Feasibility of conducting a randomized controlled trial to explore the muscular influence

Background and Objectives: Iron deficiency anaemia is common in patients recover-ing from major surgery and is associated with poorer post-operative outcomes. Wedesigned a randomized controlled trial treating post-operative anaemia with irontherapy to observe the influence on post-operative recovery.

Materials and Methods: Anaemic patients (haemoglobin [Hb] < 120 g/L for women,Hb < 130 g/L for men) recovering from major abdominal surgery at Fiona StanleyHospital were recruited. Patients were double-blind randomized 1:1 to ferric carbox-ymaltose (FCM) or saline administered 4 weeks post-discharge and included in a12-week exercise programme. Iron indices, quality of life (QoL) questionnaires andmuscle function tests were conducted at 4 weeks (baseline), 8-, 12- and 16-weekspost-discharge. This pilot study primarily aimed to assess the feasibility of recruiting20 patients per intervention arm. Trial registration: ACTRN12622001447741.

Results: Of 205 eligible patients screened between 5 May 2023 and 31 August2023, only four patients were recruited, of which one completed the study. Afterrandomization to FCM, results obtained from the sole participant that completed thetrial suggested a trend towards improvement in QoL outcomes, Hb and musclefunction.

Conclusion: Recruitment to a randomized controlled trial exploring the influence ofiron therapy on muscle function after major abdominal surgery was not feasible.