Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal TME

Study Overview
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Brief Summary
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The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.

Detailed Description
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Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Official Title
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Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal Total Mesorectal Excision

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: 20-80 years biopsy-proven adenocarcinoma of the rectum clinical staging (c or yc): T0-3, N0-2, M0 Rectal cancer located 3-12 cm from the anal verge ECOG performance status: 2 or less BMI: less than 30 Exclusion Criteria: Synchronous colon cancer or other malignancy Obstructing rectal cancer Pregnant or breast-feeding Receiving any other study agents Fecal incontinence History of prior colorectal cancer or inflammatory bowel disease Tumor size: more than 7cm in long diameter CRM: mesorectal fascia involvement or less than 1 mm on MRI

Ages Eligible for Study
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Minimum Age: 20 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transanal total mesorectal excision<br>Laparoscopy-assisted transanal total mesorectal excision | Procedure: Transanal total mesorectal excision<br>* Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.<br>* Other names: Laparoscopy-assisted transanal TME;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TME quality & circumferential resection margin (CRM) | The quality of the mesorectum was determined using pathology reports and scored using three grades: Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing. Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles. Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin. | the day of trananal TME | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day postoperative complications |  | 1 month after surgery | 
| Number of harvested Lymph Nodes |  | the day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transanal TME quality, CRM