The aim of this study was to investigate the effect of endometrial resection by hysteroscopy in preventing recurrence of endometrial polyps in patients with polyps at the age of 40 and over, referred to Rasoul-e-Akram Hospital in 1396
Design
The present study is a clinical trial study that will be carried out on 94 women with polyps at the age of 40 years after applying the exclusion and Inclusion criteria.
Settings and conduct
For this research, after receiving the ethical confirmation from the Ethics Committee of Iran University of Medical Sciences, patient with endometrial polyps referring to the Department of Obstetrics and Gynecology of Rasoul Akram Hospital and those patients who are not willing to become pregnant, candidates for hysteroscopic polypectomy . Selection is done completely randomly. They are divided into two groups
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Endometrial polyps; over 40 years of age; Satisfaction to participate in the study.
Non-inclusion criteria: presence of high blood pressure or diabetes mellitus; tamoxifen consumption; presence of endometrial resection indication.
Intervention groups
Intervention: The first group include 47 patients who will receive the desired intervention, means endometrial resection. The second group won't undergo endometrial resection.
Main outcome variables
Intervention outcome: After a maximum of 3 months after surgery, patients are contacted in both groups and invited to visit and performing TVS ultrasound. The purpose of this ultrasound is to R/O permanent polyps. Then, at intervals of 6 to 12 months after surgery, the patients are contacted for evaluation early onset recurrence and invited to visit for performing TVS. If the radiologist needs another diagnostic method in relation to the probability of recurrence, then this will be done by the SIS at the discretion of the patient. Outcome Measurement Tool: Transvaginal sonography and, if necessary, SIS.
Main outcome Variable : Endometrial polyps recurrence that measured through transvaginal sonography
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150909023949N7
Registration date:2018-01-28, 1396/11/08
Registration timing:retrospective
Last update:2018-01-28, 1396/11/08
Update count:0
Registration date
2018-01-28, 1396/11/08
Registrant information
Name
Mansoureh Vahdat
Name of organization / entity
Iran University of medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
vahdat.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-10-08, 1396/07/16
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Hysteroscopic Endometrial resection on the prevention of the endometrial polyps recurrence
Public title
Effectiveness of Hysteroscopic Endometrial resection on the prevention of endometrial polyps recurrence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Endometrial polyps
over 40 years of age
Satisfaction to participate in the study
Exclusion criteria:
presence of Hypertension or diabetes
Tamoxifen consumption
dissatisfaction to participate in the study
presence of endometrial resection indication
Age
From 40 years old to 68 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random numbers table
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients, the person who evaluates the outcome of the study, and the person analyzing the data will not know the random allocation of the individuals to the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Iran University of Medical Sciences
Street address
Iran University Of Medical Sciences, next to Milad tower, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-10-07, 1396/07/15
Ethics committee reference number
IR.IUMS.REC 1396.30651
Health conditions studied
1
Description of health condition studied
Endometrial polyp
ICD-10 code
N84.0
ICD-10 code description
Polyp of corpus uteri
Primary outcomes
1
Description
recurrence of Endometrial polyp
Timepoint
6 months after histerscopy
Method of measurement
trans vaginal sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group after anesthesia, and placing the patient in the lithotomy position, hysteroscope will be introduced and uterine cavity will be observed. After cavity and ostium vision, polypectomy will be done if the polypomatose lesion is observed. Then endometrial resection will be done by resectoscope.
Category
Treatment - Surgery
2
Description
Control group: after anesthesia, and placing patient in the lithotomy position, hysteroscope will be introduced and uterine cavity will be observed. After cavity and ostium vision, polypectomy will be done if the polypomatose lesion is observed. Polypectomy will be done by scissor, grasper or resectoscope . In this group endometrial resection will not be done.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul E Akram Hospital
Full name of responsible person
Dr.Mania Kaveh
Street address
Endometriosis Research Center, Hazrat Rasool Akram Educational and Research Center, Niayesh Avenue, Sattarkhan Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Email
maniakaveh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Seeyd Kazem Malekouti
Street address
Iran University Of Medical Sciences, next to Milad tower, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
k.malekouti@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Dr. Mania Kaveh
Position
Assistant of womens Laparoscopic Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Endometriosis Research Center, Hazrat Rasool Akram Educational and Research Center, Niayesh Avenue, Sattarkhan Ave, Tehran
City
Tehran
Province
Tehran
Postal code
2562
Phone
+98 21 2562
Fax
Email
maniakaveh@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
Dr. Mansoureh Vahdat
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Endometriosis Research Center, Hazrat Rasool Akram Educational and Research Center, Niayesh Avenue, Sattarkhan Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 2562
Fax
Email
mansoureh_vahdat@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasoul Akram Hospital
Full name of responsible person
Dr. Mania Kaveh
Position
Fellowship of minimally invasive gynecologic surgery
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Endometriosis Research Center, Hazrat Rasool Akram Educational and Research Center, Niayesh Avenue, Sattarkhan Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 2562
Fax
Email
maniakaveh@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
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data except personal information
When the data will become available and for how long
After the article is published
To whom data/document is available
Obstetricians and gynecologists who are going to do more research
Under which criteria data/document could be used
further research
From where data/document is obtainable
Dr. Kaveh via email: maniakaveh@gmail.com
What processes are involved for a request to access data/document