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Enhanced Recovery After Hepatic Surgery (MultiPAS). (MultiPAS)

1. april 2016 oppdatert av: University Hospital, Angers

Enhanced Recovery After Hepatic Surgery Versus Conventional Care : a Controlled Randomized Monocentric Trial (MultiPAS).

Enhanced rehabilitation programs are based on new therapies and treatment combinations to reduce the length of hospitalization, duration of postoperative convalescence, morbidity, but also the overall cost of care. The operating stress and hypercatabolic conditions surrounding the surgery are sources of complications. In this enhanced rehabilitation approach, the principle is to fight through a series of actions against this surgical stress. Several North American studies, Chinese, Scandinavian or Batavian have shown the feasibility and the interest of enhanced perioperative rehabilitation in liver surgery. Nevertheless, there is not until now French data concerning the assessment of enhanced rehabilitation in liver surgery. The main objective of the study is to compare the effectiveness of the implementation of a multimodal management program after liver surgery in a French university center compared to conventional care. Secondary objectives of the study are to compare an enhanced rehabilitation program in liver surgery versus conventional treatment in terms of morbidity and mortality in the immediate postoperative period and until day 90, length of hospital stay, blood loss and the delay to bowel mobility recovery. Compliance to the program in both groups will also be evaluated.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
    • Maine et Loire
      • Angers, Maine et Loire, Frankrike, 49100
        • Rekruttering
        • CHU Angers
        • Ta kontakt med:
        • Ta kontakt med:
          • Julien Barbieux, MD
          • Telefonnummer: 02 41 35 36 18

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 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patient to be operated on for hepatectomy in Universitary Hospital of Angers
  • No emergency surgery
  • No bilio-digestive anastomosis
  • Body Mass Index between 18 and 40 kg/m2
  • Preoperative morbidity status graded with the American Society of Anesthesiologists (ASA) between I to III
  • Affiliated to the national health insurance

Exclusion Criteria:

  • Pregnant woman
  • Patient who doesn't speack french
  • Colorectal surgery combined
  • Postoperative stay predictable in critical care unit
  • Patient under law protection

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Conventional care

Preoperative consultation Information support conventional perioperative No bowel preparation

Day before surgery Normal diet until midnight No carbohydrate loading Premedication with anxiolytic

Operative day Conventional general anaesthesia Classic management perfused volumes Conventional use of drains at the operative site Standard nasogastric drainage Conventional analgesia protocol

Postoperative time Mobilization from J1 Progressive refeeding Progressive removal of venous, arterial and urinary catheters. Gradual recovery of the usual treatment from J1 Breathe physiotherapy depending on the clinical course No stimulation of intestinal transit
Annen: Konvensjonell omsorg
Eksperimentell: Enhanced recovery

Preoperative consultation Specific information about the enhanced rehabilitation No bowel preparation Immunonutrition for the 7 preoperative days

Day before surgery Minimal preoperative fasting No premedication Carbohydrate loading

Operative day Optimized general anesthesia Reduced volumes perfused Limiting use of drains at the operative site Reduced doses of morphine Local anesthetic usage No standard use of nasogastric drainage

Postoperative time Stimulation mobilization from D0 Refeeding "on demand " from D0 Early removal of venous, arterial and urinary catheters. J1 recovery from the majority of the usual treatment Breathe physiotherapy from D0 to D5 Ileus prevention by chewing gum
Annen: Enhanced recovery

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Day number to functional recovery
Tidsramme: 90 days

The evaluation of time to functional recovery is scored once a day. A patient is fully functionally recovered when all of the following criteria are satisfied:

  1. adequate pain control with oral analgesia: Post-operative pain is rated by the numeric rating scale. Nurses ask patients the intensity of their current pain on a scale of 0 (no pain) to 10 (worst possible pain). To satisfy this criterion, patient must rate their pain between 0 to 3 with only oral analgesics.
  2. restoration of mobility to an independent level We decided to use the Groningen Activity Restriction Scale for rated the difference between preoperative and postoperative mobility level. To satisfy this criterion, patient must have the same score in postoperative.
  3. absence of intravenous fluid administration for at least 24 hours.
  4. ability to eat solid foods well tolerated for at least 24 hours to satisfy this criterion.
  5. normal or decreasing serum bilirubin level and international normalised ratio.
90 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Angers

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

1. april 2016

Primær fullføring (Forventet)

1. mars 2018

Datoer for studieregistrering

Først innsendt

11. mars 2016

Først innsendt som oppfylte QC-kriteriene

16. mars 2016

Først lagt ut (Anslag)

22. mars 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. april 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. april 2016

Sist bekreftet

1. april 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2015-A01806-43

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