The comparison of treatment with dienogest and contraceptive oral pills on the improvement of pain, and quality of life in surgery patients with advanced endometriosis
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Protocol summary
Patients with advanced endometriosis undergoing surgery in the pediatric ward of Rasoul Akram Hospital. After surgery, the patients will be divided into three groups: treatment with dienogest and contraceptive pill (LD) and also a control group. Quality of life and VAS questionnaires will be used before and in two stages of post-test and follow-up, 3 and 6 months after surgery, respectively, and then will compare between the three groups.
Patients with advanced endometriosis undergoing surgery in the pediatric ward of Rasoul Akram Hospital. After surgery, the patients will be divided into three groups: treatment with dienogest and contraceptive pill (LD) and also a control group. Quality of life (WHOQOL-BREF), VAS, and three-point score questionnaires will be used before and in two stages of post-test and follow-up, 3 and 6 months after surgery, respectively, and then will compare between the three groups.
Patients with advanced endometriosis undergoing surgery in the pediatric ward of Rasoul Akram Hospital. After surgery, the patients will be divided into three groups: treatment with dienogest and contraceptive pill (LD) and also a control group. Quality of life (WHOQOL-BREF), VAS, and VASthree-point score questionnaires will be used before and in two stages of post-test and follow-up, 3 and 6 months after surgery, respectively, and then will compare between the three groups.
دربیماران مبتلا به آندومتریوز پیشرفته جراحی شده در بخش زنان بیمارستان رسول اکرم. بيماران پس از جراحي در سه گروه درمان با داينوجست و قرص جلوگيري از بارداري (LD) و گروه کنترل قرار خواهند گرفت. پرسشنامه ي کيفيت زندگي و پرسشنامه ي (VAS) پيش از جراحي و در دو مرحله پس آزمون و پيگيري به ترتيب سه و شش ماه پس از جراحي استفاده خواهد گرديد و سپس بر اساس نمرات بدست آمده بين سه گروه مقايسه انجام خواهد شد.
در بیماران مبتلا به آندومتریوز پیشرفته جراحی شده در بخش زنان بیمارستان رسول اکرم. بيماران پس از جراحي در سه گروه درمان با داينوجست و قرص جلوگيري از بارداري (LD) و گروه کنترل قرار خواهند گرفت. پرسشنامه ي کيفيت زندگي (فرم کوتاه پرسشنامه کیفیت زندگی سازمان بهداشت جهانی)، پرسشنامه ي (VAS) و پرسشنامه سه پاسخی (بلی، خیر، تا حدی) پيش از جراحي و در دو مرحله پس آزمون و پيگيري به ترتيب سه و شش ماه پس از جراحي استفاده خواهد گرديد و سپس بر اساس نمرات بدست آمده بين سه گروه مقايسه انجام خواهد شد.
دربیماراندر بیماران مبتلا به آندومتریوز پیشرفته جراحی شده در بخش زنان بیمارستان رسول اکرم. بيماران پس از جراحي در سه گروه درمان با داينوجست و قرص جلوگيري از بارداري (LD) و گروه کنترل قرار خواهند گرفت. پرسشنامه ي کيفيت زندگي و(فرم کوتاه پرسشنامه کیفیت زندگی سازمان بهداشت جهانی)، پرسشنامه ي (VAS) و پرسشنامه سه پاسخی (بلی، خیر، تا حدی) پيش از جراحي و در دو مرحله پس آزمون و پيگيري به ترتيب سه و شش ماه پس از جراحي استفاده خواهد گرديد و سپس بر اساس نمرات بدست آمده بين سه گروه مقايسه انجام خواهد شد.
This study was performed before and after the surgical procedure in three groups of patients with advanced endometriosis who received dienogest and contraceptive pills and also a placebo for the control group after surgery and compared.
