Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors
4 de janeiro de 2013 atualizado por: Cheung Yui Shan, Pamela Youde Nethersole Eastern Hospital
To compare the two surgical options in their short-term and long term outcomes in the management of early left-sided colorectal cancers.
The hypothesis is that the incisionless approach will result in less postoperative pain and wound related complications.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
For the left-sided colorectal cancer, the investigators performed colectomy with primary anatomosis. Currently the investigators have two methods of minimal access approach to the abdominal cavity in order to complete this operation:
- Conventional Laparoscopic colectomy The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler. Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis
- Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the Transanal Endoscopic Operation (TEO) device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy. Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.
These two operations are essentially identical except for the surgical access for the delivery of specimen and insertion of anvil. Laparoscopic colectomy and the use of Transanal Endoscopic Operation(TEO)device have been practiced in the United States and Europe for over 10 years. Large scale studies in the literature have demonstrated the safety and benefits of laparoscopic colectomy for colonic tumors and the oncological outcomes have not shown to be inferior to open approach. With the use of TEO device, the investigators can perform laparoscopic colectomy without abdominal incision for those early left-sided colonic tumors and thus it can eliminate the wound-related complications theoretically. In order to find out which one is a better procedure, the investigators are carrying out a clinical trial to compare the two surgical options in their short-term and long term outcomes.The results of this study may have an impact on the care of similar patients in the future.
Tipo de estudo
Intervencional
Inscrição (Real)
70
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Hong Kong, China
- Department of Surgery, Pamela Youde Nethersole Eastern Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
patients >18 years old and diagnosed to have operable left-sided colorectal cancers distal to the splenic flexure and proximal to the upper rectum were potential candidates.
Exclusion Criteria:
- Patient who did not give informed consent;
- Patient who were considered unfit for operative treatment;
- Patient presented as acute surgical emergencies, including intestinal obstruction, peritonitis, or pericolic abscess, etc.;
- Patients with metastatic diseases on preoperative work up;
- Patient with synchronous tumours or polyps which necessitate extended or additional resection;
- Patients with large bulky tumor as demonstrated on preoperative colonoscopy or computed tomography showing serosal involvement or invasion to contiguous organs.
- Patients with anal stenosis that precluded the insertion of TEO device
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: incisionless laparoscopic colectomy
incisionless laparoscopic colectomy: Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy.
Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.
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Arm 1:Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy.
Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.
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Comparador Ativo: conventional laparoscopic colectomy
conventional laparoscopic colectomy: The operation is completed by laparoscopic instruments using video laparoscopy.
At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler.
Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis
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Arm 2: Conventional Laparoscopic colectomy The operation is completed by laparoscopic instruments using video laparoscopy.
At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler.
Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis
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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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pain score
Prazo: average of 1 week
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participants will be followed for the pain score during the duration of hospital stay, an expected average of 1 week
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average of 1 week
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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wound complication
Prazo: up to 30 days after the operation
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The patient will be followed for up to 30 days after the operation or till occurrence of event
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up to 30 days after the operation
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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intraoperative blood loss
Prazo: From the start of operation till operation finished
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From the start of operation till operation finished
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From the start of operation till operation finished
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operative time
Prazo: From the start of operation till operation finished
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From the start of operation till operation finished
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From the start of operation till operation finished
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length of hospital stay
Prazo: From the date after operation to date of discharge,an expected average of within 1 week
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From the date after operation to date of discharge,an expected average of within 1 week
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From the date after operation to date of discharge,an expected average of within 1 week
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Yui Shan Cheung, FRACS, Department of Surgery, Pamela Youde Nethersole Eastern Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de junho de 2009
Conclusão Primária (Real)
1 de março de 2012
Conclusão do estudo (Real)
1 de junho de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
29 de novembro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de janeiro de 2013
Primeira postagem (Estimativa)
7 de janeiro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
8 de janeiro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de janeiro de 2013
Última verificação
1 de janeiro de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HKEC-2009-023
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