Protocol summary

Study aim
The purpose of this study was to evaluate the effect of laparoscopic surgical resection of endometriosis lesions in reducing the pain and dyspareunia and sexual quality of life of the individual.
Design
In this study, 30 patients with deep endometriosis who are eligible for inclusion in the study will be included. All patients will undergo laparoscopic surgery and only one group.
Settings and conduct
This study will be carried out on patients with deep endometriosis referring to the Department of Obstetrics and Gynecology Rasoul Akram Hospital.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Married patients Hetrosexual Having sexual dysfunction in 6 months Early diagnosis of endometriosis and chronic pelvic pain associated with endometriosis Having informed consent for inclusion Lack of pelvic pain originating from other organs: Causes gastrointestinal, genitourinary The use of gonadotropins or other hormonal drugs in 3 months Lack of gynecologic malignancies The absence of ultrasound uterine fibroids before surgery no underlying disease, such as cardiovascular diseases, respiratory, renal, hematologic, hepatic, neurological, psychological, The patient is not pregnant. Exclusion criteria: Failure to prove the existence of endometriosis surgery Not wanting to continue the study
Intervention groups
This study is before and after, and all patients will undergo laparoscopic surgery.
Main outcome variables
Pain Quality of Life Female Sexual Ouality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150817023666N8
Registration date: 2018-01-28, 1396/11/08
Registration timing: registered_while_recruiting

Last update: 2018-01-28, 1396/11/08
Update count: 0
Registration date
2018-01-28, 1396/11/08
Registrant information
Name
Abolfazl Mehdizadeh kashi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 216651500
Email address
mehdizadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
iran university of Medical science
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of laparoscopic surgery treatment on sexual dysfunction and quality of life in patients with deep infiltrative endometriosis
Public title
Effect of laparoscopic surgery treatment on sexual dysfunction and quality of life in patients with deep infiltrative endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married patients Hetrosexual Having sexual dysfunction in 6 months Early diagnosis of endometriosis and chronic pelvic pain associated with endometriosis Having informed consent for inclusion Lack of pelvic pain originating from other organs: Causes gastrointestinal, genitourinary dont use of gonadotropins or other hormonal drugs in 3 months Lack of gynecologic malignancies The absence of ultrasound uterine fibroids before surgery no underlying disease, such as cardiovascular diseases, respiratory, renal, hematologic, hepatic, neurological, psychological The patient is not pregnant
Exclusion criteria:
Failure to prove the existence of endometriosis surgery Not wanting to continue the study Pregnancy
Age
From 20 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Ethics committee of Iran University of Medical Sciences
Street address
Rasoul-e-Akram Hospital, Niayesh St, Sattarkhan St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2017-02-22, 1395/12/04
Ethics committee reference number
IR.IUMS.REC 1395.95-04-218-29916

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80.4
ICD-10 code description
Endometriosis of rectovaginal septum and vagina

Primary outcomes

1

Description
qulity of life and sexul function
Timepoint
one year
Method of measurement
questionear

Secondary outcomes

1

Description
pain
Timepoint
one year
Method of measurement
questionear

Intervention groups

1

Description
laprascopic surgery
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-e-Akram Hospital
Full name of responsible person
Abolfazl Mehdizadeh-Kashi
Street address
Rasoul-e-Akram Hospital, Niayesh St, Sattarkhan St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Email
amehdizadehkashi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Mehdizadeh-Kashi
Street address
Rasoul-e-Akram Hospital, Niayesh St, Sattarkhan St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Email
amehdizadehkashi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Assistant Profesor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Niayesh St, Sattarkhan St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Fax
Email
s.rokhgireh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Assistant Profesor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Niayesh St, Sattarkhan St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
Email
s.rokhgireh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Assistant Profesor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Niayesh St, Sattarkhan St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Fax
Email
s.rokhgireh@gmail.com
Web page address

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
All information except personal details
When the data will become available and for how long
After Publication of paper
To whom data/document is available
All
Under which criteria data/document could be used
more research
From where data/document is obtainable
Dr. Rokhgireh
What processes are involved for a request to access data/document
Sending Email For Request Information
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