- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02527967
ERAS in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery
Enhanced Recovery After Surgery Protocol in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Kraków, Polonia, 31-501
- 2nd Department of General Surgery
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Group 1 (≤4 days)
Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days).
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Group 1 (>4 days)
In group 2 were patients whose hospital stay was longer than 4 days.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Hospital length of stay (days)
Lasso di tempo: participants will be followed for the duration of hospital stay, an expected average of 4 days
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participants will be followed for the duration of hospital stay, an expected average of 4 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Compliance with ERAS protocol (%)
Lasso di tempo: participants will be followed for the duration of hospital stay, an expected average of 4 days
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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)
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participants will be followed for the duration of hospital stay, an expected average of 4 days
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Complication rate (%)
Lasso di tempo: up to 30 days post surgery
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up to 30 days post surgery
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Readmission rate (%)
Lasso di tempo: up to 30 days post surgery
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up to 30 days post surgery
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Michał Pędziwiatr, MD, PhD, 2nd Department of Surgery, Jagiellonian University, Krakow, Poland
Pubblicazioni e link utili
Pubblicazioni generali
- Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
- Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- JagiellonianU-02
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .