Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

February 12, 2020 updated by: Zhao Ren, Ruijin Hospital

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

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）.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201821
        • Ruijin Hospital North

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Study Chair: Yimei Jiang, MD, Ruijin Hospitla North

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJ-TaTME-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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