| 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
|
|
|
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
|
|
|
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. |