Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal Total Mesorectal Excision
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- TME quality & circumferential resection margin (CRM)
Study Overview
Brief Summary
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
TME quality & circumferential resection margin (CRM)
Time Frame: the day of trananal TME
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.
Secondary Outcomes
- 30-day postoperative complications(1 month after surgery)
- Number of harvested Lymph Nodes(the day of surgery)
Investigators
Dae Kyung Sohn
MD., PHD, Center for Colorectal Cancer
National Cancer Center, Korea