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.
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Protocol summary
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
A non- randomized clinical trial with two groups of laparoscopic-hysterectomy and conservative laparoscopic surgery, with parallel groups, double-blind, phase 2 on 100 patients.
A non- randomized 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
کارآزمایی بالینی دارای دو گروه جراحی لاپاراسکوپی-هیسترکتومی و لاپاراسکوپی محافظه کارانه، با گروه های موازی ، دو سویه کور ، تصادفی شده، فاز 2 بر روی 100 بیمار. برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده شد.
کارآزمایی بالینی غیر تصادفی دارای دو گروه جراحی لاپاراسکوپی-هیسترکتومی و لاپاراسکوپی محافظه کارانه، با گروه های موازی، دو سویه کور، فاز 2 بر روی 100 بیمار.
کارآزمایی بالینی غیر تصادفی دارای دو گروه جراحی لاپاراسکوپی-هیسترکتومی و لاپاراسکوپی محافظه کارانه، با گروه های موازی، دو سویه کور ، تصادفی شده، فاز 2 بر روی 100 بیمار. برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده شد.
General information
Observational
Interventional
obsrvintvn
empty
This study was initially designed as a randomized controlled trial, but randomization was not possible due to the ethical obligation to inform patients about the nature and consequences of radical surgery, including hysterectomy. As a result, patients chose their desired surgical approach after comprehensive counseling, which resulted in a practical and preference-based allocation. In addition, in the general information section of the design, it was mentioned from the beginning that randomization was not applicable in the investigator's opinion. Therefore, the randomization protocol was omitted in the abstract section.
This study was initially designed as a randomized controlled trial, but randomization was not possible due to the ethical obligation to inform patients about the nature and consequences of radical surgery, including hysterectomy. As a result, patients chose their desired surgical approach after comprehensive counseling, which resulted in a practical and preference-based allocation. In addition, in the general information section of the design, it was mentioned from the beginning that randomization was not applicable in the investigator's opinion. Therefore, the randomization protocol was omitted in the abstract section.
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این مطالعه در ابتدا به عنوان یک کارآزمایی تصادفی کنترلشده طراحی شده بود، اما به دلیل تعهد اخلاقی برای آگاهسازی بیماران در مورد ماهیت و عواقب جراحی رادیکال، شامل هیسترکتومی، تصادفیسازی امکانپذیر نبود. در نتیجه، بیماران پس از مشاوره جامع، رویکرد جراحی مورد نظر خود را انتخاب کردند که منجر به تخصیص عملی و مبتنی بر ترجیح شد. ضمن اینکه در بخش اطلاعات عمومی طرح از ابتدا اشاره شده بود تصادفی سازی از نظر محقق مصداق ندارد.لذا در بخش چکیده پروتکل تصادفی سازی حذف گردید.
این مطالعه در ابتدا به عنوان یک کارآزمایی تصادفی کنترلشده طراحی شده بود، اما به دلیل تعهد اخلاقی برای آگاهسازی بیماران در مورد ماهیت و عواقب جراحی رادیکال، شامل هیسترکتومی، تصادفیسازی امکانپذیر نبود. در نتیجه، بیماران پس از مشاوره جامع، رویکرد جراحی مورد نظر خود را انتخاب کردند که منجر به تخصیص عملی و مبتنی بر ترجیح شد. ضمن اینکه در بخش اطلاعات عمومی طرح از ابتدا اشاره شده بود تصادفی سازی از نظر محقق مصداق ندارد.لذا در بخش چکیده پروتکل تصادفی سازی حذف گردید.
