| CTRI Number |
CTRI/2024/07/070832 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Other |
|
Public Title of Study
|
An interventional clinical trial to compare pipelle endometrial sampling versus hysteroscopic guided endometrial biopsy in patient with abnormal uterine bleeding . |
|
Scientific Title of Study
|
Comparison of Pipelle endometrial sampling versus Hysteroscopic guided endometrial biopsy in patients with abnormal uterine bleeding -Interventional prospective clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neelima Chelluru |
| Designation |
First year Junior resident |
| Affiliation |
All India Institute of Medical Sciences , Bathinda |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
AIIMS BATHINDA
MANDI DABWALI ROAD
PUNJAB
151001
India
Bathinda
PUNJAB
151001
India |
| Phone |
9900848052 |
| Fax |
|
| Email |
drneel1001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lajja Devi Goyal |
| Designation |
Professor and Head of Department |
| Affiliation |
AIIMS BATHINDA |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
AIIMS BATHINDA
MANDI DABWALI ROAD
Bathinda
PUNJAB
151001
India |
| Phone |
9417658846 |
| Fax |
|
| Email |
lajja.goyal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Lajja Devi Goyal |
| Designation |
Professor and Head of Department |
| Affiliation |
AIIMS BATHINDA |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
AIIMS BATHINDA
MANDI DABWALI ROAD
Bathinda
PUNJAB
151001
India |
| Phone |
9417658846 |
| Fax |
|
| Email |
lajja.goyal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES,BATHINDA
MANDI DABWALI ROAD
BATHINDA
PUNJAB
151001
INDIA
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR NEELIMA CHELLURU |
AII India Institute of medical sciences , Bathinda Bathinda , Punjab |
Department of Obstetrics and Gynaecology,
All India Institute of Medical Sciences,Bathinda
Bathinda
Punjab
Bathinda
PUNJAB |
9900848052
drneel1001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences,Bathinda Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, (2) ICD-10 Condition: N924||Excessive bleeding in the premenopausal period, (3) ICD-10 Condition: N926||Irregular menstruation, unspecified, (4) ICD-10 Condition: N950||Postmenopausal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hysteroscopic guided endometrial biopsy |
Patient with abnormal uterine bleeding will be posted for hysteroscopic guided endometrial biopsy which a gold standard procedure in diagnosing endometrial pathology, sample obtained will be given a code and sent for histopathological examination.
Duration of the procedure : 15-20 mins |
| Intervention |
Pipelle endometrial sampling |
Patient with abnormal uterine bleeding will be admitted and before getting induced under general anesthesia for hysteroscopic guided biopsy , pipelle endometrial ssampling will be done and sample will be given a code and sent for histopathological examination .
Duration of the procedure : 2-5 mins |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1.Women with more than 40 years of age with symptoms suggestive of abnormal uterine bleeding .
2.In pre-menopausal women with endometrial thickness with 7 to 12 millimeters.
3.In post-menopausal women with endometrial thickness with more than 4 millimeters.
4. In post-menopausal women with endometrial thickness less than 4 millimeters endometrial sampling will be done if -
a. If repeated bleeding after primary treatment.
b. If endometrium shows diffuse /focal increase in echogenicity.
c. If endometrium is not adequately visualized on sonography. |
|
| ExclusionCriteria |
| Details |
1. Patient on contraceptives, anticoagulants , thrombolytics or any evidence of blood dyscrasia or coagulation defects, autoimmune illness or chronic illness.
2. Patient with thrombocytopenia ( less than 100000 platelet/mm3 ).
3.Patient with active genital infection .
4.Patient with focal lesions of cervix or endometrium . |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the diagnostic accuracy of pipelle endometrial sampling versus hysteroscopic guided endometrial biopsy in patient with abnormal uterine bleeding with endometrial pathology which is based on -
1. Histopathological report obtained by the two sampling techniques |
It will be analysed based on the histopathological report obtained by the two screening techniques which will be available in 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the pipelle endometrial sampling versus hysteroscopic guided endometrial biopsy as two screening modalities in terms of
1.Comparing the associated complications in both the techniques .
2. Comparing the patient compliance in both the procedure.
3. comparing the time duration & post procedure complications. |
It will be analysed by the subjective experience of the patient regarding the compliance & post procedure complications including anesthesia related & procedural during the immediate post operative period & subsequent follow up at 1 week with histopathological report |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| Date of Study Completion (India) |
19/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Women with abnormal uterine bleeding presenting at the outpatient department of Obstetrics and Gynaecology who will meet the inclusion criteria will be enrolled in this study .
A detailed examination will be carried out including general physical examination , systemic followed by per speculum and per vaginal examination .All baseline investigations which include complete blood count , coagulation profile , thyroid function test, liver function test , renal function test , USG . After taking informed consent and explaining the patient regarding the two methods of the endometrial sampling techniques , patient will be admitted .
After getting a pre anesthesia check up done , and patient will be taken to OT on the scheduled day and sampling will be perfomed prior to anesthesia using pipelle endometrial sampling technique .In case of insufficient sample , proceudre will be repeated once or twice and sample obtained in the container will be labelled as A .
Then under general anesthesia hysteroscopic guided endometrial biopsy will be performed and sample obtained in the container will be labelled as B . Both the sample with the proper details of the patient will be sent to the pathology lab of AIIMS BATHINDA . The pathologist will be blind regardiing the sample obtained and sent for histopathological examination .
Patient will be followed up with the histopathological report and two reports obtained from the sampling technique will be further analysed to come to a fruitful conclusion in establishing the diagnostic accuracy of both the methods in abnormal uterine bleeding involving endometrial pathology . |