Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

Shanghai Jiao Tong University

Status: Withdrawn

Conditions: Rectal Cancer

Treatments: Procedure: Transanal total mesorectal excision; Procedure: Laparoscopic total mesorectal excision

Study type: Interventional

Funder types: Other

Identifiers

NCT03413930

RJ-TaTME-2018

Details and patient eligibility

About

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）.

Full description

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

TaTME

Experimental group

Description:

Patients with mid or low rectal cancer undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA）

Treatment:

Procedure: Transanal total mesorectal excision

LaTME

Active Comparator group

Description:

Patients with mid or low rectal cancer undergo laparoscopic total mesorectal excision.

Treatment:

Procedure: Laparoscopic total mesorectal excision