This study was performed before and after the surgical procedure in three groups of patients with advanced endometriosis who received dienogest (2 mg) and contraceptive pills (LD) and also a placebo for the control group after surgery and compared.
This study was performed before and after the surgical procedure in three groups of patients with advanced endometriosis who received dienogest (2 mg) and contraceptive pills (LD) and also a placebo for the control group after surgery and compared.
گروه مداخله یک:داروی داینوجست
گروه مداخله دو:قرصهای پیشگیری از بارداری
گروه کنترل پلاسبو
گروه مداخله یک: 2 میلی گرم داینوجست
گروه مداخله دو: قرصهای پیشگیری از بارداری (ال دی)
گروه کنترل: پلاسبو
گروه مداخله یک:داروی 2 میلی گرم داینوجست گروه مداخله دو:قرصهای پیشگیری از بارداری (ال دی) گروه کنترل: پلاسبو
dysmenorrhea and quality of life in advanced endometriosis in surgery patients
Pain and quality of life in advanced endometriosis in surgery patients
dysmenorrheaPain and quality of life in advanced endometriosis in surgery patients
دیسمنوره و کیفیت زندگی در بیماران آندومتریوز پیشرفته جراحي شده
درد و کیفیت زندگی در بیماران آندومتریوز پیشرفته جراحي شده
دیسمنورهدرد و کیفیت زندگی در بیماران آندومتریوز پیشرفته جراحي شده
General information
empty
18
18
empty
Year
year
Yes
No
1
empty
45
45
empty
Year
year
Yes
No
1
74
108
74108
74
108
74108
The comparison of treatment with dienogest and contraceptive oral pills on the improvement of Dysmenorrhea, and quality of life in surgery patients with advanced endometriosis
The comparison of treatment with dienogest and contraceptive oral pills on the improvement of pain, and quality of life in surgery patients with advanced endometriosis
The comparison of treatment with dienogest and contraceptive oral pills on the improvement of Dysmenorrheapain, and quality of life in surgery patients with advanced endometriosis
مقایسه اثر درمان داینوجست و قرص جلوگیری از بارداری بر دیسمنوره وکیفیت زندگی دربیماران مبتلا به آندومتریوز پیشرفته جراحی شده
مقایسه اثر درمان داینوجست و قرص جلوگیری از بارداری بر درد وکیفیت زندگی در بیماران مبتلا به آندومتریوز پیشرفته جراحی شده
مقایسه اثر درمان داینوجست و قرص جلوگیری از بارداری بر دیسمنورهدرد وکیفیت زندگی دربیماراندر بیماران مبتلا به آندومتریوز پیشرفته جراحی شده
The comparison of treatment with dienogest and contraceptive oral pills on the improvement of Dysmenorrhea, and quality of life in surgery patients with advanced endometriosis
The comparison of treatment with dienogest and contraceptive oral pills on the improvement of pain, and quality of life in surgery patients with advanced endometriosis
The comparison of treatment with dienogest and contraceptive oral pills on the improvement of Dysmenorrheapain, and quality of life in surgery patients with advanced endometriosis
مقایسه اثر درمان داینوجست و قرص جلوگیری از بارداری بر دیسمنوره وکیفیت زندگی، دربیماران مبتلا به آندومتریوز پیشرفته جراحی شده
مقایسه اثر درمان داینوجست و قرص جلوگیری از بارداری بر درد وکیفیت زندگی در بیماران مبتلا به آندومتریوز پیشرفته جراحی شده
