Rectal Cancer
Conditions
Keywords
trananal TME, safety, efficacy, difficult cases
Brief summary
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) 1. BMI: 30 or more 2. Tumor size: more than 7cm in long diameter 3. CRM: mesorectal fascia involvement or less than 1 mm on MRI
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.
Interventions
PROCEDURETransanal total mesorectal excision
Laparoscopy-assisted transanal total mesorectal excision
Sponsors
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
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 * If any one of the following (1 or 2 or 3) 1. BMI: 30 or more 2. Tumor size: more than 7cm in long diameter 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TME quality & circumferential resection margin (CRM) | the day of surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| 30-day postoperative complications | 1 month after surgery | 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 |
| Number of harvested Lymph Nodes | the day of surgery | — |
Other
| Measure | Time frame |
|---|---|
| 2-year local recurrence free survival | 2 years after surgery |
| 5-year overall survival | 5 years after surgery |
Countries
South Korea
Outcome results
None listed