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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
A Prospective Cohort Study of Robotic Transanal Total Mesentery Excision Versus Conventional Robotic Surgery for Rectal Cancer in Low Site

Conditions
-----------------
Rectal Neoplasms

Intervention / Treatment
-----------------
* Procedure: R-TME
* Procedure: R-TaTME


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: R-TME<br>Robotic total mesentery excision surgery for rectal cancer. | Procedure: R-TME<br>* Conventional Robotic Total Mesentery Excision<br>|
| Experimental: R-TaTME<br>Robotic transanal total mesentery excision surgery for rectal cancer. | Procedure: R-TaTME<br>* Robotic Transanal Total Mesentery Excision<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive rate of circumferential resection margin (CRM) of the specimens | Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while >1mm is negative. | 10 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The grade score of the specimens integrity | the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see >5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3. | 10 days after surgery | 
| The distance between lower tumor margin and the lower reaction margin | the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin. | 10 days after surgery | 
| postoperative hospital stay | recovery information. | 3 years after surgery | 
| disease free survival rate | the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not. | 3 years after surgery | 
| overall survival rate | the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not. | 3 years after surgery | 
| the rate of postoperative complications | preoperative safety containing operation information, complication information. | 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transanal surgery, robotic surgery, total mesorectal excision