مقایسه اثر درمان داینوجست و قرص جلوگیری از بارداری بر دیسمنورهدرد وکیفیت زندگی، دربیماران در بیماران مبتلا به آندومتریوز پیشرفته جراحی شده
Early diagnosis of endometriosis and chronic pelvic pain associated with endometriosis
patients with advanced endometriosis who underwent surgery
Early diagnosis of endometriosis and chronic pelvic pain associated with endometriosis
Patients with advanced endometriosis who underwent surgery
Age 18 - 45 years
Body mass index (BMI) 18.5 – 29.9 kg/m2;
No gynecological malignancy
No contraindications to OCP or dienogest
No plans of pregnancy in the near
No underlying diseases
Early diagnosis of endometriosis and chronic pelvic pain associated with endometriosis patientsPatients with advanced endometriosis who underwent surgery Age 18 - 45 years Body mass index (BMI) 18.5 – 29.9 kg/m2; No gynecological malignancy No contraindications to OCP or dienogest No plans of pregnancy in the near No underlying diseases
تشخیص اولیه اندومتریوز و درد لگنی مزمن مرتبط با اندومتریوزیس
بیماران مطالعه افراد مبتلا به آندومتریوز پیشرفته هستند که تحت عمل جراحي قرار گرفته اند
تشخیص اولیه اندومتریوز و درد لگنی مزمن مرتبط با اندومتریوزیس
بیماران مطالعه افراد مبتلا به آندومتریوز پیشرفته هستند که تحت عمل جراحي قرار گرفته اند
سن 18 تا 45 سال
شاخص توده بدنی 18.5 تا 29.9 کیلوگرم/مترمربع
فقدان بدخیمی ژنیکولوژیک
عدم وجود منع مصرف داینوژست و قرصهای پیشگیری از بارداری
فقدان برنامه برای بارداری در آینده ی نزدیک
فقدان بیماری زمینه ایی
تشخیص اولیه اندومتریوز و درد لگنی مزمن مرتبط با اندومتریوزیس بیماران مطالعه افراد مبتلا به آندومتریوز پیشرفته هستند که تحت عمل جراحي قرار گرفته اند سن 18 تا 45 سال شاخص توده بدنی 18.5 تا 29.9 کیلوگرم/مترمربع فقدان بدخیمی ژنیکولوژیک عدم وجود منع مصرف داینوژست و قرصهای پیشگیری از بارداری فقدان برنامه برای بارداری در آینده ی نزدیک فقدان بیماری زمینه ایی
Primary outcomes
#1
pain
Pain
painPain
Pre-test a day before surgery - Post-test 3 months after surgery - Follow-up 6 months after surgery
Before surgery, 3 and 6 months after surgery
Pre-test a day beforeBefore surgery - Post-test, 3 months after surgery - Follow-upand 6 months after surgery
پيش آزمون يک روز پيش از جراحي- پس آزمون 3 ماه پس از جراحي و پيگيري 6 ماه پس از جراحي
پيش آزمون يک روز پيش از جراحي- 3 و 6 ماه پس از جراحي
پيش آزمون يک روز پيش از جراحي- پس آزمون 3 ماه پس از جراحي و پيگيري 6 ماه پس از جراحي
Patients are evaluated for visual symptoms (dysmenorrhea, dyspareunia, pelvic pain, and dysuria) using the Visual Analogue Scale (VAS).
Pelvic pain and dyspareunia scores are evaluated using the Visual Analogue Scale (VAS) and dysuria and dyschezia using a three-point score questionnire by possible answers to the items were “yes”, “no”, and “a little”.
PatientsPelvic pain and dyspareunia scores are evaluated for visual symptoms (dysmenorrhea, dyspareunia, pelvic pain, and dysuria) using the Visual Analogue Scale (VAS) and dysuria and dyschezia using a three-point score questionnire by possible answers to the items were “yes”, “no”, and “a little”.
