A pilot randomised controlled trial of patient education to improve umbilical cleanliness prior to laparoscopic surgery

Abstract

Background: Before laparoscopic abdominal surgery, surgeons frequently remove debris from patients' umbilici to prevent it from passing into the abdomen and optimise skin antisepsis. This task irritates the skin, takes time and contaminates sterile equipment. This pilot randomised controlled trial aimed to inform a definitive study investigating whether patient education improves umbilical cleanliness in these patients. Methods: To generate data on effect size and sample size, adult patients undergoing elective and emergency laparoscopic abdominal surgery were randomised to an intervention group, who received an education pack to clean their umbilicus prior to surgery, or a control group, who received no pack. Umbilical cleanliness was measured using a novel scale. To assess scale validity and reliability, all umbilici were scored by nine surgeons and surgical trainees using photographs and umbilici were swabbed to estimate bacterial load. Intervention acceptability was assessed via study consent and withdrawal rates and trial feasibility was evaluated using qualitative insights documented by investigators.Results: Seventy-one percent (22/31) of the intervention group had clean umbilici versus 61% (19/31) in the control group. A definitive trial would require 712 participants to show statistical significance between study groups. The umbilical cleanliness scale had excellent interrater and test-retest reliability and a moderate degree of convergent validity with respect to bacterial load. The intervention was highly acceptable to participants, and theatre nurses and surgical trainees were central to trial feasibility. Conclusion: A definitive trial is warranted and would contribute to an evidence-based, standardised approach to preoperative care. Trial registration no. ACTRN12620000278932.