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Evaluation of Lipid Profiles and Plasma Vitamin D Levels in Endometriosis Patients' beforeand after Radical Laparoscopic Surgery

Protocol summary

Study aim
Evaluation of Lipid Profiles and Plasma Vitamin D Levels in Endometriosis Patients' before and after Radical Laparoscopic Surgery
Design
Clinical trial, before and after, includes 29 patients
Settings and conduct
This study is a clinical trial with the participation of all patients with endometriosis who will be referred to Shohada Tajrish Hospital from August 1, 2019 to June 21, 2020 for surgery. Data were collected using a questionnaire including age, BMI, number of pregnancies, abortion, delivery, painful menstruation, pelvic pain ,dyspareunia, , intermittent spotting, familial history of endometriosis, history of Pelvic infections are contraceptive pills. In order to measure serum lipid profiles and vitamin D levels after 12 hours of fasting, 5 cc of venous blood samples from both groups will be taken before surgery. In patients with endometriosis, two months after surgery, the level of lipid profile and vitamin D will be measured again. Profile lipid contains cholesterol, triglycerides, LDL, and HDL.
Participants/Inclusion and exclusion criteria
Entry requirements: endometriosis patients; 15- 45 years old; no pregnancy; laparoscopic Surgery candidate; no drug use, especially OCP, from 3 months before surgery; no drug use, until 2 months after surgery. Exclusion conditions: systemic medical conditions including high blood pressure and diabetes; hypothyroidism & hyperthyroidism; pregnancy; BMI> 30; hyperlipidemia; smoking; drinking.
Intervention groups
Endometriosis patients who are candidates for radical laparoscopic surgery
Main outcome variables
The level of lipid profiles in endometriosis patients after laparoscopic radical surgery changes (HDL decreases and the rest of the lipid profiles increase); Plasma vitamin D levels increase in patients with endometriosis after laparoscopic radical surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190529043753N1
Registration date: 2019-07-25, 1398/05/03
Registration timing: prospective

Last update: 2019-07-25, 1398/05/03
Update count: 0
Registration date
2019-07-25, 1398/05/03
Registrant information
Name
Mohadese Alemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7721 0526
Email address
alemi_mohadese@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-01, 1398/05/10
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Lipid Profiles and Plasma Vitamin D Levels in Endometriosis Patients' beforeand after Radical Laparoscopic Surgery
Public title
Evaluation of Lipid Profiles and Plasma Vitamin D Levels in Endometriosis Patients' beforeand after Radical Laparoscopic Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Endometriosis patients 15- 45 years old No pregnancy Laparoscopic Surgery candidate No drug use, especially ocp, from 3 months before surgery No drug use, until 2 months after surgery
Exclusion criteria:
Systemic medical conditions including high blood pressure and diabetes hypothyroidism & hyperthyroidism pregnancy BMI> 30 Hyperlipidemia smoking Drinking
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 29
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Ghods Town (West), Between South Falamak and Zarafshan, Iran-Iran Street - Central Headquarters of the Ministry of Health and Medical Education, block A, thirteenth floor
City
tehran
Province
Tehran
Postal code
۱۴۱۹۹۴۳۴۷۱
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.SBMU.MSP.REC.1398.075

Health conditions studied

1

Description of health condition studied
endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis

Primary outcomes

1

Description
Serum vitamin D levels in people with endometriosis before and after surgery
Timepoint
Before Surgery and 2 months after surgery
Method of measurement
Take 5 cc blood sample after 12 hours of fasting and report on ng / ml

2

Description
Serum cholesterol levels in people with endometriosis before and after surgery
Timepoint
Before Surgery and 2 months after surgery
Method of measurement
Take 5 cc blood sample after 12 hours of fasting and report on mg / dl

3

Description
Serum triglyceride levels in people with endometriosis before and after surgery
Timepoint
Before Surgery and 2 months after surgery
Method of measurement
Take 5 cc blood sample after 12 hours of fasting and report on mg / dl

4

Description
Serum LDL levels in people with endometriosis before and after surgery
Timepoint
Before Surgery and 2 months after surgery
Method of measurement
Take 5 cc blood sample after 12 hours of fasting and report on mg / dl

5

Description
Serum HDL levels in people with endometriosis before and after surgery
Timepoint
Before Surgery and 2 months after surgery
Method of measurement
Take 5 cc blood sample after 12 hours of fasting and report on mg / dl

Secondary outcomes

empty

Intervention groups

1

Description
Radical Laparoscopic Surgery
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Mohadese Alemi
Street address
shohadaye tajrish hospital, shahrdari st.Tajrish Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9201
Email
Pr_shohada@sbmu.ac.ir
Web page address
http://shmc.sbmu.ac.ir/index.jsp?siteid=90

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zarghi Afshin
Street address
Shahid Beheshti University of Medical Sciences, Yemen street, Shahid Araji St., Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohadese Alemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shohadaye tajrish hospital, shahrdari st.Tajrish Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198993415
Phone
+98 21 2274 9201
Email
alemi_mohadese@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Noori Behnaz
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shohadaye tajrish hospital, shahrdari st.Tajrish Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2247 9201
Email
Nouri@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alemi Mohadese
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shohadaye tajrish hospital, shahrdari st.Tajrish Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2247 9201
Email
Alemi_mohadese@sbmu.ac.ir

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
Yes - There is 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
Yes - There is 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
Serum levels of vitamin D and lipid profile before surgery and 6 to 8 weeks after surgery
When the data will become available and for how long
6 months
To whom data/document is available
Researchers and Gynecologist
Under which criteria data/document could be used
For research and clinical use
From where data/document is obtainable
Dr. Behnaz Nouri by email Dr. Mohaddeh Alami by email
What processes are involved for a request to access data/document
Contact the researcher
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