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临床试验/CTRI/2025/09/094486
CTRI/2025/09/094486尚未招募不适用

Iron Deficiency Anemia in Cancer Patients Undergoing Surgery and its Impact on Quality of Life and Post Operative Complications– An Observational Analytical Study

Jawaharlal institute of postgraduate medical education and research1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
384
试验地点
1
主要终点
To evaluate the prevalence of iron deficiency anemia among cancer patients who undergo surgery using serum iron studies

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients in the age group of 18 to 70 years of age with cancer undergoing elective cancer surgery.

排除标准

  • Non-iron Deficiency Anemia like Anemic patients with other etiologies (examples like hemolytic anemia, vitamin B12 or folate deficiency, bone marrow disease).
  • 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.

结局指标

主要结局

To evaluate the prevalence of iron deficiency anemia among cancer patients who undergo surgery using serum iron studies

时间窗: 1.Pre operative day | 2.Post operatively till the day of discharge

次要结局

  • To establish whether there is an association between preoperative iron deficiency anemia and(1. QoL preoperatively using FACT-An ques-tionnaire)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dhanavath Sanjay Naik

Jawaharlal institute of postgraduate medical education and research

研究点 (1)

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