Robotic Assisted Transanal Total Mesorectal Excision Surgery for Rectal Cancer in Low Site

Army Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2

Conditions: Rectal Neoplasms

Treatments: Procedure: R-TME; Procedure: R-TaTME

Study type: Interventional

Funder types: Other

Identifiers

NCT03422835

RATERAL-01

Details and patient eligibility

About

To investigates the feasibility, practicability, safety and subjective as well as functional outcome of Robotic transanal total mesentery excision for rectal cancer in low site.

Full description

Transanal total mesorectal excision (TaTME) may offer a better way to achieve radical resection and functional protection for lower rectal cancer, which have been regarded as challenging situations in rectal cancer surgery. However, the narrow angle and limited space of the operation restrict the wide spread of this technique. Da Vinci robotic system has achieved good results in rectal cancer surgery. Robotics may help to overcome technical difficulties in TaTME. The purpose of this study was to explore the availability of Da Vinci robotic-assisted transanal total mesorectal excision(R-TaTME) This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of Robotic transanal total mesentery excision for rectal cancer in low site.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adenocarcinoma of the rectum by biopsy
• the lower edge of the tumor from the anal margin less than 8cm according to MRI or rigid endoscopy
• tumor diameter less than 4cm
• baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)
• tolerable to surgery
• be able to understand and willing to participate in this trial with signature

Exclusion criteria

• history of malignant colorectal neoplasia
• recent diagnosis with other malignancies
• patients requiring emergency surgery such as obstruction，perforation and bleeding
• tumor involving adjacent organs, anal sphincter, or levator ani muscle muti-focal colorectal cancer
• preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence history of inflammatory bowel disease or familial adenomatous polyposis
• participating in other clinical trails
• History of pelvic radiation
• BMI > 40
• Large uterine fibroids
• can not tolerate the surgery
• history of serious mental illness
• pregnancy or lactating women
• preoperative uncontrolled infection
• the researchers believe the patients should not enrolled in

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

R-TME

Active Comparator group

Description:

Robotic total mesentery excision surgery for rectal cancer.

Treatment:

Procedure: R-TME

R-TaTME

Experimental group

Description:

Robotic transanal total mesentery excision surgery for rectal cancer.

Treatment:

Procedure: R-TaTME