NDLI: 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)

Content Provider	Springer Nature : BioMed Central
Author	Schwab, Marius Brindl, Niall Studier-Fischer, Alexander Tu, Thomas Gsenger, Julia Pilgrim, Max Friedrich, Mirco Frey, Pia-Elena Achilles, Christina Leuck, Alexander Bürgel, Thore Feisst, Manuel Klose, Christina Tenckhoff, Solveig Dörr-Harim, Colette Mihaljevic, André L.
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.
Related Links	https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-020-4220-8.pdf
Ending Page	13
Page Count	13
Starting Page	1
File Format	HTM / HTML
ISSN	17456215
DOI	10.1186/s13063-020-4220-8
Journal	Trials
Issue Number	1
Volume Number	21
Language	English
Publisher	BioMed Central
Publisher Date	2020-03-23
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Wearable fitness trackers Postoperative complications Major abdominal surgery Quality of life Recovery of function Comprehensive Complication Index (CCI) Mobilisation Postoperative outcomes Dindo-Clavien Randomised controlled trial Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Medicine Pharmacology (medical)
Journal Impact Factor	2/2023
5-Year Journal Impact Factor	2.1/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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