- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07655856
Inferior Mesenteric Artery First Combined With Complete Medial Approach for Laparoscopic Splenic Flexure Mobilization in Left Sided Colorectal Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Laparoscopic left-sided colon cancer radical resection is primarily employed for the treatment of tumors located in distal transverse colon , splenic flexure of colon, descending colon, and proximal segment of the sigmoid colon. Numerous factors impact the difficulty of surgery, with research suggesting that mobilization of the splenic flexure independently predicts longer operative times in laparoscopic left-sided colon cancer radical resection . Splenic flexure mobilization is independently associated with an increased risk of splenic injury, which contributes to elevated short-term and long-term mortality risks in patients. The crucial aspect of radical surgery is complete mesocolic excision (CME) with central vascular ligation and the Japanese D3 lymphadenectomy. For tumors located in descending colon and sigmoid-descending junction, the lymph node dissection range includes the central lymph node group (No.253) at the root of the inferior mesenteric artery (IMA) . In cases of cancer in the left half of the transverse colon or in the splenic flexure of colon, in addition to IMA root lymph node dissection, it is imperative to perform dissection of lymph nodes (No.223) at the root of the middle colic artery (MCA).Therefore, for laparoscopic left-sided colon cancer radical resection, ensuring the safety of splenic flexure mobilization and maintaining the quality of lymph nodes dissection are both crucial.
Currently, traditional surgical approaches for laparoscopic left-sided colon cancer radical resection include the medial approach, lateral approach, anterior approach, and various combinations of these methods. Due to variations in anatomical understanding, many teams propose the combined application of multiple approaches, each demonstrating a certain level of safety and feasibility.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: omar mohamed doctor, master
- Número de teléfono: +0201025104556
- Correo electrónico: Omar_Mokbel@aun.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: momen shalkamy abdelgwad, phd
- Número de teléfono: 01017520093
- Correo electrónico: moamen.shalkamy@aun.edu.eg
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Patients aged 18-70 years old with confirmed colorectal cancer diagnosis by histopathology with obligatory splenic flexure mobilization and had laparoscopic surgery with curative intent were included.
Exclusion Criteria:
- Those younger than 18 years or older than 70 years.
- Those undergoing non-cancer resections, or completion surgery or palliative procedures.
- Those with locally advanced ( extra colonic extension ) or metastatic tumors.
- Those with advanced comorbidities ( laparoscopy is contraindicated )
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: inferior mesenteric artery first with complete medial approach
|
The patient was positioned in the modified lithotomy position with the main surgeon standing in between the abducted legs. The patient's head is lowered by 15° (Trendelenburg position), and table was 20° right-tilted. The position was adjusted at the time of splenic flexure mobilization to head elevation by 20° to let the small bowel go down toward the pelvis. Five ports were introduced [Figure 1]: a 10-mm port in the midline 4 cm above the umbilicus to increase the field of view, a second 5 mm port in the right midclavicular line just below the umbilicus, a third 10-12-mm port at the right midclavicular line in the right iliac fossa, a fourth 5-mm port in the left midclavicular line 2 cm above the level of the umbilicus, and a last 5-mm port in the midline 4 cm above the pubic bone. Port sites for laparoscopic left colectomy. The tumor was localized by either visual inspection or intraoperative colonoscopy. The summit of sigmoid colon was then pulled anteriorly with a grasper toward |
|
Comparador activo: lateral approach
|
The patient was positioned in the modified lithotomy position with the main surgeon standing in between the abducted legs. The patient's head is lowered by 15° (Trendelenburg position), and table was 20° right-tilted. The position was adjusted at the time of splenic flexure mobilization to head elevation by 20° to let the small bowel go down toward the pelvis. Five ports were introduced [Figure 1]: a 10-mm port in the midline 4 cm above the umbilicus to increase the field of view, a second 5 mm port in the right midclavicular line just below the umbilicus, a third 10-12-mm port at the right midclavicular line in the right iliac fossa, a fourth 5-mm port in the left midclavicular line 2 cm above the level of the umbilicus, and a last 5-mm port in the midline 4 cm above the pubic bone. Port sites for laparoscopic left colectomy. The tumor was localized by either visual inspection or intraoperative colonoscopy. The summit of sigmoid colon was then pulled anteriorly with a grasper toward |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
evaluation of safety and effectiveness of inferior mesenteric artery first in combination with complete medial approach in splenic mobilization in left sided colorectal cancer .
Periodo de tiempo: 6 month
|
number of harvested lymph nodes
|
6 month
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- laparoscopic colorectal cancer
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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