Evaluation of the Safety and the Efficacy of Transanal TME in Difficult Cases

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 in difficult case. Difficult case is defined as below; - If any one of the following (1 or 2 or 3) BMI: 30 or more Tumor size: more than 7cm in long diameter CRM: mesorectal fascia involvement or less than 1 mm on MRI

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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A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision in Difficult Cases of Laparoscopic Surgery for Rectal Cancer

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 If any one of the following (1 or 2 or 3) BMI: 30 or more Tumor size: more than 7cm in long diameter CRM: mesorectal fascia involvement or less than 1 mm on MRI 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

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>* Laparoscopy-assisted transanal total mesorectal excision<br>|

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 surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day postoperative complications | The Clavien-Dindo Classification of Surgical Complications. Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III: : Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management. Grade V: Death of a patient | 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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trananal TME, safety, efficacy, difficult cases