Enhanced Perioperative Mobilization (EPM) Trial (EPMIII)
19. oktober 2017 oppdatert av: Technische Universität Dresden
Usage of Activity Tracking in Major Visceral Surgery - the Enhanced Perioperative Mobilization (EPM) Trial
Randomized Controlled Trial to monitor and increase the postoperative mobilization of the patients undergoing major visceral surgery by giving a continuous autofeedback of the step count using activity tracking wristbands.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
Patients undergoing elective open and laparoscopic surgery of colon, rectum, stomach, pancreas and liver for any indication will be included.
Further inclusion criteria are: age between 18-75 years, ASA score < 4, and a signed informed consent.
Patients are stratified into two subgroups (laparoscopic and open surgery) and will be randomized 1:1 for an autofeedback of their step-count using an activity tracker wristband or for the control group without autofeedback.
Sample size (n = 29 patients in each of the four groups, overall n = 119) is calculated on an assumed difference in step-count of 250 steps daily (intervention versus control group).
The primary study endpoint is the step-count during the first five postoperative days; secondary endpoints are the percentage of patients in the two groups, who master the predefined mobilization (step-count) targets, the assessment of additional activity data from the devices, the assessment of the preoperative mobility, length of hospital and intensive care unit stay, number of patients who receive physiotherapy, 30-day mortality, and the overall 30-day morbidity.
Studietype
Intervensjonell
Registrering (Faktiske)
110
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Dresden, Tyskland, 01309
- Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- elective laparoscopic and open surgery of the colon and rectum (colectomy, hemicolectomy, segment resection, rectum extirpation, deep anterior rectum resection, sigmoid resection, proctocolectomy), of the stomach (total, subtotal and atypical gastric resections), of the pancreas (any kind of pancreatic resections), and of the liver (hemihepatectomy, atypical resection, anatomical segment resection)
- ASA score < IV
- completed informed consent.
Exclusion Criteria:
- emergency surgery
- mental inability to complete postoperative assessment protocols
- preoperatively immobile patients
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Laparoscopic surgery, control
The control group is wearing an activity tracker wristband with covered display, so that the step count can't be read out.
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Aktiv komparator: Laparoscopic surgery, intervention
activity tracking for autofeedback
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The intervention group receives an unblinded wristband.
The handling of the activity trackers is explained to the patients and a predefined mobilization end-point (step-count) for the first five PODs is targeted.
The target step-count was set at the 85% quartile obtained from a previous pilot study.
The patients are assessed and monitored two times daily between 9 and 11 o'clock AM and between 3 and 5 o'clock PM by a surgical fellow or a study nurse throughout their hospital stay for read-out of the step count, assurance of the proper use and functioning, and for communication of the autofeedback.
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Ingen inngripen: Open surgery, control
The control group is wearing an activity tracker wristband with covered display, so that the step count can't be read out.
|
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Aktiv komparator: Open surgery, intervention
activity tracking for autofeedback
|
The intervention group receives an unblinded wristband.
The handling of the activity trackers is explained to the patients and a predefined mobilization end-point (step-count) for the first five PODs is targeted.
The target step-count was set at the 85% quartile obtained from a previous pilot study.
The patients are assessed and monitored two times daily between 9 and 11 o'clock AM and between 3 and 5 o'clock PM by a surgical fellow or a study nurse throughout their hospital stay for read-out of the step count, assurance of the proper use and functioning, and for communication of the autofeedback.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Median Step count
Tidsramme: First to fifth postoperative day
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First to fifth postoperative day
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Dødelighet
Tidsramme: 30 dager
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30 dager
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Lengde på sykehusopphold
Tidsramme: 30 dager
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30 dager
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Lengde på intensivavdelingen
Tidsramme: 30 dager
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30 dager
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Percentage of patients, who master the predefined mobilization (step-count) targets
Tidsramme: First to fifth postoperative day
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First to fifth postoperative day
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Distance (km)
Tidsramme: First to fifth postoperative day
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Assessed by the activity tracker wristband
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First to fifth postoperative day
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Activity time (min.)
Tidsramme: First to fifth postoperative day
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Assessed by the activity tracker wristband
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First to fifth postoperative day
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inactivity
Tidsramme: First to fifth postoperative day
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Assessed by the activity tracker wristband
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First to fifth postoperative day
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calorie consumption (kcal)
Tidsramme: First to fifth postoperative day
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Assessed by the activity tracker wristband
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First to fifth postoperative day
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Compliance
Tidsramme: First to fifth postoperative day
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Compliance to wear the wrist band
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First to fifth postoperative day
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Assessment of the preoperative mobility
Tidsramme: Preoperative
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Measured by International Physical Activity Questionnaire (IPAQ)
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Preoperative
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Amount of patients which receive physiotherapy
Tidsramme: First to fifth postoperative day
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First to fifth postoperative day
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Overall morbidity
Tidsramme: 30 days
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According the Clavien-Dindo classification
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30 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Thilo Welsch, MD, MBA, Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden, Germany
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Wolk S, Linke S, Bogner A, Sturm D, Meissner T, Mussle B, Rahbari NN, Distler M, Weitz J, Welsch T. Use of Activity Tracking in Major Visceral Surgery-the Enhanced Perioperative Mobilization Trial: a Randomized Controlled Trial. J Gastrointest Surg. 2019 Jun;23(6):1218-1226. doi: 10.1007/s11605-018-3998-0. Epub 2018 Oct 8.
- Wolk S, Meissner T, Linke S, Mussle B, Wierick A, Bogner A, Sturm D, Rahbari NN, Distler M, Weitz J, Welsch T. Use of activity tracking in major visceral surgery-the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial. Trials. 2017 Feb 21;18(1):77. doi: 10.1186/s13063-017-1782-1.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
26. juli 2016
Primær fullføring (Faktiske)
20. juli 2017
Studiet fullført (Faktiske)
20. juli 2017
Datoer for studieregistrering
Først innsendt
15. juni 2016
Først innsendt som oppfylte QC-kriteriene
12. juli 2016
Først lagt ut (Anslag)
15. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. oktober 2017
Sist bekreftet
1. oktober 2017
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- TW-003
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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