| CTRI Number |
CTRI/2025/12/098752 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing women with fibroids before their operation to see if they may also have endometriosis |
|
Scientific Title of Study
|
Pre operative assessment to predict associated endometriosis in women with fibroids undergoing surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIKSHA GOYAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Kasturba Medical college, MAHE, Manipal |
| Address |
ANC Scan room, third floor, Women and child block
Department of obstetrics and gynecology,
Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8427710950 |
| Fax |
|
| Email |
gdiksha5656@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHYAMALA G |
| Designation |
PROFESSOR AND HOU |
| Affiliation |
Kasturba Medical college, MAHE, Manipal |
| Address |
ANC Scan room, third floor, Women and child block
Department of obstetrics and gynecology,
Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844551037 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DIKSHA GOYAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Kasturba Medical college, MAHE, Manipal |
| Address |
ANC Scan room, third floor, Women and child block
Department of obstetrics and gynecology,
Kasturba Hospital Manipal
KARNATAKA
576104
India |
| Phone |
8427710950 |
| Fax |
|
| Email |
gdiksha5656@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital Manipal, 57610, Karnataka , India |
|
|
Primary Sponsor
|
| Name |
Diksha Goyal |
| Address |
ANC Scan room, third floor, Women and child block
Department of obstetrics and gynecology,
Kasturba Hospital Manipal |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DIKSHA GOYAL |
Kasturba Hospital Manipal |
ANC Scan room, third floor, Women and child block
Department of obstetrics and gynecology,
576104
Udupi
KARNATAKA |
8427710950
gdiksha5656@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N809||Endometriosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
women aged 18 or older, previously or newly diagnosed with uterine fibroids, undergoing myomectomy or hysterectomy |
|
| ExclusionCriteria |
| Details |
women less than 18 years of age
women who are post menopausal
women who have history of more than one course of PID treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find correlation between clinical and USG findings with per op presence of endometriosis
To evaluate the correlation between intra operative assessment of endometriotic adhesion scores (r-ASRM score) and relevant clinical or diagnostic parameters
|
baseline, 2 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
20/12/2025 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The coexistence of endometriosis and uterine fibroids presents significant diagnostic and therapeutic challenges. Advancements in imaging techniques, scoring systems, and predictive modeling offer promising avenues for enhancing preoperative assessment. A comprehensive approach that integrates clinical evaluation, advanced imaging, and intraoperative findings is crucial for the effective management of women with these concurrent gynecological conditions |