A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- National Cancer Center, Korea
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Total Mesorectal Excision(TME) quality
- Status
- Completed
- Last Updated
- 11 years ago
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.
Investigators
Jae Hwan Oh
Head of Center for Colorectal Cancer, National Cancer Center
National Cancer Center, Korea
Eligibility Criteria
Inclusion Criteria
- •age: 20-80 years
- •biopsy-proven adenocarcinoma of the rectum
- •clinical staging, (T1 or T2 or T3) with N0M0
- •Rectal cancer located 4-12 cm from the anal verge
- •ECOG performance status 2 or less
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
- •BMI \> 30
- •T3 rectal cancer not treated preoperatively with full-course chemoradiation
Outcomes
Primary Outcomes
Total Mesorectal Excision(TME) quality
Time Frame: 1-5 years
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, No. of harvested LN(1-5 years)