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Comparison the accuracy and complication of D&C and endometrial biopsy in patient with abnormal uterine bleeding

Protocol summary

Summary
Objectives Endometrial biopsy has less use as first-line diagnostic method for abnormal uterine bleeding. In this study, the results of endometrial biopsy and diagnostic curettage will be compared for endometrial histopathology, adequacy obtained endometrial tissue by biopsy, complications and failure rates of these methods. First aim is evaluation of Pipelle techniques validity and accuracy for determining of endometrial histopathology in patients who present with abnormal uterine bleeding, especially for rolling out of endometrial cancer and second aim is evaluation the adequacy of obtained sample for histopathological examination, accompanying complications and the failure rate of pipelle method and comparison with diagnostic curettage technique. In this study, the failure rate is presence of any type of pathology in diagnostic curettage specimens that have not been diagnosed with pipelle. Design, Setting and conduct This is an analytical study which perform on women with abnormal uterine bleeding by sequential sampling techniques for women who will enrolled in study. All patients underwent clinical and laboratory examinations. Participants, inclusion and exclusion criteria All women older than 35 years with abnormal uterine bleeding will enroll after informed consent. All women with pregnancy; hormonal disorders including thyroid, hepatic and renal diseases, lupus, diabetes; endometrial thickness less than 4 millimeter; lower genital tract infection will exclude from study. Intervention Diagnostic intervention is endometrial biopsy which does by pipelle and diagnostic standard reference is endometrial sampling by curettage. Both techniques are performed in the operating room and at the same time. First pipelle enter to uterine cavity without cervical dilatation, then rotate and retract (pull back) for endometrial sampling. These samples are labeled “A”. Then standard diagnostic curettage will do and samples are labeled “B”. Both samples are sent for pathology that is unaware sampling method. These samples will evaluate histopathologically. Main outcome Histopathology reports for sample by pipelle and diagnostic curettage are compared and diagnostic curettage report used as the gold standard.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013081111504N4
Registration date: 2013-10-29, 1392/08/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-10-29, 1392/08/07
Registrant information
Name
Sanam Moradan
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1446 0066
Email address
smoradan@sem.ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, ُSemnan University of Medical Sciences Address: Vice chancellor for research, ُSemnan University of Medical Sciences, Central Department of Semnan University of Medical Science, Basidj Bulvard, Semnan, I.R.Iran, Tel: 00982314441420
Expected recruitment start date
2013-10-07, 1392/07/15
Expected recruitment end date
2014-03-06, 1392/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison the accuracy and complication of D&C and endometrial biopsy in patient with abnormal uterine bleeding
Public title
accuracy and complication of D&C and endometrial biopsy in patient with abnormal uterine bleeding
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Women older 35 years who have abnormal uterine bleeding. Exclusion criteria: Pregnancy; hormonal disorders including thyroid, hepatic and renal diseases, lupus, diabetes; endometrial thickness less than 4 millimeter; lower genital tract infection.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Semnan University of Medical Sicense
Street address
Central Department, Semnan University of Medical Sicense, Basidj Bulvard
City
Semnan
Postal code
Approval date
2013-08-11, 1392/05/20
Ethics committee reference number
28/20/7041

Health conditions studied

1

Description of health condition studied
Abnormal uterine bleeding
ICD-10 code
N93.9
ICD-10 code description
Abnormal uterine and vaginal bleeding, unspecified

Primary outcomes

1

Description
Accuracy of endometrial biopsy
Timepoint
After biopsy
Method of measurement
Comparison with diagnostic curettage

Secondary outcomes

empty

Intervention groups

1

Description
Diagnostic intervention is endometrial biopsy by pipelle and standard diagnostic reference is sampling by endometrial curettage. Both techniques are performed in the operating room and at the same time. First pipelle enter to uterine cavity without cervical dilatation and then rotate and retracted to get endometrial samples. These samples are labeled A. Then, standard diagnostic curettage will perform and samples are labeled B. Both samples are sent to a pathologist who is unaware from sample collection methods. The samples are evaluated and the results will compare. Diagnostic curettage report to be used as the gold standard.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al Momenin Hospital
Full name of responsible person
Masomeh Mahboob
Street address
Amir Al Momenin Hospital, Imam Hussein Square
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Semnan University of Medical Science
Full name of responsible person
Raheb Ghorbani Ph.D
Street address
Central Department of Semnan University of Medical Science, Basidj Bulvard
City
Semnan
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 of Semnan University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Masomeh Mahboob
Position
Gynecology Resident
Other areas of specialty/work
Street address
Amir Al Momenin Hospital، Imam Hussein square
City
Semnan
Postal code
Phone
+98 23 1446 0077
Fax
Email
mehrdadzahmatkesh@sem-ums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Dr. Sanam Moradan
Position
Gynecologist
Other areas of specialty/work
Street address
Amir Al Momenin Hospital, Imam Hussein Square
City
Semnan
Postal code
Phone
+98 23 1446 0077
Fax
Email
smoradan@sem-ums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research Expert
Other areas of specialty/work
Street address
Kowsar Hospital, Basidj Bulvard
City
Semnan
Postal code
Phone
+98 23 1443 7846
Fax
Email
mehrdadzahmatkesh@sem-ums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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