Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

17. august 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

143

Kontakter og plasseringer

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

Studiesteder

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

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

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

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

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

Sponsor

Jagiellonian University

Etterforskere

Hovedetterforsker: Michał Pędziwiatr, MD, PhD, 2nd Department of Surgery, Jagiellonian University, Krakow, Poland

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

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. januar 2013

Primær fullføring (Faktiske)

1. september 2014

Studiet fullført (Faktiske)

1. februar 2015

Datoer for studieregistrering

Først innsendt

13. august 2015

Først innsendt som oppfylte QC-kriteriene

17. august 2015

Først lagt ut (Anslag)

19. august 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)