بررسی کیفیت زندگی و درد مزمن لگن در زنان 40 تا 50ساله مبتلا به اندومتریوز درمان شده به روش هیسترکتومی و سالپنگوافرکتومی لاپاراسکوپی در مقایسه با جراحی لاپاراسکوپی محافظه کارانه
بررسی کیفیت زندگی و درد مزمن لگن در زنان 40 تا 50 ساله مبتلا به اندومتریوز درمان شده به روش هیسترکتومی و سالپنگوافرکتومی لاپاراسکوپی در مقایسه با جراحی لاپاراسکوپی محافظه کارانه
بررسی کیفیت زندگی و درد مزمن لگن در زنان 40 تا 50ساله50 ساله مبتلا به اندومتریوز درمان شده به روش هیسترکتومی و سالپنگوافرکتومی لاپاراسکوپی در مقایسه با جراحی لاپاراسکوپی محافظه کارانه
سن بین ۴۰ تا ۵۰سال
سایقه ی جراحی مرتبط با اندومتریوز نداشته باشد
باروری بیمار کامل هست یا قصد باروری نداشته باشد
vas scor بالای ۸ قبل از جراحی داشته باشد
عدم پاسخ به درمان دارویی مسکن سه ماهه
سن بین ۴۰ تا ۵۰ سال
سایقه ی جراحی مرتبط با اندومتریوز نداشته باشد
باروری بیمار کامل هست یا قصد باروری نداشته باشد
Vas scor بالای ۸ قبل از جراحی داشته باشد
عدم پاسخ به درمان دارویی مسکن سه ماهه
سن بین ۴۰ تا ۵۰سال سایقه ی جراحی مرتبط با اندومتریوز نداشته باشد باروری بیمار کامل هست یا قصد باروری نداشته باشد vasVas scor بالای ۸ قبل از جراحی داشته باشد عدم پاسخ به درمان دارویی مسکن سه ماهه
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 & ....
They have past medical such as hypertention , depretion , Diabet & ....
Age less than 40 years
Intends to be fertile
She has a history of surgery related to endometriosis
Vas score is less than 8
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 less than 40 years Intends to be fertile She has a history of surgery related to endometriosis Vas score is less than 8
بیماری زمینه ای دارد ( قلبی ، فشار خون ، افسردگی ، هر نوع مشکل دیگر * )
سن کمتر از ۴۰ سال
قصد باروری دارد
سابقه ی جراحی در ارتباط با بیماری اندومتریوز دارد
Vas scor کمتر از ۸ دارد
بیماری زمینه ای دارد (قلبی، فشار خون ، افسردگی، هر نوع مشکل دیگر * )
سن کمتر از ۴۰ سال
قصد باروری دارد
سابقه ی جراحی در ارتباط با بیماری اندومتریوز دارد
Vas scor کمتر از ۸ دارد
بیماری زمینه ای دارد (قلبی، فشار خون ، افسردگی، هر نوع مشکل دیگر * ) سن کمتر از ۴۰ سال قصد باروری دارد سابقه ی جراحی در ارتباط با بیماری اندومتریوز دارد Vas scor کمتر از ۸ دارد
Primary outcomes
#1
pain
Pain
painPain
Intervention groups
#1
Intervention group: The group that undergoes hysterectomy and salpingovaphectomy
First Intervention group: The group that undergoes hysterectomy and salpingovaphectomy
First Intervention group: The group that undergoes hysterectomy and salpingovaphectomy
گروه مداخله: گروهی که تحت جراحی هیسترکتومی و سالپنگوافرکتومی قرار می گیرند
گروه مداخله اول: گروهی که تحت جراحی هیسترکتومی و سالپنگوافرکتومی قرار می گیرند
گروه مداخله اول: گروهی که تحت جراحی هیسترکتومی و سالپنگوافرکتومی قرار می گیرند
#2
Intervention group: People who undergo conservative laparoscopic surgery for endometriosis.
Second Intervention group: People who undergo conservative laparoscopic surgery for endometriosis.
Second Intervention group: People who undergo conservative laparoscopic surgery for endometriosis.
گروه مداخله: افرادی که تحت درمان جراحی لاپاراسکوپی محافظه کارانه اندومتریوز قرار میگیرند.
گروه مداخله دوم: افرادی که تحت درمان جراحی لاپاراسکوپی محافظه کارانه اندومتریوز قرار میگیرند.
گروه مداخله دوم: افرادی که تحت درمان جراحی لاپاراسکوپی محافظه کارانه اندومتریوز قرار میگیرند.
