| CTRI Number |
CTRI/2025/04/085467 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study on pipelle and hysteroscopy guided biopsies for postmenopausal bleeding in Thrissur
|
|
Scientific Title of Study
|
A comparison of endometrial pipelle aspiration versus hysteroscopy guided biopsy in determining etiopathology of postmenopausal bleeding in a tertiary care centre in Thrissur |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JOEL KOLANKANNI JOY |
| Designation |
Post Graduate |
| Affiliation |
AMALA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Post Graduate, Departent of OBG, Amala Institute of Medical Sciences, Amala Hospital Rd, Amala Nagar, Thrissur, Kerala
Thrissur
KERALA
680555
India |
| Phone |
9539538999 |
| Fax |
|
| Email |
Jj244998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRAMEELA MENON |
| Designation |
Professor |
| Affiliation |
AMALA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of OBG, Amala Institute of Medical Sciences, Amala Hospital Rd, Amala Nagar, Thrissur, Kerala
Thrissur
KERALA
680555
India |
| Phone |
9495568522 |
| Fax |
|
| Email |
prameelapramod@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JOEL KOLANKANNI JOY |
| Designation |
Post Graduate |
| Affiliation |
AMALA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Post Graduate, Departent of OBG, Amala Institute of Medical Sciences, Amala Hospital Rd, Amala Nagar, Thrissur, Kerala
Thrissur
KERALA
680555
India |
| Phone |
9539538999 |
| Fax |
|
| Email |
Jj244998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences Thrissur. SH69, Amalanagar, Thrissur, Kerala 680555 |
|
|
Primary Sponsor
|
| Name |
Dr Joel Kolankanni Joy |
| Address |
Post graduate, Department of obstetrics and gynaecology, Amala institute of medical sciences, Thrissur, Kerala Pin : 680555 |
| Type of Sponsor |
Other [self finance] |
|
|
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 Joel Kolankanni Joy |
Amala institute of medical sciences |
Chavara OT number 1-6,Chavara OT, Department of Obstetrics and Gynaecology
Thrissur
KERALA |
9539538999
jj24498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AMALA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N950||Postmenopausal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hysteroscopy Biopsy |
After adequate anaesthesia, patient positioned, painted and draped under aseptic precautions.Hysteroscope is inserted and hysteroscope guided biopsy taken. Sample sent for histopathology. |
| Intervention |
Pipelle aspiration |
Pipelle aspiration procedure is done before hysteroscopy.The sample collected from pipelle aspiration sent for histopathology report. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Women presenting with symptoms of postmenopausal bleeding
Ultrasonogram showing endometrial thickness ≥4mm
Women with recurrent postmenopausal bleeding irrespective of ultrasonogram
endometrial thickness
Women who are fit for hysteroscopy |
|
| ExclusionCriteria |
| Details |
Lower genital tract infections
Pelvic inflammatory disorders
Coagulation disorders
Patient who has Cervical pathology/ Vaginal pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of endometrial pipelle sampling and hysteroscope guided biopsy in determining histopathology of patients with postmenopausal bleeding. |
The histopathology results are sought 10 days after the procedure. The histopathology reports of both the procedures are compared. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hysteroscope as a better investgation of choice for postmenopausal bleeding |
The secondary outcome is obtained at time of procedure upto 10 days after procedure when histopathology results are sought. |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Even though for Abnormal
Uterine Bleeding, pipelle is found to be as effective as hysteroscopy,
there are not many studies comparing the two in postmenopausal bleeding and it
is unclear of the efficacy of pipelle endometrial sampling in detecting significant
endometrial pathologies. This study is designed to compare the outcomes of
endometrial pipelle aspiration and hysteroscopic biopsy in women presenting
with postmenopausal bleedingRESEARCH HYPOTHESIS - There
is a change in efficacy between endometrial pipelle sampling and hysteroscopy
guided biopsy in histopathological evaluation of postmenopausal bleeding. Sampling Procedure - The
procedure will be done in Operation Threatre under Anaesthesia.
Patient
will be positioned, painted and draped under aseptic precautions .
Endometrial
pipelle will be introduced into the uterus and sampling sone. The endometrial
sampling specimen will be sent for HPE. This is followed by the hysteroscopic
procedure and sample will be sent for HPE.
The
Histopathology Report of both will be compared to assess the concurrence and also
the corelation with endometrial thickness will be assessed.
|