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CTRI Number  CTRI/2025/09/094486 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On: 08/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   How low iron affects healing and daily life in cancer surgery patients 
Scientific Title of Study   Iron Deficiency Anemia in Cancer Patients Undergoing Surgery and its Impact on Quality of Life and Post Operative Complications– An Observational Analytical Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhanavath Sanjay Naik 
Designation  Junior Resident 
Affiliation  Jawaharlal institute of postgraduate medical education and research 
Address  Department of Anesthesiology and critical care,2nd floor institute block, JIPMER campus, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  6302735671  
Fax    
Email  jr8859@jipmer.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priya Rudingwa 
Designation  Additional professor 
Affiliation  Jawaharlal institute of postgraduate medical education and research 
Address  Department of Anesthesiology and critical care, Ipd block 2nd floor, JIPMER.

Pondicherry
PONDICHERRY
605006
India 
Phone  8903468132  
Fax    
Email  priyaab8@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dhanavath Sanjay Naik 
Designation  Junior Resident 
Affiliation  Jawaharlal institute of postgraduate medical education and research 
Address  Department of Anesthesiology and critical care,2nd floor institute block, JIPMER campus, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  6302735671  
Fax    
Email  jr8859@jipmer.ac.in  
 
Source of Monetary or Material Support  
Jawaharlal institute of post graduate medical education and research ( Intramural fund ) pondicherry 
 
Primary Sponsor  
Name  Jawaharlal institute of postgraduate medical education and research 
Address  JIPMER campus road,Gorimedu, Dhanvantri nagar, Pondicherry 605006 
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 
Dhanavath Sanjay Naik  Jawaharlal institute of post graduate medical education and research  Department of Anesthesiology and critical care office, Second floor institute block, JIPMER, Gorimedu.
Pondicherry
PONDICHERRY 
06302735671

jr8859@jipmer.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee Jipmer  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients in the age group of 18 to 70 years of age with cancer undergoing elective cancer surgery. 
 
ExclusionCriteria 
Details  1. Non-iron Deficiency Anemia like Anemic patients with other etiologies (examples like hemolytic anemia, vitamin B12 or folate deficiency, bone marrow disease).

2. Chronic Kidney Disease (CKD) patients: CKD patients with severe to moderate renal impairment (eGFR less than 30 mL/min) with erythropoiesis effect.

3 Active Infection or Inflammatory Diseases: Sep-sis, tuberculosis, or autoimmune disease-causing anemia irrespective of iron deficiency.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the prevalence of iron deficiency anemia among cancer patients who undergo surgery using serum iron studies   1.Pre operative day
2.Post operatively till the day of discharge 
 
Secondary Outcome  
Outcome  TimePoints 
To establish whether there is an association between preoperative iron deficiency anemia and
1. QoL preoperatively using FACT-An ques-tionnaire
2. Postoperative morbidity in terms of surgical site infection rates, delayed wound healing and hospital stay
 
1.Pre operative day
2.Post operatively till the day of discharge 
 
Target Sample Size   Total Sample Size="384"
Sample Size from India="384" 
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)   01/01/2026 
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  

Patients with malignancies scheduled for elective surgery will be enrolled after providing informed written consent. Patients fulfilling the inclusion criteria will be identified during surgical assessment, and baseline data, including demographic details (age, gender, BMI, and socioeconomic status), cancer type, stage, prior treatments (radiotherapy or chemotherapy), and comorbidities, will be documented. Preoperative laboratory investigations will include a complete blood count, iron studies (serum ferritin, transferrin saturation, serum iron, and total iron-binding capacity), and renal and liver function tests to exclude secondary causes of anemia. 4ml of blood will be drawn in excess to routine investigations for research purpose. To differentiate absolute iron deficiency anemia (IDA) from functional iron deficiency due to inflammation (anemia of chronic disease), absolute IDA will be defined as serum ferritin <30 ng/mL and transferrin saturation (TSAT) <20%, while functional iron deficiency will be considered when ferritin is 30–100 ng/mL with TSAT <20%. The reports of the iron studies will be shared with the treating surgeon, and the treatment, if provided, will be recorded. A preoperative quality of life (QoL) assessment using FACT-An will be conducted.

During the perioperative period, all patients will undergo elective oncologic surgery following standardized surgical and anesthetic protocols, and intraoperative parameters such as blood loss, transfusion requirements, hemodynamic instability (requirement of continuous infusion of inotropes and/or vasopressor support in the intraoperative period), complications, and operating time will be recorded. Postoperatively, patients will be monitored for complications like surgical site infections, anastomotic leak, and acute kidney injury. Need for blood transfusion, duration of hospital stay and any readmission following discharge (within 30 days) will be recorded. QoL will be reassessed before discharge using the same validated questionnaire (Fact-An Questionnaire) to evaluate early postoperative recovery.

 
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