Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort

Transanal Versus Laparoscopic Total Mesorectal Excision: a Prospective Observational Cohort

The purpose of this study was to compare the long-term oncology outcomes and specimen quality of taTME and laTME in the treatment of middle and low rectal cancer by a large sample cohort. At the same time, the local recurrence following a primary rectal cancer resection was analyzed to respond to the concerns about the event of the national suspension for TaTME due to the high local recurrence rate in Norway.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: transanal total mesorectal excision

Detailed Description

Laparoscopic surgery is considered to have better visualization for more accurate separation and further injury reduction than open surgery. However, the oncology outcomes are still controversial. Especially in the challenging patients who have narrow and deep pelvic, the disadvantage that it is difficult to obtain high-quality resected specimens during laparoscopic TME (laTME) surgery is considered to be magnified. It is considered transanal total mesorectal excision (taTME) is an alternative method to solve this "old problem". However, as a new technology that has been around for only 10 years, the applicability of taTME worldwide needs to be further proved in long-term oncology. This prospective cohort study aimed to compare taTME surgery to laTME surgery for mid and low-rectal cancer on long-term oncology outcomes from a single, experienced Chinese center that was an early adopter of taTME.

• Study Type: Observational
• Enrollment (Actual): 2502

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Low-mid rectal cancer within Stage III.

Description

Inclusion Criteria:

1. Age between 18 and 80 years old
2. Confirmed rectal adenocarcinoma cancer pathologically
3. Tumor location ≦ 12 cm from the anal margin
4. Willing and able to provide written informed consent for participation in this study

Exclusion Criteria:

1. Distant metastasis before surgery
2. More than one colorectal tumor at diagnosis
3. Familial adenomatous polyposis
4. Recurrent rectal cancer
5. Undergo transanal minimally invasive surgery
6. Undergo palliative treatment
7. Undergo emergency surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
taTME; patients who underwent transanal total mesorectal excision	Procedure: transanal total mesorectal excision; transanal TME; Other Names: laparoscopic total mesorectal excision
laTME; patients who underwent laparoscopic total mesorectal excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival rate	5 years after the surgery
disease-free survival ratev	5 years after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local recurrence rate	Local recurrence was defined as radiologic or histopathologic evidence of any recurrent disease deposit located in the pelvis in the prior area of dissection following a primary rectal cancer resection, with or without distal metastasis	3 years after the surgery
Cancer special survival rate	Cancer special survival was defined as the time from the date of primary rectal cancer resection to the date of death caused by rectal cancer.	5 years after the surgery
Quality of the mesorectum specimen	The quality of the resected mesorectum was classified into three grades: (a) incomplete, (b) nearly complete, and (c) complete	30 days after the surgery
CRM status	The CRM was regarded as positive if the tumor distance or malignant lymph node to CRM was ≦1 mm.	30 days after the surgery
DRM status	The DRM was regarded as positive if it was microscopically involved by or ≦1 mm from the tumor margins.	30 days after the surgery

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Liang Kang, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Rectal cancer; taTME; Local recurrence
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: GIHSYSU-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The data can be obtained with a proper request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No