Active and passive work breaks during simulated laparoscopy among laparoscopic surgeons: study protocol for a controlled, randomised cross-over laboratory trial

Abstract

Introduction: Laparoscopy has partially replaced open surgery due to the lower infection rate for the patient and hence better and shorter recovery. However, the surgeon's physical load is higher due to longer duration static and awkward body postures, increasing the risk for developing work-related musculoskeletal disorders. Interventions of an organisational nature are work breaks, being either passive or active. The primary objectives of this study are to determine whether passive and active work breaks lead to less discomfort than no work breaks and whether active work breaks lead to less discomfort than passive work breaks.

Methods and analysis: A controlled, randomised cross-over trial will be performed in the laboratory, of which its protocol is described here according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement. Recruitment of 21 laparoscopic surgeons started in April 2019 and the study is ongoing. The participating surgeons will perform three 1.5 hour experimental conditions, one without work breaks, one with 2.5 min passive work breaks including rest, and one with 2.5 min active work breaks including mobility and stretching exercises. The work breaks will be taken after 30 and 60 min of work. During the experiments, outcomes will be recorded. The primary outcome is rating of perceived discomfort measured on an 11-point numeric rating scale. The secondary outcomes are performance, muscle activity of selected muscles, upper body angles, heart rate, workload and subjective evaluation of both interventions. The collected data will be tested using a one-way or two-factorial repeated-measures analysis of variance.

Ethics and dissemination: Ethical approval of the study protocol was received by the local medical ethical committee of the University of Tübingen in February 2019 (no 618/2018BO2). The results of this study will be presented at national and international conferences, submitted for publications in peer-reviewed journals and serve as the starting point for a feasibility study.

Trial registration number: NCT03715816.

Keywords: minimally invasive surgery; occupational & industrial medicine; physiology; protocols & guidelines; public health.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Flow chart displaying the process of the cross-over study. Participants will be randomly allocated by the principal investigator (TL) to one of the six possible orders of the three conditions.

Figure 2

The six tasks performed within the Pelvic Trainer: hot-wire (A), peg-transfer (B), pick-and-place (C), pick-and-tighten (D), pick-and-thread (E), pull-and-stick (F).

Figure 3

The 90+5 min time course of tasks including work breaks; for the condition without breaks, the blue blocks disappear. Each block and letter relates to a task, including the hot-wire (A), peg-transfer (B), pick-and-place (C), pick-and-tighten (D), pick-and-thread (E) and pull-and-stick task (F). The arrows indicate the time points of recordings of rating of perceived discomfort (T1-8) and recordings of muscle activity, upper body posture and heart rate (B1-9) during the peg-transfer task (B).

Figure 4

Left: guiding questions to ask the subject’s perceived feeling of discomfort. Right: body map adapted from Corlett to define the body regions.