The Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision

NCT01938027 | Completed DMC

• 2 other identifiers: NCC-TAMENCC-1210170
• 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.

Conditions

Rectal Cancer

Keywords

Rectal Neoplasms; Colorectal Neoplasms; transanal surgery

Outcome Measures

Primary Outcomes (1)

• Total Mesorectal Excision(TME) quality

  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.

  1-5 years

Secondary Outcomes (1)

• 30-day postoperative complications, No. of harvested LN

  1-5 years

Other Outcomes (1)

• Oncologic outcome(2-year local recurrence free survival, 5-year survival)

  1-5 years

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, (T1 or T2 or T3) with N0M0
• Rectal cancer located 4-12 cm from the anal verge
• ECOG performance status 2 or less

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
• BMI \> 30
• T3 rectal cancer not treated preoperatively with full-course chemoradiation

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

Jae Hwan Oh

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

Location

Related Publications (1)

• Oh JH, Park SC, Kim MJ, Park BK, Hyun JH, Chang HJ, Han KS, Sohn DK. Feasibility of transanal endoscopic total mesorectal excision for rectal cancer: results of a pilot study. Ann Surg Treat Res. 2016 Oct;91(4):187-194. doi: 10.4174/astr.2016.91.4.187. Epub 2016 Sep 30.

  PMID: 27757396 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jae Hwan Oh, MD, PHD

  NCC,Korea

  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: Head of Center for Colorectal Cancer, National Cancer Center

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 10, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

KR (1)