Investigating the quality of life and chronic pelvic pain in 40-50-year-old women with endometriosis treated by hysterectomy and laparoscopic salpingo-ferectomy compared to conservative laparoscopic surgery.
Determining quality of life and chronic pelvic pain in 40-50-year-old women with endometriosis treated by laparoscopic hysterectomy and salpingoephrectomy compared to conservative laparoscopic surgery
Design
A clinical trial with two groups of laparoscopic-hysterectomy and conservative laparoscopic surgery, with parallel groups, double-blind, randomized, phase 2 on 100 patients. The rand function of Excel software was used for randomization
Settings and conduct
This study will be conducted in Hazrat Rasool Akram Hospital. The written consent form is signed and dated. Endometriosis patients undergoing laparoscopic surgery undergo two types of Hysterectomy and salpingovaphectomy and conservative laparoscopy. Study 2 is blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age between 40 and 50 years Do not have surgery related to endometriosis 2. The patient's fertility is complete or she has no intention of fertility Have a 3. vas score above 8 before surgery
4. Failure to respond to three-month analgesic drug treatment
Exclusion criteria:
1. has an underlying disease (heart, blood pressure, depression, any other type of problem)
2. Age less than 40 years
3. Intends to be fertile, has a history of surgery related to endometriosis
4. Vas score is less than 8
Intervention groups
1. The group that undergoes hysterectomy and salpingovaphectomy
2. People who undergo conservative laparoscopic surgery for endometriosis.
Main outcome variables
Pain, quality of life and sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191123045476N5
Registration date:2023-11-04, 1402/08/13
Registration timing:registered_while_recruiting
Last update:2023-11-04, 1402/08/13
Update count:1
Registration date
2023-11-04, 1402/08/13
Registrant information
Name
Samaneh Rokhgireh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
rokhgireh.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the quality of life and chronic pelvic pain in 40-50-year-old women with endometriosis treated by hysterectomy and laparoscopic salpingo-ferectomy compared to conservative laparoscopic surgery.
Public title
Investigating the quality of life and pain of endometriosis patients treated by hysterectomy and laparoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 and 50 years
Do not have surgery related to endometriosis
The patient's fertility is complete or she has no intention of fertility
Have a vas score above 8 before surgery
Failure to respond to three-month analgesic drug treatment
Exclusion criteria:
Age less than 40 years
intends to be fertile
He has a history of surgery related to endometriosis
Vas score is less than 8
They have past medical such as hypertention , depretion , Diabet & ....
Age
From 40 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main researcher and the data analyst will be blinded to the assignment of the study groups; The patients are given a special code and the analyst does not know which group A and B are, and the main researcher is not involved in the selection of patients and does not know which group the patient who is undergoing surgery belongs to.
Placebo
Not used
Assignment
Parallel
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
Iran University of medical sciences, Hammat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2022-11-15, 1401/08/24
Ethics committee reference number
IR.IUMS.FMD.REC.1401.428
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80.0
ICD-10 code description
Endometriosis of uterus
Primary outcomes
1
Description
pain
Timepoint
3 month before surgery and 6 month & 12 month after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group that undergoes hysterectomy and salpingovaphectomy
Category
Lifestyle
2
Description
Intervention group: People who undergo conservative laparoscopic surgery for endometriosis.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Samaneh Rokhgireh
Street address
Rasoul Akram Hospital, Mansouri Street, Starkhan, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Email
rokhgireh.s@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Street address
Rasoul Akram Hospital, Mansouri Street, Starkhan, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 911 353 2102
Email
rokhgireh.s@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Samaneh Rokhgireh
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
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sattarkhan- hazrat rasool-akram hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
Email
Rokhgireh.s@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sattarkhan- hazrat rasool-akram hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
Email
Rokhgireh.s@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sattarkhan- hazrat rasool-akram hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
Email
Rokhgireh.s@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After the article is published, confidential information such as patient and hospital details will be removed and other information will be provided to the researchers.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Medical specialists
Under which criteria data/document could be used
Medical professionals can access the data for research purposes.
From where data/document is obtainable
Refer to the email of the responsible author (Samaneh Rokhgireh, email: s.rokhgireh@gmail.com )
What processes are involved for a request to access data/document
Official and academic email to the responsible author