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The Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer

16 de diciembre de 2016 actualizado por: Yanhong Deng, Sun Yat-sen University

A Pilot Study of the Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer Without Conventional Laparoscopic Assistance

During the past three years, a revolutionized radical surgical approach for rectal cancer ("down to up TME " approach or "transanal TME (TaTME)"approach, which is opposite to the conventional approach) has emerged and it is a concept that combines natural orifice transluminal endoscopic surgery(NOTES) and total mesorectal excision(TME) with curative intent. The feasibility, safety and reproducibility of it were first demonstrated in swine survival experiments and subsequently in human cadaver series, and then it was successfully applied to human patients in few centers around the world, most of which were performed with assistance of laparoscopy, namely hybrid transanal TME. In addition, pure-NOTES without conventional laparoscopic assistance (no scar) has also been demonstrated, though the cases were more limited. In the initial stage, our group has successfully performed this no-scar transanal TME in a series of human cadavers with satisfactory outcome. Hence the investigators conduct this study, looking to see if this pure transanal NOTES investigational procedure is a safe and effective approach to radically remove rectal cancer of the mid and lower rectum and meanwhile, if it can reduce pain, gain faster recovery and better function and life quality when gaining the best cosmetic effect.

Descripción general del estudio

Descripción detallada

Transanal total mesorectal excision (TaTME) is a novel development in the field of colorectal surgery which combines the mini-invasive concept of natural orifice transluminal endoscopic surgery(NOTES), the technique of single-port laparoscopic surgery and the principle of total mesorectal excision with curative intent for treating rectal cancer. Based on the platform of either transanal endoscopic microsurgery(TEM) or transanal minimally invasive surgery (TAMIS), it is an innovative way of retrograde TME dissection from bottom to up with or without laparoscopic assistance. It is supposed to facilitate distal rectal mobilization, thus achieving precise and sufficient distal margin and to reduced need for multiple stapler firings in transecting the rectum, consequently decreasing anastomotic leakage rates which is especially important for obese male patients with a narrow pelvis where exposure to the distal rectum from the abdominal approach can prove difficult. It could also protect neurovascular bundle with better visualization and exposure and has the advantage of better function and avoiding sacrificing sphincter. After a series of preclinical trail of animal and cadaver, it has been successfully applied to humans and successional reports have proved its feasibility and safety. However, the majority of published series is hybrid NOTES, which need the assistance of conventional laparoscopic surgery from above to bottom and abdominal incision, scar, pain and incision related complications such as wound infection, abscess, hernia and implanted incisional tumors cannot be necessary avoided. It is also worried that the cost will increased since two groups of surgical equipment are needed(the abdominal and perineal) and more surgical staff are required if the two team operate at the same time(two-team approach). Up to date, as far as we have known, the pure transanal TME NOTES without any laparoscopic assistance has also been successfully performed in human patients though the cases are rare. The investigators of our center have also successfully performed pure-NOTES rectal resection in human cadavers in the past few months, and are confident to move this forward to conduct this pilot study to evaluate the feasibility and safety of this surgery in rectal cancer patients.

Tipo de estudio

Intervencionista

Inscripción (Actual)

20

Fase

  • Fase 2
  • Fase 1

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.

Ubicaciones de estudio

    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510655
        • Gastrointestinal Hospital, Sun Yatsen University

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

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Biopsy-proven adenocarcinoma of the rectum
  • No previous abdominal surgery, no distant metastasis or synchronous colon cancer
  • BMI≤ 35kg/m2
  • Clinical staging (T1 or T2 or T3) with N1-2M0
  • Patients of rectal adenocarcinoma with T3N0 or N (+) received preoperative concurrent chemoradiotherapy (CCRT) as neoadjuvant therapy
  • Rectal cancer located 4-12 cm from the anal verge
  • The diameter of primary tumor should <6cm
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • American Society of Anesthesiology (ASA) classⅠ to Ⅲ lesions
  • After the evaluation of Multi-disciplinary team (MDT)
  • Written informed consent

Exclusion Criteria:

  • T4 tumor that invade the external sphincter or levator ani muscle or neighbor organs
  • Recurrent rectal cancer
  • Distant metastasis
  • Obstructing rectal cancer
  • Synchronous colon cancer
  • Pregnant or breast-feeding women
  • Fecal incontinence
  • History of prior colorectal cancer
  • History of inflammatory bowel disease
  • Other malignancies diagnosed within the previous year
  • Mental illness
  • Any evidence of active infection
  • History of bleeding diathesis or coagulopathy
  • Impaired renal or hepatic function that could not tolerate surgery

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: no-scar transanal TME
no-scar transanal total mesorectal excision(TME) of rectal cancer
Otros nombres:
  • Pure NOTES transanal TME
  • TaTME
  • TAMIS TME
  • single-port transanal TME

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Composite mesure of prioperative feasibility and safety
Periodo de tiempo: one-year
To evaluate the feasibility and safety by operative time, estimated blood loss, intraoperative complications, convert to Hybrid NOTES or open surgery, pathological outcome including Total Mesorectal Excision (TME) quality, the lymph nodes harvested, and specimen length, circumferential margin, etc. and postoperative complications graded according to Clavien-Dindo, reoperation rate, 30-day mortality, 30-day readmission
one-year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
composite measure of life quality
Periodo de tiempo: 1-3 year
To evaluate bladder function, anal function, sexual function and life quality by incontinence score, EORTC QLQ C30 and EORTC QLQ CR38, etc
1-3 year
Composite mesure of postoperative outcome
Periodo de tiempo: one-year
To evaluate the postoperative outcome by length of hospital stay after operation, the time of first flatus, the time of recover to flow diet, postoperative pain by VAS, analgesic use ,etc
one-year
Composite mesure of oncological outcome
Periodo de tiempo: 1-3 year
3-year disease free survival (DFS), 3-year local recurrence rate, 3-year distal metastasis rate, 3-year overall survival (cancer related or non-cancer related)
1-3 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: Jianping Wang, MD, Sun Yatsen 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.

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

1 de septiembre de 2014

Finalización primaria (Actual)

1 de diciembre de 2015

Finalización del estudio (Actual)

1 de junio de 2016

Fechas de registro del estudio

Enviado por primera vez

4 de septiembre de 2014

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2014

Publicado por primera vez (Estimar)

11 de septiembre de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

19 de diciembre de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

16 de diciembre de 2016

Última verificación

1 de septiembre de 2014

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Cáncer de recto

Ensayos clínicos sobre no-scar transanal total mesorectal excision(TME)

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