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CTRI Number  CTRI/2025/09/094949 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Change is quality of life after mastectomy 
Scientific Title of Study   Assessment of change in quality of life in women undergoing mastectomy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VEDIKA JHA 
Designation  Post graduate resident 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital 
Address  Lok Nayak Hospital, Jawahar Lal Nehru Marg, Near Delhi Gate, New Delhi- 110002

Central
DELHI
110002
India 
Phone  9971190368  
Fax    
Email  drvedikajha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr ANURAG MISHRA 
Designation  Professor, general surgery 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital 
Address  Lok Nayak Hospital, Jawahar Lal Nehru Marg, Near Delhi Gate, New Delhi- 110002

Central
DELHI
110002
India 
Phone  9899797734  
Fax    
Email  profanuragmamc@gmail.com  
 
Details of Contact Person
Public Query  
Name  VEDIKA JHA 
Designation  Post graduate resident 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital 
Address  Lok Nayak Hospital, Jawahar Lal Nehru Marg, Near Delhi Gate, New Delhi- 110002

Central
DELHI
110002
India 
Phone  9971190368  
Fax    
Email  drvedikajha@gmail.com  
 
Source of Monetary or Material Support  
Lok Nayak Hospital, New Delhi 
 
Primary Sponsor  
Name  Vedika Jha 
Address  Lok Nayak Hospital, Jawahar Lal Nehru Marg, Near Delhi Gate, New Delhi -110002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vedika Jha  Maulana Azad Medical college and lok nayak hospital, New Delhi- 110002  Department of Surgery, Surgery OPD, 4th floor
Central
DELHI 		 9971190368

drvedikajha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Patients planned for modified radical mastectomy 
 
ExclusionCriteria 
Details  previous psychiatric illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to assess mean change in score quality of life in women undergoing mastectomy two months post surgery  Preop and 2 months after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
to study role of following factors on QOL such as demography, stage of disease, complications like serum, wound infection, flap necrosis, pre operative counselling  On admission & 2 months after surgery  
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   20/09/2025 
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="1"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drvedikajha@gmail.com].

  6. For how long will this data be available start date provided 11-07-2025 and end date provided 11-07-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   To assess and minimise problems that affect the quality of life in patients of mastectomy  
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