The effectiveness of the combined drug-surgical technique in endometriosis treatment.
Design
The randomized controlled trial, parallel-group that blockade by a randomized third-party surgeon, were randomly selected and the sample size was 20 patients.
Settings and conduct
Thirty patients who referred to Sarem hospital after diagnostic laparoscopy and endometrial staging were divided into two groups randomly. In the control group, patients will be completely removed by laparoscopic surgery. In the intervention group, 3 months of drug treatment followed by laparoscopy, remnants of the lesions are removed. Data collection and analysis are done by the statistician who does not know the type of division into intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Laparoscopy with the initial diagnosis and confirmation of endometriosis stages and informed consent form for inclusion
Exclusion criteria: People with confirmed severe adenomyosis with advanced endometriosis, People with endometrial lesions on the pelvic nerves, People who have previously undergone endometrial surgery and People who have recently received GnRH agonist.
Intervention groups
Intervention group: Endometriosis patients who will receive 3 months of drug treatment with GnRHa. After laparoscopy, remnants of the lesions are removed and medication can be continued for another three months if there are many lesions.
Main outcome variables
Pelvic pain, periodontal pain, relapse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190714044201N2
Registration date:2019-12-01, 1398/09/10
Registration timing:retrospective
Last update:2019-12-01, 1398/09/10
Update count:0
Registration date
2019-12-01, 1398/09/10
Registrant information
Name
AboTaleb Saremi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4467 0666
Email address
dr.saremi@sarem.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
2017-12-21, 1396/09/30
Actual recruitment end date
2019-02-19, 1397/11/30
Trial completion date
2020-02-20, 1398/12/01
Scientific title
Comparison of the efficacy of combined drug-surgical technique with radical surgery in the management of endometriosis treatment
Public title
Combined drug-surgical technique for the treatment of endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laparoscopy with the initial diagnosis and confirmation of endometriosis stages
Informed consent form for inclusion
Exclusion criteria:
People with confirmed severe adenomyosis with advanced endometriosis
People with endometrial lesions on the pelvic nerves
People who have previously undergone endometrial surgery.
People who have recently (less than 6 months) received GnRH agonist.
Age
From 30 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through block randomization. Patient assignment to each of the intervention and control groups was performed randomly by blocking the third surgeon using a random number table to finally equal sample size in both groups.
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
Iran University of Medical Sciences,next to Milad Tower ,Hemat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-12-15, 1396/09/24
Ethics committee reference number
IR.IUMS.REC.1396. 23099608823
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Pelvic pain
Timepoint
Before the intervention and six months after the intervention
Method of measurement
Vaginal analogous scale
2
Description
Pain during menstruation
Timepoint
Before the intervention and six months after the intervention
Method of measurement
Vaginal analogous scale
Secondary outcomes
1
Description
Recurrence of Endometriosis
Timepoint
Six months and one year after the intervention
Method of measurement
Clinical assessment
Intervention groups
1
Description
Intervention group: Endometriosis patients who used GnRh agonists for three months then underwent laparoscopic surgery.
Category
Treatment - Surgery
2
Description
Control group: Endometriosis patients who undergo laparoscopic surgery are completely removed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarem women hospital
Full name of responsible person
Dr. AboTaleb Saremi
Street address
Sarem hospital, End of Phase 3, Ekbatan Town
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4702 2288
Email
dr.mahmoodinia@sarem.org
Web page address
http://saremhospital.org/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sarem Fertility and Infertility Research Center
Full name of responsible person
AboTaleb Saremi
Street address
Ekbatan Town, End of Phase 3, Sarem Hospital
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0883
Email
mahmoodi.scrc@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sarem Fertility and Infertility Research Center
Proportion provided by this source
100
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
Sarem Infertility Fertility Research Center
Full name of responsible person
Dr. Mahbube Rasekhi Kumle
Position
Specialist physician
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ekbatan Town, End of Phase 3, Tehran
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0883
Email
majid.rasekhi@sa.gov.au
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hôpital Lariboisière
Full name of responsible person
Dr. Afshin Fazel
Position
Specialist physician
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hôpital Lariboisière 2 Rue Ambroise Paré
City
Paris
Province
Paris
Postal code
75010
Phone
+33 1 40 05 45 45
Email
mahmoodi.scrc@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sarem Fertility and Infertility Research Center(SAFIR)
Full name of responsible person
Dr. Maryam Mahmmodinia Maymand
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Genetics
Street address
Ekbatan Town, End of Phase 3, Tehran
City
Tehran
Province
Tehran
Postal code
13955144
Phone
+98 21 4467 0883
Email
mahmoodi.scrc@gmail.com
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 on the main outcomes of the study is available for sharing.
When the data will become available and for how long
The beginning of the access period is 6 months after the publication of the results of the study.
To whom data/document is available
Official assessors of the research field of the Iran University of Medical Sciences (IUMS)
Under which criteria data/document could be used
To verify the accuracy of the analysis of the study - Modeling for future studies - Use for future meta analyzes.
From where data/document is obtainable
Sarem Fertility and Infertility Research Center (SAFIR)
What processes are involved for a request to access data/document
The official application to "Iran University of Medicalscience (IUMS)" will be communicated to the "Sarem Fertility and Infertility Research Center (SAFIR)" after being approved by the competent authorities. After receiving the request, SAFIR will contact the applicant within 10 days to answer the questions.