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CTRI Number  CTRI/2026/01/100357 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 04/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Incidence of Lymphedema after Modified Radical Mastectomy 
Scientific Title of Study   Incidence of Lymphedema after Modified Radical 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  Dr Tejinder Kaur 
Designation  PGJR 
Affiliation  Govt Medical College and Hospital, Sector-32, Chandigarh 
Address  Department of General Surgery Level III, D Block Government Medical College and Hospital Sector 32A Chandigarh Chandigarh CHANDIGARH 160031 India
Department of General Surgery Level III, D Block Government Medical College and Hospital Sector 32A Chandigarh Chandigarh CHANDIGARH 160031 India
Chandigarh
CHANDIGARH
160031
India 
Phone  9876220456  
Fax    
Email  jhamatpooja786@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Robin Kaushik 
Designation  Professor 
Affiliation  GMCH, Chandigarh 
Address  Department of General Surgery, Level-III, D-Block, Chandigarh

Chandigarh
CHANDIGARH
160031
India 
Phone  9646121638  
Fax    
Email  robinkaushik@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Robin Kaushik 
Designation  Professor 
Affiliation  GMCH, Chandigarh 
Address  Department of General Surgery, Level-III, D-Block, Chandigarh

Chandigarh
CHANDIGARH
160031
India 
Phone  9646121638  
Fax    
Email  robinkaushik@yahoo.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital, Sector 32, Chandigarh, 160031, INDIA 
 
Primary Sponsor  
Name  Government Medical College and Hospital Chandigarh 
Address  Department of General surgery, GMCH-32, Chandigarh, 160031, INDIA 
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 
Prof Dr Robin Kaushik  Government medical college and hospital, Chandigarh  Department of General Surgery, Level-III, D-Block, Chandigarh, 160031, INDIA
Chandigarh
CHANDIGARH 
9646121638

robinkaushik@yahoo.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: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  1. All adult female patients with breast cancer undergoing Modified Radical Mastectomy.
2. All patients consenting for the study.
 
 
ExclusionCriteria 
Details  1. Patients presenting with recurrent breast cancer.
2. Patients with contralateral breast cancer who have previously undergone Modified Radical Mastectomy/Radiation therapy.
3. Patients having undergone prior surgery for any upper limb condition.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of lymphedema in post Modified Radical Mastectomy patients  Arm volume to be measured once at the time of admission (Baseline), 10 weeks and 24 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/01/2026 
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  

Lymphedema is fluid buildup in the interstitial space due to impaired lymphatic drainage, often caused by surgery, cancer, radiation, or infection. Breast cancer-related lymphedema (BCRL) commonly affects the arm after treatments like axillary lymph node dissection (ALND) and/or radiation. A meta-analysis reported a 21.4% incidence of BCRL, though estimates range from 5% to 89% due to varying diagnostic criteria. Symptoms include arm swelling, heaviness, tightness, and discomfort. BCRL severity is classified based on excess arm volume: mild (<20%), moderate (20–40%), and severe (>40%). Despite advances in treatment, BCRL remains a concern, especially in patients undergoing both ALND and radiation. It can cause pain, reduced mobility, recurrent infections, and psychological issues. Diagnosis methods include limb circumference measurements, water displacement, MRI, bioimpedance spectroscopy, and perometry. A common approach is measuring arm circumference every 4 cm and calculating volume using the truncated cone formula. Early detection is key to managing BCRL effectively.

 
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