Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: transanal total mesorectal excision

• Registration Number: NCT05682794
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

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 Timeline

• Study Start: 2014-01
• Primary Completion: 2022-10
• Study Completion: 2022-10
• Status Verified: 2022-12
• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2022-12-27
• Last Update Submitted: 2022-12-27
• Study First Posted: 2023-01-12
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2502

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
taTME	transanal total mesorectal excision	patients who underwent transanal total mesorectal excision

Primary Outcome Measures

Name	Time	Method
disease-free survival ratev	5 years after the surgery
Overall survival rate	5 years after the surgery

Secondary Outcome Measures

Name	Time	Method
Cancer special survival rate	5 years after the surgery	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.
CRM status	30 days after the surgery	The CRM was regarded as positive if the tumor distance or malignant lymph node to CRM was ≦1 mm.
DRM status	30 days after the surgery	The DRM was regarded as positive if it was microscopically involved by or ≦1 mm from the tumor margins.
Quality of the mesorectum specimen	30 days after the surgery	The quality of the resected mesorectum was classified into three grades: (a) incomplete, (b) nearly complete, and (c) complete
Local recurrence rate	3 years after the surgery	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