بیماران از نظر علایم درد (دیسمنوره، دیسپارونی، درد لگنی و دیزوری) به وسیله Visual Analogue Scale (VAS)بررسی می شوند
درد لگن و دیس پارونی به وسیله Visual Analogue Scale (VAS) و دیزوری و دیسچزیا با یک پرسشنامه سه پاسخی (بلی، خیر، تا حدی) بررسی می شوند
بیماران از نظر علایم درد (دیسمنوره، دیسپارونی، درد لگنیلگن و دیزوری)دیس پارونی به وسیله Visual Analogue Scale (VAS)بررسیVAS) و دیزوری و دیسچزیا با یک پرسشنامه سه پاسخی (بلی، خیر، تا حدی) بررسی می شوند
#2
Quality of life
empty
Quality of life
کيفيت زندگي
empty
کيفيت زندگي
Pre-test a day before surgery - Post-test 3 months after surgery - Follow-up 6 months after surgery
empty
Pre-test a day before surgery - Post-test 3 months after surgery - Follow-up 6 months after surgery
پيش آزمون يک روز پيش از جراحي- پس آزمون 3 ماه پس از جراحي و پيگيري 6 ماه پس از جراحي
empty
پيش آزمون يک روز پيش از جراحي- پس آزمون 3 ماه پس از جراحي و پيگيري 6 ماه پس از جراحي
A QOL questionnaire is used to assess the quality of life.
empty
A QOL questionnaire is used to assess the quality of life.
جهت ارزیابی کیفیت زندگی پرسشنامه ي (QOL) استفاده می شود.
empty
جهت ارزیابی کیفیت زندگی پرسشنامه ي (QOL) استفاده می شود.
Secondary outcomes
#1
empty
Quality of life
Quality of life
empty
کيفيت زندگي
کيفيت زندگي
empty
Before surgery, 3 and 6 months after surgery
Before surgery, 3 and 6 months after surgery
empty
پيش آزمون، 3 و 6 ماه پس از جراحي
پيش آزمون، 3 و 6 ماه پس از جراحي
empty
Quality of life was measured using WHOQOL-BREF
Quality of life was measured using WHOQOL-BREF
empty
جهت ارزیابی کیفیت زندگی پرسشنامه کیفیت زندگی سازمان بهداشت جهانی – فرم کوتاه استفاده می شود.
جهت ارزیابی کیفیت زندگی پرسشنامه کیفیت زندگی سازمان بهداشت جهانی – فرم کوتاه استفاده می شود.
#2
empty
Edverse effects of the treatment
Edverse effects of the treatment
empty
عوارض جانبی درمان
عوارض جانبی درمان
empty
3 and 6 months after surgery
3 and 6 months after surgery
empty
3 و 6 ماه پس از جراحی
3 و 6 ماه پس از جراحی
empty
Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
#3
empty
Pain recurrence
Pain recurrence
empty
عود درد
عود درد
empty
6 months after surgery
6 months after surgery
empty
6 ماه پس از جراحی
6 ماه پس از جراحی
empty
Questionnaire
Questionnaire
empty
پرسشنامه
پرسشنامه
Protocol summary
Study aim
The comparison of treatment with dienogest and contraceptive oral pills on the pain and quality of life in surgery patients with advanced endometriosis
Design
This study will perform before and after the surgical procedure in three groups of patients with advanced endometriosis who will receive dienogest and contraceptive pills after surgery. Participants will be randomly assigned to three groups (two intervention groups and a control group). Sample size will be calculated and applied using the sample size calculation formula
Settings and conduct
Patients with advanced endometriosis undergoing surgery in the pediatric ward of Rasoul Akram Hospital. After surgery, the patients will be divided into three groups: treatment with dienogest and contraceptive pill (LD) and also a control group. Quality of life (WHOQOL-BREF), VAS, and three-point score questionnaires will be used before and in two stages of post-test and follow-up, 3 and 6 months after surgery, respectively, and then will compare between the three groups.
Participants/Inclusion and exclusion criteria
Initial diagnosis of endometriosis and chronic pelvic pain associated with endometriosis in surgery patients, informed consent to study, no pelvic pain originating from other organs
Intervention groups
This study was performed before and after the surgical procedure in three groups of patients with advanced endometriosis who received dienogest (2 mg) and contraceptive pills (LD) and also a placebo for the control group after surgery and compared.
