Evaluation of the incidence of intrauterine adhesions after hysteroscopic removal of the uterine septum in a patient with metritis and its relationship with the size of the septum and the surgical method (resectoscope and scissors)
Determining the incidence and severity of uterine rupture after hysteroscopic removal of the uterine septum and determining its relationship with septal size
Design
A clinical trial with a control group, with parallel, randomized, phase 3 groups, is performed on 400 patients. Randomization is based on a table of computer random numbers.
Settings and conduct
Hysteroscopy is performed in the operating room of the gynecology ward of Imam Reza (AS) Hospital by the Olympus hysteroscope. The size of the septum (short or long) and its type (wide or narrow) are recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All women who were candidates for septum removal based on hysterosalpingography, MRI or sonohysterography with diagnosis of uterine septum, informed consent.
exclusion criteria :
not completing the consent form, having an underlying disease
Intervention groups
hysteroscopy is performed in the operating room of the women's department of Imam Reza Hospital (AS) by Olympus hysteroscope. And during that, the septum is removed with hysteroscopy scissors with a resectoscope with a monopolar L shape electrode and glycine media.
Main outcome variables
Determination of incidence and severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220420054595N1
Registration date:2022-10-01, 1401/07/09
Registration timing:registered_while_recruiting
Last update:2022-10-01, 1401/07/09
Update count:0
Registration date
2022-10-01, 1401/07/09
Registrant information
Name
Maliheh Amirian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 315 6170
Email address
amirianm1401@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the incidence of intrauterine adhesions after hysteroscopic removal of the uterine septum in a patient with metritis and its relationship with the size of the septum and the surgical method (resectoscope and scissors)
Public title
Intrauterine adhesion after removed hysteroscopic
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of uterine septum diagnosis
Patient satisfaction with entering the plan
Exclusion criteria:
Observation of another pathology intrauterine in addition to the septum, during hysteroscopy
Patient with postoperative metritis
The presence of an underlying disease that increases the risk of uterine infection.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
500
Randomization (investigator's opinion)
Randomized
Randomization description
The participants in the study are assigned to two intervention and control groups by simple randomization method, with individual units and using a table of random numbers.
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 Mashhad University of Medical Sciences
Street address
ِDepartment of Obstetrics and Gynecology, Imam Reza Hospital, Imam Reza Square.
City
Mashad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2015-10-07, 1394/07/15
Ethics committee reference number
IR.MUMS.fm.REC.1394.353
Health conditions studied
1
Description of health condition studied
Intrauterine synechiae
ICD-10 code
N85.6
ICD-10 code description
Intrauterine synechiae
Primary outcomes
1
Description
intrauterine adhesion
Timepoint
3 months after surgery
Method of measurement
checked up
2
Description
Severity of intrauterine adhesion
Timepoint
3 months after surgery
Method of measurement
Based on FIGO classification
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The septum is removed with hysteroscopic scissors with a monopolar L-shaped electrode and glycine media.
Category
Diagnosis
2
Description
Control group: The septum is removed with hysteroscopic scissors with normal saline media.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Maliheh Amirian
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital,Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
amirianm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology of Medical Sciences of Mashhad
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Shariati Square
City
Masshad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
amirianm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Golrokh Sharafati
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
golrokhsherafaty@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Golrokh Sherafati
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
amirianm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Golrokh Shariati
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
amirianm@mums.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