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Evaluation of diagnostic accuracy and side effects of endometrial biopsy curette, a product of Slamtyar Hakim Engineering Company

Protocol summary

Study aim
Determining and comparing the diagnostic accuracy of endometrial sampling with endometrial biopsy catheter produced by Health Engineering Company ‌yar Hakim and dilatation and curettage
Design
In this study, 60 patients in the age range of 18-75 years who refer to endometrial tissue sampling for various reasons will be selected based on continuous sampling method and after obtaining informed consent will be examined. Due to the fact that patients are first biopsied from the endometrium by a court biopsy and then need general anesthesia, dilatation and curettage, in fact, these patients are selected as a control group to examine the endometrium with a curette, there is no need to match the age, cause of bleeding and delivery rank. These patients will be included in the study non-randomly after obtaining consent.
Settings and conduct
For sampling with a pipette, by suction of the syringe and pulling the end of the catheter tube, which has side holes, the excised tissue is inserted into the catheter. Then D&C is performed with cervical dilatation. Both samples obtained with a pipette and D&C are examined by a pathologist as a single blind.
Participants/Inclusion and exclusion criteria
The patient will be examined in the age range of 18-75 years after obtaining informed consent. Women with a history of endometrial cancer, atypical endometrial hyperplasia, a positive pregnancy test result, or unwillingness to participate are excluded from the study.
Intervention groups
Control group: Including 60 patients, dilatation and curettage operation will be performed for endometrial biopsy. Intervention group: Including 60 patients, endometrial biopsy catheter will be used for endometrial sampling, a product of Salamat yar Hakim Engineering Company.
Main outcome variables
Pathological outcome, patients' pain intensity, complications after biopsy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151120025139N2
Registration date: 2022-01-23, 1400/11/03
Registration timing: registered_while_recruiting

Last update: 2022-01-23, 1400/11/03
Update count: 0
Registration date
2022-01-23, 1400/11/03
Registrant information
Name
fariba behnamfar
Name of organization / entity
medeical school of isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 5555
Email address
behnamfar_fa@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of diagnostic accuracy and side effects of endometrial biopsy curette, a product of Slamtyar Hakim Engineering Company
Public title
Evaluation of diagnostic accuracy and side effects of endometrial biopsy curette
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 75-18 Willingness to participate in the study
Exclusion criteria:
History of endometrial cancer History of atypical endometrial hyperplasia Positive pregnancy test result Reluctance to participate
Age
From 18 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Both samples obtained by piping and D&C will be examined as a blind by a pathologist skilled in the field. A sample with a patient-specific code will be sent to the pathologist.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Third Floor, Salamat Town, Sepehr St, Shahid Aghababaei Highway,
City
Isfahan
Province
Isfehan
Postal code
8198314271
Approval date
2021-05-29, 1400/03/08
Ethics committee reference number
IR.MUI.MED.REC.1400.159

Health conditions studied

1

Description of health condition studied
Uterine endometrial biopsy
ICD-10 code
C55
ICD-10 code description
Malignant neoplasm of uterus, part unspecified

Primary outcomes

1

Description
Pathological outcome
Timepoint
10 days after biopsy
Method of measurement
Pathological evaluation

2

Description
Patients' pain intensity
Timepoint
Immediately after sampling
Method of measurement
Observation and questioning of the patient

3

Description
Complications after biopsy
Timepoint
After sampling
Method of measurement
Observe symptoms in the patient

Secondary outcomes

empty

Intervention groups

1

Description
Control group:Including 60 patients, dilatation and curettage operation will be performed for endometrial biopsy
Category
Diagnosis

2

Description
Intervention group:Including 60 patients, endometrial biopsy catheter will be used for endometrial sampling, a product of Salamat yar Hakim Engineering Company
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Shahid Beheshti Hospital
Full name of responsible person
Fatemeh Maghool
Street address
Shahid Beheshti Isfahan, Obstetrics and Gynecology Hospital, Ostad Motahhari St., Metal Bridge
City
Isfahan
Province
Isfehan
Postal code
8198314271
Phone
+98 31 3236 7001
Email
fmaghool@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Salamat yar Hakim Engineering Company
Full name of responsible person
Sayyed Emran Emami
Street address
No. 125, A01و Abu Reihan Building, University of Technology, Khomeini Shahr, Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
8415682020
Phone
+98 31 3266 7542
Email
sayyedemranemami@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Salamat yar Hakim Engineering Company
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
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Poursina Hakim Research center
Full name of responsible person
Fatemeh Maghool
Position
Research Director
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
third floor, Salat Town, Shahid Aghababaei Highway
City
Isfahan
Province
Isfehan
Postal code
8198314271
Phone
+98 31 3554 8151
Email
fmaghool@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Poursina Hakim Research center
Full name of responsible person
Fatemeh Maghool
Position
Research Director
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
third floor, Salat Town, Shahid Aghababaei Highway
City
Isfahan
Province
Isfehan
Postal code
8198314271
Phone
+98 31 3554 8151
Email
fmaghool@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Poursina Hakim Research center
Full name of responsible person
Fatemeh Maghool
Position
Research Director
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
third floor, Salat Town, Shahid Aghababaei Highway
City
Isfahan
Province
Isfehan
Postal code
8198314271
Phone
+98 31 3554 8151
Email
fmaghool@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
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