search
Back to results

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

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transanal total mesorectal excision
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Neoplasms, Colorectal Neoplasms, transanal surgery

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jae Hwan Oh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transanal total mesorectal excision

Arm Description

Laparoscopy-assisted transanal total mesorectal excision

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

30-day postoperative complications, No. of harvested LN

Full Information

First Posted
September 4, 2013
Last Updated
March 25, 2015
Sponsor
National Cancer Center, Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT01938027
Brief Title
The Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision
Official Title
A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal Neoplasms, Colorectal Neoplasms, transanal surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transanal total mesorectal excision
Arm Type
Experimental
Arm Description
Laparoscopy-assisted transanal total mesorectal excision
Intervention Type
Procedure
Intervention Name(s)
Transanal total mesorectal excision
Intervention Description
Laparoscopy-assisted transanal total mesorectal excision
Primary Outcome Measure Information:
Title
Total Mesorectal Excision(TME) quality
Description
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.
Time Frame
1-5 years
Secondary Outcome Measure Information:
Title
30-day postoperative complications, No. of harvested LN
Time Frame
1-5 years
Other Pre-specified Outcome Measures:
Title
Oncologic outcome(2-year local recurrence free survival, 5-year survival)
Time Frame
1-5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Hwan Oh, MD, PHD
Organizational Affiliation
NCC,Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jae Hwan Oh
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27757396
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs