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Enhanced Perioperative Mobilization (EPM) Trial (EPMIII)

19. oktober 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

110

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Dresden, Tyskland, 01309
        • Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Aktiv komparator: Laparoscopic surgery, intervention
activity tracking for autofeedback
Enhed: 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.
Ingen indgriben: 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.
Aktiv komparator: Open surgery, intervention
activity tracking for autofeedback
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Median Step count
Tidsramme: First to fifth postoperative day
First to fifth postoperative day

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dødelighed
Tidsramme: 30 dage
30 dage
Længde af hospitalsophold
Tidsramme: 30 dage
30 dage
Længde af intensivophold
Tidsramme: 30 dage
30 dage
Percentage of patients, who master the predefined mobilization (step-count) targets
Tidsramme: First to fifth postoperative day
First to fifth postoperative day
Distance (km)
Tidsramme: First to fifth postoperative day
Assessed by the activity tracker wristband
First to fifth postoperative day
Activity time (min.)
Tidsramme: First to fifth postoperative day
Assessed by the activity tracker wristband
First to fifth postoperative day
inactivity
Tidsramme: First to fifth postoperative day
Assessed by the activity tracker wristband
First to fifth postoperative day
calorie consumption (kcal)
Tidsramme: First to fifth postoperative day
Assessed by the activity tracker wristband
First to fifth postoperative day
Compliance
Tidsramme: First to fifth postoperative day
Compliance to wear the wrist band
First to fifth postoperative day
Assessment of the preoperative mobility
Tidsramme: Preoperative
Measured by International Physical Activity Questionnaire (IPAQ)
Preoperative
Amount of patients which receive physiotherapy
Tidsramme: First to fifth postoperative day
First to fifth postoperative day
Overall morbidity
Tidsramme: 30 days
According the Clavien-Dindo classification
30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Technische Universität Dresden

Efterforskere

  • Ledende efterforsker: Thilo Welsch, MD, MBA, Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden, Germany

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. juli 2016

Primær færdiggørelse (Faktiske)

20. juli 2017

Studieafslutning (Faktiske)

20. juli 2017

Datoer for studieregistrering

Først indsendt

15. juni 2016

Først indsendt, der opfyldte QC-kriterier

12. juli 2016

Først opslået (Skøn)

15. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • TW-003

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Leverresektion

Kliniske forsøg med activity tracking for autofeedback

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CROs in Germany

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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