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ERAS in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery

17. august 2015 opdateret af: Michał Pędziwiatr, Jagiellonian University

Enhanced Recovery After Surgery Protocol in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery

Although there is evidence for reducing complication rate and improving recovery after the implementation of Enhanced Recovery After Surgery (ERAS) protocols into colorectal surgery, most published papers include patients undergoing open resections. The aim was to analyse factors affecting recovery and length of stay (LOS) in patients after laparoscopic colorectal surgery for cancer combined with ERAS protocol.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

All patients were operated using laparoscopic surgery, and the perioperative care was based on pre-established ERAS protocol consisting of 13 pre and intraoperative items. Its principles and criteria for discharge from the hospital were based on the ERAS Society Guidelines.

Investigators analysed which of the factors: gender; age; BMI; ASA (American Society of Anaesthesiologists) physical status; type of surgery (colonic resection vs. rectal resection with total mesorectal excision, TME); stage of cancer; distance between the hospital and place of residence; operative time; intraoperative blood loss significantly prolong LOS (primary length of stay, excluding readmissions). Moreover, the compliance with ERAS protocol and its influence on LOS was analysed.

For the purposes of further analyses the entire group of patients was divided into 2 subgroups depending on the length of their hospital stay. On admission every patient received the information about the target length of stay of 4 days. Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days). In group 2 were patients whose hospital stay was longer than 4 days.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

143

Kontakter og lokationer

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

Studiesteder

  • Polen
      • Kraków, Polen, 31-501
        • 2nd Department of General Surgery

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The analysis included prospectively collected data from consecutive patients electively operated for colorectal cancer in the years 2013-2014. All patients were operated using laparoscopic surgery, and the perioperative care was based on pre-established ERAS protocol consisting of 13 items

Beskrivelse

Inclusion Criteria:

  • colorectal cancer
  • laparoscopic resection
  • perioperative care according to ERAS principles

Exclusion Criteria:

  • Patients submitted initially for open or emergency surgery
  • with complex cancer who required multi-organ resection
  • patients treated with endoscopic techniques using the hybrid TaTME technique (Transanal Total Mesorectal Excision)

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
Group 1 (≤4 days)
Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days).
Group 1 (>4 days)
In group 2 were patients whose hospital stay was longer than 4 days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Hospital length of stay (days)
Tidsramme: participants will be followed for the duration of hospital stay, an expected average of 4 days
participants will be followed for the duration of hospital stay, an expected average of 4 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Compliance with ERAS protocol (%)
Tidsramme: participants will be followed for the duration of hospital stay, an expected average of 4 days
Compliance (%) will be calculated as the number of pre and intraoperative interventions fulfilled/13*100% (number of pre- and intraoperative protocol elements included into compliance calculations)
participants will be followed for the duration of hospital stay, an expected average of 4 days
Complication rate (%)
Tidsramme: up to 30 days post surgery
up to 30 days post surgery
Readmission rate (%)
Tidsramme: up to 30 days post surgery
up to 30 days post surgery

Samarbejdspartnere og efterforskere

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

Sponsor

Jagiellonian University

Efterforskere

  • Ledende efterforsker: Michał Pędziwiatr, MD, PhD, 2nd Department of Surgery, Jagiellonian University, Krakow, Poland

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

1. januar 2013

Primær færdiggørelse (Faktiske)

1. september 2014

Studieafslutning (Faktiske)

1. februar 2015

Datoer for studieregistrering

Først indsendt

13. august 2015

Først indsendt, der opfyldte QC-kriterier

17. august 2015

Først opslået (Skøn)

19. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • JagiellonianU-02

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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