Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage (DOUBLE CHECK)
Enhanced Perioperative Care for Improving Outcomes After Colorectal Resection by Implementation of Best Practice for the Prevention of Anastomotic Leakage - Double Check Study: Protocol for a Multicenter Open-label Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Rationale Colorectal anastomotic leakage (CAL) remains a severe complication following surgery with a reported incidence of 3-19% worldwide. Recent research has identified several modifiable peri-operative CAL risk factors, suggesting that the intraoperative condition of the patient plays an important role in CAL development.
Objective To successfully implement an enhanced perioperative care protocol, focusing on optimizing the intraoperative condition of the patient to minimalize exposure to CAL risk factors. Secondly, to investigate whether implementation of this new guideline results in a better intraoperative condition and a decreased CAL rate as compared to current practice.
Study design An open-label multicenter design with historical cohort in nine participating hospitals.
Study population All adult patients that are scheduled for a colorectal resection with creation of a primary anastomosis.
Intervention An enhanced perioperative best practice protocol. The Double Check bundle exists out of interventions applicable without the introduction of new material to the operating room, on top of usual care. The protocol is based on the results of our previous large, multicenter, international observational cohort study (LekCheck study), systematic literature analyses, an inventory in current protocols on peri-operative care and expert opinion. Consensus is reached with colorectal surgeons from all participating centers. The final protocol was reviewed critically by experts in the field of colorectal surgery before implementation.
Comparison 1592 historical patients that were treated with standard practice (LekCheck study group). In addition the anastomotic leakage rates from the national registry of the period after the LekCheck study and before the start of the Double Check study will be used for comparison.
Endpoints Compliance to the study protocol, the patient's intraoperative condition and exposure to modifiable intraoperative risk factors, 30-day CAL and other postoperative complications according to Clavien-Dindo classification. Follow-up will be 90 days after colorectal resection.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Antwerpen, Bélgica
- UZA
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Limburg
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Helmond, Limburg, Holanda
- Elkerliek
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Maastricht, Limburg, Holanda
- Maastricht UMC+
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Noord Brabant
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Den Bosch, Noord Brabant, Holanda
- Jeroen Bosch Ziekenhuis
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Uden, Noord Brabant, Holanda
- Bernhoven
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Veldhoven, Noord Brabant, Holanda
- Maxima Medisch Centrum
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Noord Holland
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Amsterdam, Noord Holland, Holanda
- Amsterdam UMC
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Hoorn, Noord Holland, Holanda
- Dijklander Ziekenhuis
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Zeeland
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Terneuzen, Zeeland, Holanda
- ZorgSaam
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 18 and above
- Bowel (small intestine/colon/rectal) resection with creation of a primary anastomosis
- Ability to give informed consent
Exclusion Criteria:
- The need for emergency surgery
- Scheduled operation concerning a reoperation for complications from recent surgery (within 3 months after the initial procedure).
- The inability to read or understand informed consent material
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Double Check enhanced perioperative care protocol
Perioperative care according to a best practice protocol focussing on optimizing the intraoperative condition of the patient and thereby minimalize exposure to 6 known modifiable independent intraoperative risk factors: anemia, hypothermia, epidural anesthesia, vasopressor drug administration, incorrect antibiotic prophylaxis and hyperglycemia.
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See arm/group description
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Sem intervenção: Current practice
Perioperative care according to usual practice.
Historical controls from the previously conducted LekCheck study will be used as replacement of a control arm.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of modifiable intraoperative CAL risk factors present during surgery as assessed by the DoubleCheck list
Prazo: Intraoperative phase
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The primary outcome of the study is the intraoperative condition of the patient measured by the number of modifiable intraoperative CAL risk factors present in the patient. During the operation, the Double Check list will be completed. The list exists of 6 risk factors of interest:
The number of risk factors present will be counted and a score of 0 to 6 will be given to each individual patient. |
Intraoperative phase
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Colorectal anastomotic leakage (CAL)
Prazo: 30 days after surgery
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Defined as a grade B or C according to the ISREC classification
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30 days after surgery
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Postoperative complications
Prazo: 30 days after surgery
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Defined as any adverse event occurring in the postoperative period until 30 days after surgery and graded according to the Dindo-Clavien classification
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30 days after surgery
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Postoperative mortality
Prazo: 30 days after surgery
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Measured as rate of death at 30-day follow-up
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30 days after surgery
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Hospital Stay
Prazo: 30 days after surgery
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Length of hospital and intensive care unit stay
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30 days after surgery
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Readmission
Prazo: 30 days after surgery
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30-day readmission rate
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30 days after surgery
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Huisman DE, Reudink M, van Rooijen SJ, Bootsma BT, van de Brug T, Stens J, Bleeker W, Stassen LPS, Jongen A, Feo CV, Targa S, Komen N, Kroon HM, Sammour T, Lagae EAGL, Talsma AK, Wegdam JA, de Vries Reilingh TS, van Wely B, van Hoogstraten MJ, Sonneveld DJA, Veltkamp SC, Verdaasdonk EGG, Roumen RMH, Slooter GD, Daams F. LekCheck: A Prospective Study to Identify Perioperative Modifiable Risk Factors for Anastomotic Leakage in Colorectal Surgery. Ann Surg. 2022 Jan 1;275(1):e189-e197. doi: 10.1097/SLA.0000000000003853.
- van Rooijen SJ, Huisman D, Stuijvenberg M, Stens J, Roumen RMH, Daams F, Slooter GD. Intraoperative modifiable risk factors of colorectal anastomotic leakage: Why surgeons and anesthesiologists should act together. Int J Surg. 2016 Dec;36(Pt A):183-200. doi: 10.1016/j.ijsu.2016.09.098. Epub 2016 Oct 15. Review.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2020.0634
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Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
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