Operative hysteroscopy in patients with active uterine bleeding with and without uterine evacuation prior to the procedure:comaring the results
Design
This clinical trial study will be performed on 114 patients referring to the Alzahra hospital oncology clinic with abnormal uterine bleeding and in one ultrasonography, one of the diagnosis of polyp, submucosal mialis, or endometrial thickening was presented. Or they did not have an outpatient biopsy, or they were inadequate and were candidates for hysteroscopy and D & C.To divide patients into two intervention and control groups the Rand list will be used.Then the grouping numbers will be placed in the envelope These envelopes will be prepared by the person who is not involved in their preparation and issue.This person will not be responsible for any patient selection process, intervention and data analysis.
Settings and conduct
This clinical trial study will be performed on 114 patients referring to the Alzahra hospital oncology clinic with abnormal uterine bleeding.Patients will be divided into two groups of intervention and control groups.
Participants/Inclusion and exclusion criteria
Women with active hemorrhage, who are candidates for hysteroscopy, will be included in the study and will not be considered if they have coagulation disorders.
Intervention groups
In the intervention group: First, with the ring of forceps and curettes, the clots and contents of the cavity of the uterus are drained then the resectoscope enters the uterine cavity to examine the cavity and remove visible lesions and if not seen biopsy Lesion is removed under direct vision and then the curettage is done.In the control group: The resectoscope enters the uterine cavity directly and removes visible lesions and after removing the resectoscope curettage is done.
Main outcome variables
Interaoperative bleeding; Hematocrit loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005283N13
Registration date:2018-11-16, 1397/08/25
Registration timing:registered_while_recruiting
Last update:2018-11-16, 1397/08/25
Update count:0
Registration date
2018-11-16, 1397/08/25
Registrant information
Name
Manizheh Sayyah Melli
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3741
Email address
sayyahmellim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2020-09-10, 1399/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Operative hysteroscopy in patients with active uterine bleeding with and without uterine evacuation prior to the procedure:comaring the results
Public title
Operative hysteroscopy in patients with active uterine bleeding with and without uterine evacuation prior to the procedure:comaring the results
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with abnormal uterine bleeding
Diagnosis of polyps, submucosal miosis, or endometrial thickening is given in ultrasound.
Satisfaction to participate in the study
Exclusion criteria:
Dissatisfaction to participate in the study
Pregnant patients
Patients with coagulation disorders
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method will be used. So patients will be referred to the intervention and control group, respectively.
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 Tabriz University Of Medical Sciences
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166615953
Approval date
2018-10-22, 1397/07/30
Ethics committee reference number
IR.TBZMED.REC.1397.612
Health conditions studied
1
Description of health condition studied
Abnormal uterine and vaginal bleeding, unspecified
ICD-10 code
N93.9
ICD-10 code description
Abnormal uterine and vaginal bleeding, unspecified
Primary outcomes
1
Description
Interaoperative bleeding
Timepoint
At the end of surgery
Method of measurement
Visual scale
2
Description
duration of surgery
Timepoint
From the beginning to the end of surgery
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Hematocrit loss
Timepoint
6 hour after surgery
Method of measurement
blood test
Intervention groups
1
Description
In the intervention group: First, with the ring of forceps and curettes, the clots and contents of the cavity of the uterus are drained then the resectoscope enters the uterine cavity to examine the cavity and remove visible lesions and if not seen biopsy Lesion is removed under direct vision and then the curettage is done.
Category
Treatment - Surgery
2
Description
In the control group: The resectoscope enters the uterine cavity directly and removes visible lesions and after removing the resectoscope curettage is done.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Manizheh Sayyah-Melli
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3556 9543
Fax
Email
lahroudin@gmail.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,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Manizheh Sayyah-Melli
Position
prof. of Ob & Gyn
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3556 9543
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Manizheh Sayyah-Melli
Position
prof. of Ob & Gyn
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3556 9543
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Manizheh Sayyah-Melli
Position
prof. of Ob & Gyn
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available