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Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Abdominal Surgery | Study protocol

Postoperative complications and mobilisation following major abdominal surgery with vs. without fitness tracker-based feedback (EXPELLIARMUS): study protocol for a student-led multicentre randomised controlled trial (CHIR-Net SIGMA study group)

Authors: Marius Schwab, Niall Brindl, Alexander Studier-Fischer, Thomas Tu, Julia Gsenger, Max Pilgrim, Mirco Friedrich, Pia-Elena Frey, Christina Achilles, Alexander Leuck, Thore Bürgel, Manuel Feisst, Christina Klose, Solveig Tenckhoff, Colette Dörr-Harim, André L. Mihaljevic

Published in: Trials | Issue 1/2020

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Abstract

Background

Postoperative complications following major abdominal surgery are frequent despite progress in surgical technique and perioperative care. Early and enhanced postoperative mobilisation has been advocated to reduce postoperative complications, but it is still unknown whether it can independently improve outcomes after major surgery. Fitness trackers (FTs) are a promising tool to improve postoperative mobilisation, but their effect on postoperative complications and recovery has not been investigated in clinical trials.

Methods

This is a multicentre randomised controlled trial with two parallel study groups evaluating the efficacy of an enhanced and early mobilisation protocol in combination with FT-based feedback in patients undergoing elective major abdominal surgery. Participants are randomly assigned (1:1) to either the experimental group, which receives daily step goals and a FT giving feedback about daily steps, or the control group, which is mobilised according to hospital standards. The control group also receives a FT, however with a blackened screen; thus no FT-based feedback is possible. Randomisation will be stratified by type of surgery (laparoscopic vs. open). The primary endpoint of the study is postoperative morbidity within 30 days measured via the Comprehensive Complication Index. Secondary endpoints include number of steps as well as a set of functional, morbidity and safety parameters. A total of 348 patients will be recruited in 15 German centres. The study will be conducted and organised by the student-led German Clinical Trial Network SIGMA.

Discussion

Our study aims at investigating whether the implementation of a simple mobilisation protocol in combination with FT-based feedback can reduce postoperative morbidity in patients undergoing major abdominal surgery. If so, FTs would offer a cost-effective intervention to enhance postoperative mobilisation and improve patient outcomes.

Trial registration

Deutsches Register Klinischer Studien (DRKS, German Clinical Trials Register): DRKS00016755, UTN U1111-1228-3320. Registered on 06.03.2019.
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Metadata
Title
Postoperative complications and mobilisation following major abdominal surgery with vs. without fitness tracker-based feedback (EXPELLIARMUS): study protocol for a student-led multicentre randomised controlled trial (CHIR-Net SIGMA study group)
Authors
Marius Schwab
Niall Brindl
Alexander Studier-Fischer
Thomas Tu
Julia Gsenger
Max Pilgrim
Mirco Friedrich
Pia-Elena Frey
Christina Achilles
Alexander Leuck
Thore Bürgel
Manuel Feisst
Christina Klose
Solveig Tenckhoff
Colette Dörr-Harim
André L. Mihaljevic
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4220-8

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