Transanal Total Mesorectal Excision vs Robotic Total Mesorectal Excision (TaLaR03)
10 de junio de 2026 actualizado por: Yanhong Deng, Sun Yat-sen University
A Prospective, Randomized, Parallel-Controlled, Superiority Clinical Study Comparing Transanal Total Mesorectal Excision (taTME) and Robot-Assisted Total Mesorectal Excision (RTME) in the Treatment of Low Rectal Cancer
TME remains standard treatment for rectal cancer.
Both Robotic TME and taTME are innovative surgical techniques with potential advantages in low rectal cancer.
To date, no clinical studies have directly compared the conversion and complication rates between taTME and RTME in this population.
Therefore, the investigators propose to conduct a prospective, randomized, parallel-controlled clinical trial comparing taTME with RTME for low rectal cancer, aiming to provide high-level evidence for surgical decision-making and benefit more patients.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
Both RTME and taTME are innovative surgical techniques with potential advantages in low rectal cancer.
Intraoperative conversion rate is a key safety metric.
In low rectal cancer, changes in surgical approach not only affect resection outcomes but also sphincter preservation.To date, no clinical studies have directly compared the conversion and complication rates between taTME and RTME in this population.
Therefore, the investigators propose to conduct a prospective, randomized, parallel-controlled clinical trial comparing taTME with RTME for low rectal cancer, aiming to provide high-level evidence for surgical decision-making and benefit more patients.
The primary indicator in this study is intraoperative conversion rate.
Definition in each group as follows: During transanal total mesorectal excision (taTME), if the procedure cannot be completed due to difficulty in transanal operation, conversion to open abdominal surgery is required to complete TME resection, allowing better operative access, organ preservation, and tumor clearance.
During robot-assisted total mesorectal excision (rTME), if the transabdominal approach fails to achieve bowel transection or digestive reconstruction, conversion to transanal or open abdominal surgery is required to complete the procedure, ensuring operability, organ preservation, and tumor clearance.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
216
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Liang Kang, MD
- Número de teléfono: +8613602886833
- Correo electrónico: kangl@mail.sysu.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: Ling Shuang Luo, MD
- Número de teléfono: +8613751756175
- Correo electrónico: kangl@mail.sysu.edu.cn
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510655
- Reclutamiento
- The Sixth Affiliated Hospital of Sun Yat-sen University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:Newly diagnosed patients aged 18-75 years. Pathologically confirmed adenocarcinoma (tubular, papillary, mucinous, or signet-ring). Tumor ≤7 cm from anal verge (MRI or DRE). Clinical stage T1-T3, N+, M0 (AJCC 8th ed.), suitable for sphincter-preserving TME. ASA score I-III.
ECOG performance status 0-1. Informed consent obtained.
- Exclusion Criteria: Synchronous/metachronous colorectal cancers, local recurrence, or distant metastases. Bowel obstruction, perforation, bleeding requiring emergency surgery. Involvement of sphincter or adjacent organs requiring Inter-sphincter Resection (ISR). Poor preoperative anal function/incontinence. IBD or familial adenomatous polyposis (FAP).
Pregnancy or lactation. Severe psychiatric illness. Other malignancies within 5 years. Severe comorbidities or infections making surgery intolerable. Judged unsuitable by investigator.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
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Comparador activo: robotic TME
For patients with low rectal cancer, the da Vinci multi-arm robotic system is used to perform total mesorectal excision (TME).
The procedure includes vascular ligation, mesenteric mobilization, distal bowel transection beyond the tumor, and anastomosis, all completed transabdominally with robotic assistance.
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This study is designed to investigate the safety and superiority of transanal total mesorectal excision (taTME) in the treatment of rectal cancer compared with robot-assisted total mesorectal excision (rTME)
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Experimental: taTME
For patients with low rectal cancer, a combined transanal and transabdominal approach is used to complete the total mesorectal excision (TME).
A purse-string suture is placed approximately 1 cm below the distal tumor margin, followed by insertion of a single-port device.
The mesorectum is then mobilized from bottom to top.
Vascular ligation is performed laparoscopically via the abdominal approach.
The two teams (transanal and transabdominal) meet near the peritoneal reflection.
