measurement
check list, vaginal examination
Secondary outcomes
1
Description
cervix stenosis
Timepoint
once a month for three months
Method of measurement
check list, vaginal examination
2
Description
uterus adhesion
Timepoint
visting the pateint once a month for three months
Method of measurement
check list, sonography
3
Description
uterus prolapse
Timepoint
visting the pateint once a month for three months
Method of measurement
check list, vaginal examination
4
Description
spotting
Timepoint
visting the pateint once a month for three months
Method of measurement
check list, patients expression
5
Description
hypogastric pain
Timepoint
visting the pateint once a month for three months
Method of measurement
check list, patients expression
6
Description
infertility
Timepoint
once a month for three months
Method of measurement
check list, patients follow up
7
Description
idiopathic abortion
Timepoint
visting the pateint once a month for three months
Method of measurement
check list, patients follow up
8
Description
making a mistake in diagnosis with ectropion or tissue damage
Timepoint
visting the pateint once a month for three months
Method of measurement
check list, patients follow up
Intervention groups
1
Description
Interventional group one, cryotherapy without nabothian cyst drainage
Category
Treatment - Surgery
2
Description
Interventional group two, cryotherapy is done after nobothian cyst drainage with needle 5 cc in controlled and healthy
procedure
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Peymanieyeh clinic related to Jahrom University of Medical Sience
Full name of responsible person
Doctor Athar Rasekh Jahromi
Street address
Peymanieyeh chinic, Peymanieyeh street, Jahrom
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Jahrom University of Medical Sience
Full name of responsible person
Doctor Kavous Solhjo
Street address
Jahrom University of Medical Sience, Motahari boluvar, Jahrom
City
Jahrom
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, Jahrom University of Medical Sience
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sience
Full name of responsible person
Doctor kavous Solhjo
Position
PHD of Microbiology
Other areas of specialty/work
Street address
Motahari boulevard, Jahrom University of Medical Sience
City
Jahrom
Postal code
Phone
+98 79 1334 0406
Fax
Email
sohjo@jums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sience
Full name of responsible person
Doctor Athar Rasekh Jahromi
Position
Obstertrian and gyncologist
Other areas of specialty/work
Street address
The 22 bahman street, Jahrom
City
Jahrom
Postal code
Phone
+98 917 191 1454
Fax
Email
Drrasekh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sience
Full name of responsible person
Fatemeh Kargarfard
Position
Medical student
Other areas of specialty/work
Street address
Alley5, Fard asadi avenue, Jahrom
City
Jahrom
Postal code
7416653134
Phone
+7 154330990
Fax
Email
fatemehkargarfard@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)