Main outcome variables
Pain and quality of life in advanced endometriosis in surgery patients
General information
Reason for update
Add a control group to study and conduct experiments with three groups
Correction of the realized time of the beginning and end of the trial
Acronym
IRCT registration information
IRCT registration number:IRCT20191011045063N1
Registration date:2020-02-20, 1398/12/01
Registration timing:registered_while_recruiting
Last update:2022-02-25, 1400/12/06
Update count:4
Registration date
2020-02-20, 1398/12/01
Registrant information
Name
Gelareh Niakan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8807 1886
Email address
g.niakan59@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
2018-03-27, 1397/01/07
Actual recruitment end date
2020-03-05, 1398/12/15
Trial completion date
2020-03-29, 1399/01/10
Scientific title
The comparison of treatment with dienogest and contraceptive oral pills on the improvement of pain, and quality of life in surgery patients with advanced endometriosis
Public title
The comparison of treatment with dienogest and contraceptive oral pills on the improvement of pain, and quality of life in surgery patients with advanced endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Early diagnosis of endometriosis and chronic pelvic pain associated with endometriosis
Patients with advanced endometriosis who underwent surgery
Age 18 - 45 years
Body mass index (BMI) 18.5 – 29.9 kg/m2;
No gynecological malignancy
No contraindications to OCP or dienogest
No plans of pregnancy in the near
No underlying diseases
Exclusion criteria:
Personal dissatisfaction for inclusion in the study
Patients whose pelvic pain originates from other organs
Use of gonadotropins or other hormones three months before surgery
Age
From 18 years old to 45 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
108
Actual sample size reached:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple random method to assign participants to three groups.
Eligible individuals will be randomly divided into three groups using Excel software and RANDBETWEEN command.
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
Ethics committee of Iran University of Medical Sciences
Street address
shahrake gharb
City
Tehran
Province
Tehran
Postal code
1467864184
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.IUMS.FMD..REC.1398.128
Health conditions studied
1
Description of health condition studied
Advanced endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Pain
Timepoint
Before surgery, 3 and 6 months after surgery
Method of measurement
Pelvic pain and dyspareunia scores are evaluated using the Visual Analogue Scale (VAS) and dysuria and dyschezia using a three-point score questionnire by possible answers to the items were “yes”, “no”, and “a little”.
Secondary outcomes
1
Description
Quality of life
Timepoint
Before surgery, 3 and 6 months after surgery
Method of measurement
Quality of life was measured using WHOQOL-BREF
2
Description
Edverse effects of the treatment
Timepoint
3 and 6 months after surgery
Method of measurement
Questionnaire
3
Description
Pain recurrence
Timepoint
6 months after surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: The first group will receive the dienogest drug. Dosage of one tablet of 2 mg daily for six months
Category
Treatment - Drugs
2
Description
Intervention group: The second group will receive contraceptive pills. One tablet daily for six months
Category
Treatment - Drugs
3
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Gelareh Niakan
Street address
No. 7, Falamak shomali Ave.,shahrake gharb
City
Tehran
Province
Tehran
Postal code
1467864184
Phone
+98 21 8807 1886
Email
g.niakan59@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gelareh Niakan
Street address
Shahrake gharb
City
Tehran
Province
Tehran
Postal code
1467864184
Phone
+98 21 8807 1886
Email
g.niakan59@gmail.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
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gelareh Niakan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shahrak gharb
City
Tehran
Province
Tehran
Postal code
147864184
Phone
+98 21 8807 1886
Email
g.niakan59@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Mehdizadeh
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shahrak gharb
City
Tehran
Province
Tehran
Postal code
1467864184
Phone
+98 21 8807 1886
Email
g.niakan59@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gelareh Niakan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shahrak gharb
City
tehran
Province
Tehran
Postal code
1467864184
Phone
+98 21 8807 1886
Email
g.niakan59@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD