Feasibility of conducting a randomized controlled trial to explore the muscular influence of post‐operative intravenous iron treatment for anaemia after major abdominal surgery

TL;DR

A pilot study found it was not feasible to recruit enough patients to test if iron treatment improves recovery and muscle function after major abdominal surgery.

Contribution

This study evaluates the feasibility of a novel RCT design to assess post-operative iron therapy's impact on muscle recovery.

Findings

Only four patients were recruited out of 205 screened, making the trial infeasible.

The single participant who completed the trial showed a trend toward improved quality of life and muscle function.

Recruitment challenges suggest difficulties in implementing similar trials for post-operative iron therapy.

Abstract

Iron deficiency anaemia is common in patients recovering from major surgery and is associated with poorer post‐operative outcomes. We designed a randomized controlled trial treating post‐operative anaemia with iron therapy to observe the influence on post‐operative recovery.

Anaemic patients (haemoglobin [Hb] < 120 g/L for women, Hb < 130 g/L for men) recovering from major abdominal surgery at Fiona Stanley Hospital were recruited. Patients were double‐blind randomized 1:1 to ferric carboxymaltose (FCM) or saline administered 4 weeks post‐discharge and included in a 12‐week exercise programme. Iron indices, quality of life (QoL) questionnaires and muscle function tests were conducted at 4 weeks (baseline), 8‐, 12‐ and 16‐weeks post‐discharge. This pilot study primarily aimed to assess the feasibility of recruiting 20 patients per intervention arm. Trial registration: ACTRN12622001447741.

Of 205 eligible patients screened between 5 May 2023 and 31 August 2023, only four patients were recruited, of which one completed the study. After randomization to FCM, results obtained from the sole participant that completed the trial suggested a trend towards improvement in QoL outcomes, Hb and muscle function.

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

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