- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Kraków, Polen, 31-501
- 2nd Department of General Surgery
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Hospital length of stay (days)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Compliance with ERAS protocol (%)
Tidsram: 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 (%)
Tidsram: up to 30 days post surgery
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up to 30 days post surgery
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Readmission rate (%)
Tidsram: up to 30 days post surgery
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up to 30 days post surgery
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Michał Pędziwiatr, MD, PhD, 2nd Department of Surgery, Jagiellonian University, Krakow, Poland
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- JagiellonianU-02
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