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CTRI Number  CTRI/2023/09/057537 [Registered on: 13/09/2023] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Awareness about breast reconstruction surgery  
Scientific Title of Study   Assessing the Awareness and Perception towards breast reconstruction in breast cancer patients planned for mastectomy- a cross-sectional study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  FARHANUL HUDA 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Surgery AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9997533211  
Fax    
Email  farhanul1973huda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  FARHANUL HUDA 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Surgery AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9997533211  
Fax    
Email  farhanul1973huda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  FARHANUL HUDA 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Surgery AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9997533211  
Fax    
Email  farhanul1973huda@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Rishikesh 
 
Primary Sponsor  
Name  Farhanul Huda 
Address  Department of Surgery AIIMS Rishikesh 
Type of Sponsor  Research institution and hospital 
 
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 Farhanul Huda  AIIMS Rishikesh  Department of Surgery AIIMS Rishikesh
Dehradun
UTTARANCHAL 
9997533211

farhanul1973huda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Rishikesh  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Females more than 18 years of age diagnosed with Stage I to III BC (AJCC staging, 8th edition) and planned for MRM.
Females giving consent to participate in the study.
 
 
ExclusionCriteria 
Details  1.Male patients with BC
2.Females with Stage IV ((AJCC staging, 8th edition) BC
3.Females with other concomitant cancers
4.Females with Recurrent or Bilateral cancers
5.Females with a history of psychiatric disease not related to their present diagnosis
6.Females who cannot read or speak English or Hindi (The local language)
7.Females who have already undergone BR before
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Awareness about breast reconstruction surgery  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
reasons for refusing or accepting breast reconstruction surgery  single time point 
 
Target Sample Size   Total Sample Size="148"
Sample Size from India="148" 
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)   20/09/2023 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Breast cancer is the most common cancer affecting women. Mastectomy is still the most common surgery performed for the treatment of breast cancer. Breast reconstruction refers to the surgical restoration of the breast following mastectomy. Reconstruction has a positive impact on breast cancer survivors in terms of increasing/restoring their self-esteem, confidence, body image, and social acceptance. Despite these advantages, the rate of breast reconstruction varies widely and is poor in developing countries as compared to the developed world. There is very little literature looking into the awareness and perspectives regarding breast reconstruction in patients afflicted with breast cancer. At a time when oncoplasty is gaining popularity, we need to get rid of the misconceptions associated with breast reconstruction and increase its awareness. The current study is planned to assess the level of awareness about breast reconstruction and to understand its perception among females with breast cancer. It is a cross-sectional study that will be conducted over a period of 12 months on patients with breast cancer scheduled for mastectomy. The eligible participants will be interviewed face-to-face by asking them questions from a questionnaire, adapted from published literature on this topic. This study will help us generate evidence regarding awareness about breast reconstruction, the reasons for the choices, and myths surrounding breast reconstruction. 

 
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