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

NCT02421432 | Unknown DMC

• 1 other identifier: NCC2015-0050
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 1.BMI: 30 or more
2. 2.Tumor size: more than 7cm in long diameter
3. 3.CRM: mesorectal fascia involvement or less than 1 mm on MRI

Conditions

Rectal Cancer

Keywords

trananal TME; safety; efficacy; difficult cases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 30-day postoperative complications

  1 month after surgery

• Number of harvested Lymph Nodes

  the day of surgery

Other Outcomes (2)

• 2-year local recurrence free survival

  2 years after surgery

• 5-year overall survival

  5 years after surgery

Study Arms (1)

Transanal total mesorectal excision

EXPERIMENTAL

Laparoscopy-assisted transanal total mesorectal excision

Procedure: Transanal total mesorectal excision

Interventions

Transanal total mesorectal excision PROCEDURE

Laparoscopy-assisted transanal total mesorectal excision

Transanal total mesorectal excision

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Dae Kyung Sohn, MD, PHD

  Korea: National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., PHD.

Study Record Dates

• First Submitted: April 5, 2015
• First Posted: April 20, 2015
• Study Start: December 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2022
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

KR (1)