| CTRI Number |
CTRI/2025/03/081593 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Audit on Hysterectomy to improve women healthcare in India |
|
Scientific Title of Study
|
Clinical Audit of hysterectomies: A Valuable tool to improve quality care at rural tertiary care Centre of Southern India |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Rathod |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Bibinagar |
| Address |
Junior Resident, Department of OBGY, Room No 20,All India Institute of medical sciences Bibinagar Hyderabad Metropolitan Region Bhuvangiri District Telangana State
Villa 21,Sparkle Inara Aushapur village, Ghatkesar, Bhuvangiri District Telangana State
Hyderabad
TELANGANA
501301
India |
| Phone |
9611288482 |
| Fax |
|
| Email |
poojaratho96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naina Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences BIBINAGAR |
| Address |
Room no 20,Department of OBGY,All India Institute of Medical Sciences Bibinagar Hyderabad Metropolitan Region Bhuvangiri District Telangana State
Emerald Park Anojjiguda, Hyderabad 500088 Telangana State
Hyderabad
TELANGANA
501301
India |
| Phone |
9552515600 |
| Fax |
|
| Email |
drnainakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Rathod |
| Designation |
Junior Resident |
| Affiliation |
AIl India Institute of Medical Sciences BIBINAGAR |
| Address |
Room No 20,Department of OBGY, All India Institute of Medical Sciences Bibinagar, Hyderabad Metropolitan Region Bhuvangiri District Telangana State
Villa 21,Sparkle Inara Aushapur village, Ghatkesar Mandal Bhuvangiri District Telangana State
Hyderabad
TELANGANA
501301
India |
| Phone |
9611288482 |
| Fax |
|
| Email |
poojaratho96@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Bibinagar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bibinagar |
| Address |
AIIMS Bibinagar,(Hyderabad Metropolitan Region) District-Yadadari Bhuvanagiri, Telangana-508126.Email:info.aiimsbibinagar@gmail.com |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pooja Rathod |
All India Institute of Medical Sciences Bibinagar |
Room No-20,Department of OBGY
Hyderabad
TELANGANA |
9611288482
poojaratho96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N993||Prolapse of vaginal vault after hysterectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
All women undergoing hysterectomy for any reason at AIIMS Bibinagar, women who have undergone hysterectomy outside and have presented to the outpatient department of Obstetrics and gynecology for other associated complaints (backache, pelvic pain, mood changes, depression, fatiguability, weight gain, post-hysterectomy bleeding from vagina, ovarian cysts, hydrosalpinx or vault/pelvic organ prolapse) will be enrolled as the study participants. |
|
| ExclusionCriteria |
| Details |
Women currently on medical management for gynecological conditions, those operated outside with incomplete information, and those refusing to participate will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To determine the pattern of hysterectomy based on their causes and histopathological findings.3. To access the % of women with medical or conservative treatment taken prior to hysterectomy and its association with the need for hysterectomy |
3months,6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To describe the % of women with immediate intraoperative, postoperative & long-term complications of hysterectomy on women health among the women undergoing hysterectomy in Yadadri district in last one year. |
3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
15/07/2027 |
| 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="0"
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
|
To the best of our knowledge, AIIMS, Bibinagar will be the first rural tertiary care institute in Telangana to start audit of hysterectomies as a part of program initiated by the government of India. . It will also provide information regarding history of any prior medical management for the cause, place of hysterectomy (private/public hospital), details and qualification of surgeon, route and indication of hysterectomy, histopathological report of the specimen, immediate complications and long-standing impacts of these surgeries on women’s health on follow-up. The data thus collected can be submitted to State Hysterectomy Monitoring Committee if asked. It will also help in formulating institutional policies to reduce the overall rate of hysterectomy and its associated morbidities in this part of country. |