Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transanal Versus Laparoscopic Total Mesorectal Excision: a Prospective Observational Cohort

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: transanal total mesorectal excision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 80 years old Confirmed rectal adenocarcinoma cancer pathologically Tumor location ≦ 12 cm from the anal margin Willing and able to provide written informed consent for participation in this study Exclusion Criteria: Distant metastasis before surgery More than one colorectal tumor at diagnosis Familial adenomatous polyposis Recurrent rectal cancer Undergo transanal minimally invasive surgery Undergo palliative treatment Undergo emergency surgery

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| taTME<br>patients who underwent transanal total mesorectal excision | Procedure: transanal total mesorectal excision<br>* transanal TME<br>* Other names: laparoscopic total mesorectal excision;|
| laTME<br>patients who underwent laparoscopic total mesorectal excision | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer, taTME, Local recurrence