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

National Cancer Center, Korea49 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectal Cancer

Interventions

Transanal total mesorectal excisionPROCEDURE

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age: 20-80 years 2. biopsy-proven adenocarcinoma of the rectum 3. clinical staging (c or yc): T0-3, N0-2, M0 4. Rectal cancer located 3-12 cm from the anal verge 5. ECOG performance status: 2 or less 6. BMI: less than 30 Exclusion Criteria: 1. Synchronous colon cancer or other malignancy 2. Obstructing rectal cancer 3. Pregnant or breast-feeding 4. Receiving any other study agents 5. Fecal incontinence 6. History of prior colorectal cancer or inflammatory bowel disease 7. Tumor size: more than 7cm in long diameter 8. CRM: mesorectal fascia involvement or less than 1 mm on MRI

Locations (1)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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.

Time frame: the day of trananal TME

Secondary Outcomes

30-day postoperative complications

Time frame: 1 month after surgery

Number of harvested Lymph Nodes

Time frame: the day of surgery

Data from ClinicalTrials.gov

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