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Evaluation of ovarian function after hysterectomy with and without salpingectomy

Protocol summary

Summary
Ovarian cancer is the 5th most common cancer in terms of mortality and the most common gynecologic cancer in women. Many studies have shown that most fatal cancers of ovarian Serous Carcinoma is formed in the distal mucosal of fallopian tube and then to the ovaries and other pelvic organs to be enhanced. Due to this, it Can be hypothesized That The removal of the fallopian tubes reduce the amount of ovarian cancer in the future and the mortality rate of these malignancies. the best opportunity to do this operation, the women who want to undergo hysterectomy for benign reasons. Put this issue because there is no good screening test for ovarian cancer will be of great importance. Also in hysterectomy without salpingectomy there is postoperative complications for patients, including those which may be referred to hydrosalpinx.On the other hand salpingectomy and its effect on ovarian function and hormones maybe can cause premature menopause and sexual dysfunction, psychiatric disorders and cardiovascular disorders, that this create the sense to do this surgery remains controversial.This study aimed to apply in all cases of hysterectomy specimen for routine without worrying about adverse effects on ovarian function in order to reduce the risk of ovarian cancer and related complications such as hydrosalpinx. In htis study that is a randomized not blinded clinical trial, 86 adolescent patients undergoing hysterectomy to benign causes who are not menopausal and agreed to participate in the study were randomly divided into two groups, the control group are just undergoing hysterectomy and the intervention group who undergoing hysterectomy with salpingectomy at the same time. Disagreement of patients or the impossibility of measuring the levels of FSH, LH and AMH or malignancy are exclusion criteria. All patients were treated by a surgeon.Demographics informations such as; age, race, height, weight, FSH, LH and AMH levels as a marker for ovarian function measured in the preoperative visit, will be recorded. After 6 months we will check the level of FSH , LH and AMH and compare with prior data.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112025139N1
Registration date: 2016-09-26, 1395/07/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-26, 1395/07/05
Registrant information
Name
fariba behnamfar
Name of organization / entity
medeical school of isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 5555
Email address
behnamfar_fa@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of ovarian function after hysterectomy with and without salpingectomy
Public title
Evaluation of ovarian function after uterine resection with and without resection of uterine tubes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Women candidate for hysterectomy because of benign reasons that will be admitted to Alzahra and Beheshti Hospitals in 2016-2017; the patients agreed to participate in the study; No history of menopause or cancer Exclusion criteria: Impossibility of measuring serum markers before or after Surgery for Various reasons; malignancy; cancelling of operation
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
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
Isfahan University of Medical Sciences
Street address
Technology and Research Department, Building 4 , Headquarters of Medical Sciences University, Daneshgah Boulevard, Isfahan
City
Isfahan
Postal code
81745-319
Approval date
2015-07-14, 1394/04/23
Ethics committee reference number
Ir.mui.rec.1394.3.319

Health conditions studied

1

Description of health condition studied
Ovarian cancer
ICD-10 code
C57.8
ICD-10 code description
Overlapping lesion of female genital organs

Primary outcomes

1

Description
FSH
Timepoint
Before surgery, 6 months after surgery
Method of measurement
Chemiluminescence method with Elecsyscobas e411

2

Description
LH
Timepoint
Before surgery, 6 months after surgery
Method of measurement
Chemiluminescence method with Elecsyscobas e411

3

Description
AMH
Timepoint
Before surgery, 6 months after surgery
Method of measurement
Chemiluminescence method with Elecsyscobas e411

Secondary outcomes

empty

Intervention groups

1

Description
Bilateral salpingectomy in intervention group (surgical removal of a fallopian tubes during hystrectomy by laparatomy)
Category
Treatment - Surgery

2

Description
Not to do salpingectomy in control group (preservation of fallopian tubes)
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Hajar Jabbari MD.
Street address
Alzahra Hospital, Soffe ST,Isfahan
City
Isfahan

2

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Hajar Jabbari MD.
Street address
Motahari St, Felezi Bridge, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mrs. Toghiani
Street address
Technology And Research Department, Building 4. Headquarters of Medical Sciences University, Daneshgah Boulevard, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Hajar Jabbari MD.
Position
Assistant of Gynecology and Obstetrics
Other areas of specialty/work
Street address
88 Building, Bijan Alley, Mohtasham Kashani St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3624 3342
Fax
Email
jabarihasti@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fariba Behnamfar MD.
Position
Fellowship of onchology
Other areas of specialty/work
Street address
Alzahra Hospital, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
f_behnamfar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hajar Jabbari MD.
Position
Assistant of Gynecology and obstetrics
Other areas of specialty/work
Street address
88 Building, Bijan Alley, Mohtasham Kashani St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3624 3342
Fax
Email
jabarihasti@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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