Preoperative intravenous ferric carboxymaltose versus oral ferrous ascorbate for anaemic patients undergoing elective gynecological surgery – A Randomised controlled trial Pilot Study

Background and Rationale- Preoperative anemia is an independent risk factor for postoperative morbidity, mortality, and blood transfusions. There is very high prevalence of iron deficiency anemia in India and women of reproductive age group suffering from gynecological diseases are more prone to develop the same. Rapid and timely correction of iron deficiency anemia before elective gynecological surgery may improve postoperative recovery and may have long term impact on quality of life. However previous studies have shown mixed results and well-designed randomized controlled trials on the same study population from India are lacking. Hence, we propose to perform a randomized controlled trial pilot study to compare Ferric carboxymaltose (FCM) versus oral iron for postoperative recovery among anemic women undergoing elective gynecological surgeries.

Objectives –

a.     Primary Objective

i.     To compare change of pre and postoperative blood parameters (hemoglobin and ferritin) between two groups.

b.     Secondary objectives

i.     To compare postoperative morbidity including blood transfusion requirements between two groups

ii.     Comparison of treatment related adverse effects between two groups.

iii.     Comparison of changes in the quality of life score (WHOQOL- BREF) between two groups

iv.     To assess feasibility of study design in terms of recruitment rates, implementation barriers and attrition rate

Study Methods- It will be an open level parallel group randomized controlled trial including 50 patients in each group and study will be conducted over 1 year in the department of Obstetrics and Gynecology, AIIMS Kalyani. Willing patients with hemoglobin 8-12gm/dl planned for elective gynecological surgeries will be included in this study after confirming iron deficiency anemia and ruling out the exclusion criteria. All recruited patients will be randomly allocated to ferric carboxymaltose or oral iron group. Patients in FCM group will receive injection FCM 15mg/kg in gynecology day care 4 weeks prior to elective surgery and patients in oral iron group will receive oral ferrous ascorbate 100 mg twice daily till surgery for 4 weeks. Follow-up will be done till 1 month after surgery.

Study will be registered under CTRI and any serious drug related serious adverse events will be notified to the appropriate authority as per Institute protocol.

 Study outcomes –

a.     Primary Outcomes:

i.     Change in hemoglobin (gm/dl) from baseline to day of surgery and 1 month after surgery

ii.     Change in serum ferritin (ng/ml) from baseline to 1 month after surgery

b.     Secondary Outcomes:

i.     Proportion of patients requiring perioperative red blood cell transfusion

ii.     Postoperative complications within 30 days of surgery (e.g. surgical site infections, venous thromboembolism, cardiovascular events, respiratory failure, acute kidney injury, sepsis, death)

iii.     Length of postoperative hospital stay (days)

iv.     Changes in the Quality-of-life score on WHOQOL-BREF questionnaire at recruitment and 1 month after surgery

v.     Number and severity of adverse reactions related to study medications during treatment period.

vi.     Measurement: Incidence and severity of side effects related to oral iron or FCM, such as gastrointestinal disturbances, allergic reactions and changes in serum vitamin D and phosphorus level.

vii.     Number of patients screened, eligible, enrolled, completed - to assess recruitment and retention rates