Sponsors / Funding sources
#1
empty
Yes
1
empty
empty
Samaneh Rokhgireh
Iran University of Medical Sciences
Samaneh RokhgirehIran University of Medical Sciences
ثمانه رخگیره
دانشگاه علوم پزشکی ایران
ثمانه رخگیرهدانشگاه علوم پزشکی ایران
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Samaneh Rokhgireh
Full name of responsible person - Persian: ثمانه رخگیره
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Sattarkhan- hazrat rasool-akram hospital
Street address - Persian: ستارخان، بیمارستان حضرت رسول اکرم)ص(
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6650 9283
Mobile: +98 911 353 2102
Fax:
Email: Rokhgireh.s@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Samaneh Rokhgireh
Full name of responsible person - Persian: ثمانه رخگیره
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hazrat rasool-akram hospital ,Sattarkhan
Street address - Persian: ستارخان، بیمارستان حضرت رسول اکرم)ص(
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6650 9283
Mobile: +98 911 353 2102
Fax:
Email: Rokhgireh.s@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Samaneh Rokhgireh Full name of responsible person - Persian: ثمانه رخگیره Position - English: Associate professor Position - Persian: دانشیار Latest degree: sub_specialist Area of specialty/work: 49 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Sattarkhan- hazratHazrat rasool-akram hospital ,Sattarkhan Street address - Persian: ستارخان، بیمارستان حضرت رسول اکرم)ص( City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6650 9283 Mobile: +98 911 353 2102 Fax: Email: Rokhgireh.s@iums.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Samaneh Rokhgireh
Full name of responsible person - Persian: ثمانه رخگیره
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Sattarkhan- hazrat rasool-akram hospital
Street address - Persian: ستارخان، بیمارستان حضرت رسول اکرم)ص(
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6650 9283
Mobile: +98 911 353 2102
Fax:
Email: Rokhgireh.s@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Samaneh Rokhgireh
Full name of responsible person - Persian: ثمانه رخگیره
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Sattarkhan- hazrat rasool-akram hospital
Street address - Persian: ستارخان، بیمارستان حضرت رسول اکرم(ص)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6650 9283
Mobile: +98 911 353 2102
Fax:
Email: Rokhgireh.s@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Samaneh Rokhgireh Full name of responsible person - Persian: ثمانه رخگیره Position - English: Associate professor Position - Persian: دانشیار Latest degree: sub_specialist Area of specialty/work: 49 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Sattarkhan- hazrat rasool-akram hospital Street address - Persian: ستارخان، بیمارستان حضرت رسول اکرم)ص(اکرم(ص) City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6650 9283 Mobile: +98 911 353 2102 Fax: Email: Rokhgireh.s@iums.ac.ir Web page address:
Protocol summary
Study aim
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 non- randomized clinical trial with two groups of laparoscopic-hysterectomy and conservative laparoscopic surgery, with parallel groups, double-blind, phase 2 on 100 patients.
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
This study was initially designed as a randomized controlled trial, but randomization was not possible due to the ethical obligation to inform patients about the nature and consequences of radical surgery, including hysterectomy. As a result, patients chose their desired surgical approach after comprehensive counseling, which resulted in a practical and preference-based allocation. In addition, in the general information section of the design, it was mentioned from the beginning that randomization was not applicable in the investigator's opinion. Therefore, the randomization protocol was omitted in the abstract section.
Acronym
IRCT registration information
IRCT registration number:IRCT20191123045476N5
Registration date:2023-11-04, 1402/08/13
Registration timing:registered_while_recruiting
Last update:2025-09-23, 1404/07/01
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:
They have past medical such as hypertention , depretion , Diabet & ....
Age less than 40 years
Intends to be fertile
She has a history of surgery related to endometriosis
Vas score is less than 8
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
First Intervention group: The group that undergoes hysterectomy and salpingovaphectomy
Category
Lifestyle
2
Description
Second 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?
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
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hazrat rasool-akram hospital ,Sattarkhan
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