Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

Study Overview
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Brief Summary
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This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision（LaTME）.

Detailed Description
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Colorectal cancer (CRC) including rectal cancer is one of the most common gastrointestinal tumors, and its incidence is third in the world. At present，surgical treatments is the main means to cure CRC. Total mesorectal excision (TME) is the gold standard for rectal cancer surgery. Transanal total mesorectal excision (TaTME) was recently developed to overcome technical difficulties associated with LaTME and open TME. Most reports are retrospective studies. More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TaTME for mid and low rectal cancer.This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 120 eligible patients will be randomly assigned to TaTME group and LaTME group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the oncological safety，efficacy and potential benefits of TaTME compared with LaTME for mid and low rectal cancer.

Official Title
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Single-center Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Total Mesorectal Excision in Rectal Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Transanal total mesorectal excision
* Procedure: Laparoscopic total mesorectal excision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years < age < 80 years Body mass index (BMI) <30 kg/m2 Tumor located in mid and low rectum ( the lower border of the tumor is located distal to the peritoneal reflection) Pathological rectal carcinoma Clinically diagnosed cT1-3N0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history Tumor size of 5 cm or less ECOG score is 0-1 ASA score is Ⅰ-Ⅲ Informed consent Exclusion Criteria: Requiring a Mile's procedure Fecal incontinence History of inflammatory bowel disease Pregnant woman or lactating woman Severe mental disease Intolerance of surgery for severe comorbidities Previous abdominal surgery Emergency operation due to complication (bleeding, perforation or obstruction) caused by rectal cancer Requirement of simultaneous surgery for other disease

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TaTME<br>Patients with mid or low rectal cancer undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA） | Procedure: Transanal total mesorectal excision<br>* Patients undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA）<br>|
| Active Comparator: LaTME<br>Patients with mid or low rectal cancer undergo laparoscopic total mesorectal excision. | Procedure: Laparoscopic total mesorectal excision<br>* Patients undergo Laparoscopic total mesorectal excision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circumferential resection margin (CRM) | Positive rate of circumferential resection margin (pathological assessment) | 14 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completeness of mesorectum | Pathological assessment of completeness of the TME specimen（complete, near | 14 days after surgery | 
| Lymph node detection | Lymph nodes harvested（numbers） | 14 days after surgery | 
| Distal safety margin | Length of distal margin （millimeter，mm） | 14 days after surgery | 
| Operative time | Operative time（minutes） | Intraoperative | 
| Intraoperative blood loss | Estimated blood loss（milliliters，ml） | Intraoperative | 
| Length of stay | Duration of hospital stay（days after surgery） | 1-30 days after surgery | 
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery） | 1-14 days after surgery | 
| Early morbidity rate | Morbidity rate 30 days after surgery | 30 days | 
| Pain score | Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge | 1-3 days after surgery | 
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months after surgery | 
| 5-year overall survival rate | 5-year overall survival rate | 60 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TaTME, Rectal cancer, Laparoscopic Surgery