Investigating myometrial thickness and scar vascularity compared to healthy myometrium using Doppler ultrasound in patients undergoing hysteroscopic myomectomy with and without preservation of pseudocapsule.
Investigating the effect of pseudocapsule removal on myometrial thickness and scar vascularity in patients undergoing hysteroscopic myomectomy using Doppler ultrasound
Design
The clinical trial has a control group with a factorial group, double-blind, randomized on 50 patients, and random assignment software is used for randomization.
Settings and conduct
The population under study are patients undergoing hysteroscopic myomectomy in the age range of 18 to 45 years who referred to Shahid Beheshti Medical Training Center in 1402. The patients are randomly divided into two groups, preservation and removal of myoma pseudocapsule. The classification of patients is unknown
Participants/Inclusion and exclusion criteria
Inclusion criteria include the age between 18-45 years of women who have Type 1 myoma. Only one myoma and that it has an indication for surgery. The size of the myoma is less than 5 cm. The exclusion criteria for women who have more than one myoma and myoma other than type 1. They have cervicitis and are pregnant
Intervention groups
In the intervention group, the pseudocapsule myoma is removed with a resectoscope during the operation, and in the control group, the pseudocapsule is preserved.
Main outcome variables
Examination of the surgical site scar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230519058228N1
Registration date:2023-05-23, 1402/03/02
Registration timing:prospective
Last update:2023-05-23, 1402/03/02
Update count:0
Registration date
2023-05-23, 1402/03/02
Registrant information
Name
Maryam Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 7860
Email address
maryam.hashemi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating myometrial thickness and scar vascularity compared to healthy myometrium using Doppler ultrasound in patients undergoing hysteroscopic myomectomy with and without preservation of pseudocapsule.
Public title
The effect of preserving the myoma pseudocapsule wall in repairing the surgical site in patients undergoing hysteroscopic myomectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women between 18 and 45 years old who are candidates for hysteroscopic myomectomy due to a symptomatic Figo submucosal myoma.
The size of myoma should be less than 5 cm and the number of myoma should be one
Exclusion criteria:
Women who have more than one myoma and myoma other than type 1.
Women who have servicitis and are pregnant.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation software, 50 selected patients are divided into two groups: removal and preservation of myoma pseudocapsule during hysteroscopic myomectomy. In the said software, the total number of sample volume (50 people) and the number of groups (2 groups) are entered into the software. The output of the software includes a list that randomly distributes the numbers 1 to 50 in two groups. Patients are distributed in two groups according to the time of referral in the order of the mentioned list so that the sample volume reaches the required number in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is conducted in a two-way blind method. In such a way that the patients are unaware of the type of operation (preserve or removal of myoma pseudocapsule); Also, the outcome assessor (sonographer) does not know whether to preserve or remove the myoma pseudocapsule.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی اصفهان
Street address
Isfahan Hezar Jerib St. Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-05-17, 1402/02/27
Ethics committee reference number
IR.MUI.MED.REC.1402.080
Health conditions studied
1
Description of health condition studied
submucousal myoma
ICD-10 code
D25.0
ICD-10 code description
Submucous leiomyoma of uterus
Primary outcomes
1
Description
Examination of myomectomy scar
Timepoint
3 months after the operation
Method of measurement
Transvaginal ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: women with submucousal myoma Fig. 1 During the shaving of the myoma with a resectoscope, the resectoscopy is stopped as soon as the pseudocapsule is reached and the pseudocapsule is kept in place .Three months after the operation using Doppler ultrasound, scar thickness, scar vascularity And the existence of a heterogeneous mass in the operation site is checked.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Shahid Beheshti hospital
Full name of responsible person
Maryam Hashemi
Street address
Isfahan Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
maryam.hashemi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
maryam hashemi
Street address
Isfahan Hezar Jerib Street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
maryam.hashemi@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
maryam hashemi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan Hezar Jerib Street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7860
Email
maryam.hashemi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
maryam hashemi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan Hezar Jerib St., Isfahan University of Medical Sciences
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7860
Email
maryam.hashemi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
maryam hashemi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
اصفهان خیابان هزار جریب دانشگاه علوم پزشکی اصفهان
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7860
Email
maryam.hashemi@med.mui.ac.ir
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
The data will not be shared separately, but the results of their analysis will be shared in the article