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This study is designed to investigate the safety and superiority of transanal total mesorectal excision (taTME) in the treatment of rectal cancer compared with robot-assisted total mesorectal excision (rTME)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intraoperative Conversion Rate
Periodo de tiempo: at the end of operation
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During transanal total mesorectal excision (TaTME), if the procedure cannot be completed due to difficulty in transanal operation, conversion to open abdominal surgery is required to complete TME resection, allowing better operative access, organ preservation, and tumor clearance. During robot-assisted total mesorectal excision (rTME), if the transabdominal approach fails to achieve bowel transection or digestive reconstruction, conversion to transanal or open abdominal surgery is required to complete the procedure, ensuring operability, organ preservation, and tumor clearance. |
at the end of operation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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3-year disease-free survival (DFS)
Periodo de tiempo: three years after the operation
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3-Year DFS (Disease-Free Survival) refers to the proportion of patients who remain alive and free from any signs or recurrence of the disease for three years following surgical removal of the primary tumor.
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three years after the operation
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3-Year OS
Periodo de tiempo: 3 years after the operation
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3-Year OS (Overall Survival) refers to the percentage of patients who remain alive for three years following a surgical procedure, regardless of the cause of death or the status of the disease.
The survival time is typically calculated from the date of surgery to the date of death from any cause.
Patients who are alive at the three-year mark-whether they are disease-free, have experienced a recurrence, or are receiving other treatments-are counted as survivors
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3 years after the operation
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operative time
Periodo de tiempo: 1 day after the operation
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Operative time refers to the total duration measured from the initial surgical incision to the completion of wound closure.
It typically includes all intraoperative procedures, such as dissection, resection (e.g., tumor removal), reconstruction, hemostasis, and placement of drains or implants, but excludes anesthesia induction, positioning, prepping, draping, and recovery room time
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1 day after the operation
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Liang Kang, Sixth Affiliated Hospital, Sun Yat-sen University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Liu H, Zeng Z, Zhang H, Wu M, Ma D, Wang Q, Xie M, Xu Q, Ouyang J, Xiao Y, Song Y, Feng B, Xu Q, Wang Y, Zhang Y, Hao Y, Luo S, Zhang X, Yang Z, Peng J, Wu X, Ren D, Huang M, Lan P, Tong W, Ren M, Wang J, Kang L; Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group. Morbidity, Mortality, and Pathologic Outcomes of Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer Short-term Outcomes From a Multicenter Randomized Controlled Trial. Ann Surg. 2023 Jan 1;277(1):1-6. doi: 10.1097/SLA.0000000000005523. Epub 2022 Jul 11.
- Jiang W, Xu J, Cui M, Qiu H, Wang Z, Kang L, Deng H, Chen W, Zhang Q, Du X, Yang C, Guo Y, Zhong M, Ye K, You J, Xu D, Li X, Xiong Z, Tao K, Ding K, Zang W, Feng Y, Pan Z, Wu A, Huang F, Huang Y, Wei Y, Su X, Chi P; LASRE trial investigators. Laparoscopy-assisted versus open surgery for low rectal cancer (LASRE): 3-year survival outcomes of a multicentre, randomised, controlled, non-inferiority trial. Lancet Gastroenterol Hepatol. 2025 Jan;10(1):34-43. doi: 10.1016/S2468-1253(24)00273-5. Epub 2024 Nov 8.
- Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Liang F, He G, Wei Y, Xu J; REAL Study Group. Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): short-term outcomes of a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):991-1004. doi: 10.1016/S2468-1253(22)00248-5. Epub 2022 Sep 8.
- Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Wei Y, Liang F, He G, Xu J; REAL Study Group. Robotic vs Laparoscopic Surgery for Middle and Low Rectal Cancer: The REAL Randomized Clinical Trial. JAMA. 2025 Jul 8;334(2):136-148. doi: 10.1001/jama.2025.8123.
- Zeng Z, Luo S, Zhang H, Wu M, Ma D, Wang Q, Xie M, Xu Q, Ouyang J, Xiao Y, Song Y, Feng B, Xu Q, Wang Y, Zhang Y, Shi L, Ling L, Zhang X, Huang L, Yang Z, Peng J, Wu X, Ren D, Huang M, Lan P, Wang J, Tong W, Ren M, Liu H, Kang L; Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group. Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer: The TaLaR Randomized Clinical Trial. JAMA. 2025 Mar 4;333(9):774-783. doi: 10.1001/jama.2024.24276.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de junio de 2025
Finalización primaria (Estimado)
28 de abril de 2027
Finalización del estudio (Estimado)
28 de abril de 2029
Fechas de registro del estudio
Enviado por primera vez
24 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2026
Publicado por primera vez (Actual)
16 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025ZSLYEC-104
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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