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TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes (TRAM)

15. november 2013 opdateret af: Women's College Hospital

Expedited Discharge of Patients Undergoing Pedicled TRAM Flap Breast Reconstruction Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes

Specific Aim: To assess the quality of recovery of patients following early discharge (18 hrs) after pedicled TRAM flap breast reconstruction. Quality of recovery will be assessed using a 27-item validated questionnaire, QoR-27 at discharge, and on Post Operative Days (POD) 2, 4 and 7. In addition a 100 mm Visual Analog Score (VAS) for Pain will be completed on discharge from the recovery room, discharge from hospital and on POD 2, 4 and 7.

Clinical Relevance: Postoperative recovery is a complex process related to various outcomes such as physiological endpoints, incidence of adverse events and change in psychological status. Previous studies of recovery after surgery and anesthesia have focused primarily on the physiological endpoints and the incidence of adverse events. Much of the work has occurred in specialties dealing with chronic disease states such as cancer, rheumatology and musculoskeletal disorders. There is clearly a need to focus on recovery outcome measures in the ambulatory population for postoperative recovery. Here the investigators propose to measure postoperative recovery outcomes within the first week following a TRAM flap reconstructive procedure using a validated postoperative quality of recovery instrument (QoR-27) and a 100 mm VAS for pain.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

Women's College Hospital is the first and only independent ambulatory care hospital in Ontario, and the only hospital in Ontario with a primary focus on women's health. Patients undergoing breast reconstruction following breast cancer at our institution are now undergoing expedited discharge at 18 hrs postoperatively. To facilitate next day discharge, a multidisciplinary group was formed to determine the best evidence for perioperative care to ensure patient safety and excellent postoperative recovery. Minimizing length of stay has obvious cost savings for hospitals, but for patients the advantages include minimizing exposure to hospital-acquired infections and an earlier return to their more familiar home environment. The need to balance the advantage of early discharge to patient complications, however, must be addressed. As other hospitals across the country face the same length of stay constraints as has been our experience, this study will provide important data on the quality of recovery of patients undergoing early discharge following breast reconstructive surgery.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

60

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B2
        • Women's College Hospital

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

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Reconstructive breast cancer patients

Beskrivelse

Inclusion Criteria:

  • Women undergoing any type of TRAM flap
  • Age<75 yrs
  • Non-smoker

Exclusion Criteria:

  • History of chronic pain or psychiatric disturbance
  • History of chronic use of opioid medications
  • Allergy to local anesthesia or opioid medication
  • Inability to communicate in English
  • BMI>35

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Reconstructive breast cancer patients
Patients having unilateral, bilateral immediate or delayed TRAM flaps who are discharged 18 hours postoperatively

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Det primære resultatmål er kvaliteten af ​​restitution ved udskrivelse som vurderet af QoR27
Tidsramme: I gennemsnit 72-96 timer efter operationen
Patienten vil blive kontaktet af undersøgelseskoordinatoren 4 dage efter operationen for at administrere Quality of Recovery Questionnaire (QoR27)
I gennemsnit 72-96 timer efter operationen
Det primære resultatmål er kvaliteten af ​​bedring efter operationen som vurderet af QoR27
Tidsramme: I gennemsnit 7-8 dage postoperativt
Patienten vil blive kontaktet af undersøgelseskoordinatoren 7 dage efter deres operation for at administrere Quality of Recovery Questionnaire (QoR27)
I gennemsnit 7-8 dage postoperativt
The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
Tidsramme: On average between 18 and 24 hours postoperatively
The patient will be met with by the study coordinator, just before discharge to administer the Quality of Recovery Questionnaire (QoR27)
On average between 18 and 24 hours postoperatively
The primary outcome measure is the quality of recovery post operatively, as assessed by the QoR27
Tidsramme: on average between 48-72 hours postoperatively
The patient will be contacted by the study coordinator, 2 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)
on average between 48-72 hours postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The secondary outcome measure is the quality of recovery as assessed by the VAS pain score
Tidsramme: This outcome will be done at the exact same time as the measurements of Quality of Recovery listed above
These scores will be compared
This outcome will be done at the exact same time as the measurements of Quality of Recovery listed above

Samarbejdspartnere og efterforskere

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

Sponsor

Women's College Hospital

Samarbejdspartnere

Ontario Ministry of Health and Long Term Care
The Physicians' Services Incorporated Foundation

Efterforskere

  • Ledende efterforsker: John L Semple, MD, MSc, FRCSC, FACS, Women's College Hospital
  • Studieleder: Pamela J Morgan, MD, CCFP, FRCPC, Women's College Hospital

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

1. juli 2011

Primær færdiggørelse (Faktiske)

1. august 2013

Studieafslutning (Forventet)

1. januar 2014

Datoer for studieregistrering

Først indsendt

21. juni 2011

Først indsendt, der opfyldte QC-kriterier

20. september 2011

Først opslået (Skøn)

22. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. november 2013

Sidst verificeret

1. november 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2010-0050-E

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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