Evidence map›Paper›PMID 32293519›Full record

ArticleTrials2020

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).

Marius Schwab, Niall Brindl, Alexander Studier-Fischer, Thomas Tu, Julia Gsenger, Max Pilgrim, Mirco Friedrich, Pia-Elena Frey, Christina Achilles, Alexander Leuck and 6 more

Abstract readComparative StudyClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Marius SchwabFaculty of Medicine, University of Heidelberg, Im Neuenheimer Feld 346, 69120, Heidelberg, Germany.
Niall BrindlFaculty of Medicine, University of Heidelberg, Im Neuenheimer Feld 346, 69120, Heidelberg, Germany.
Alexander Studier-FischerFaculty of Medicine, University of Heidelberg, Im Neuenheimer Feld 346, 69120, Heidelberg, Germany.
Thomas TuFaculty of Medicine, University of Heidelberg, Im Neuenheimer Feld 346, 69120, Heidelberg, Germany.
Julia GsengerFaculty of Medicine, University of Heidelberg, Im Neuenheimer Feld 346, 69120, Heidelberg, Germany.
Max PilgrimFaculty of Medicine, University of Heidelberg, Im Neuenheimer Feld 346, 69120, Heidelberg, Germany.
Mirco FriedrichFaculty of Medicine, University of Heidelberg, Im Neuenheimer Feld 346, 69120, Heidelberg, Germany.
Pia-Elena FreyFaculty of Medicine, University of Heidelberg, Im Neuenheimer Feld 346, 69120, Heidelberg, Germany.
Christina AchillesFaculty of Medicine, University of Heidelberg, Im Neuenheimer Feld 346, 69120, Heidelberg, Germany.
Alexander LeuckFaculty of Medicine, University of Heidelberg, Im Neuenheimer Feld 346, 69120, Heidelberg, Germany.
Thore BürgelHealth Data Science Unit, University Hospital Heidelberg, BioQuant, Im Neuenheimer Feld 267, 69120, Heidelberg, Germany.
Manuel FeisstInstitute of Medical Biometry and Informatics, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Christina KloseInstitute of Medical Biometry and Informatics, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Solveig TenckhoffCHIR-Net Coordination Centre at the Study Centre of the German Surgical Society (SDGC), University Hospital Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Colette Dörr-HarimDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
André L MihaljevicDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. mihaljevic@uni-heidelberg.de.ORCID http://orcid.org/0000-0003-1902-657X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostoperative 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.

methodsThis 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 registrationDeutsches Register Klinischer Studien (DRKS, German Clinical Trials Register): DRKS00016755, UTN U1111-1228-3320. Registered on 06.03.2019.

Indexed as

AbdomenAdultCost-Benefit AnalysisEarly AmbulationElective Surgical ProceduresFeedbackFitness TrackersGermanyHumansLength of StayMulticenter Studies as TopicPostoperative ComplicationsRandomized Controlled Trials as TopicRecovery of FunctionSafetyTime FactorsComprehensive Complication Index (CCI)Dindo-ClavienMajor abdominal surgeryMobilisationPostoperative complicationsPostoperative outcomesQuality of lifeRandomised controlled trialRecovery of functionWearable fitness trackers

Identifiers

PMID32293519
PMCPMC7092422

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.