- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Descrição detalhada
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 de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Kraków, Polônia, 31-501
- 2nd Department of General Surgery
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Hospital length of stay (days)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Compliance with ERAS protocol (%)
Prazo: 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 (%)
Prazo: up to 30 days post surgery
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up to 30 days post surgery
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Readmission rate (%)
Prazo: up to 30 days post surgery
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up to 30 days post surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michał Pędziwiatr, MD, PhD, 2nd Department of Surgery, Jagiellonian University, Krakow, Poland
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- JagiellonianU-02
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