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

March 25, 2015 updated by: Jae Hwan Oh, National Cancer Center, Korea

A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision

The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Jae Hwan Oh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transanal total mesorectal excision
Laparoscopy-assisted transanal total mesorectal excision
Procedure: Transanal total mesorectal excision
Laparoscopy-assisted transanal total mesorectal excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day postoperative complications, No. of harvested LN
Time Frame: 1-5 years
1-5 years

Other Outcome Measures

Outcome Measure
Time Frame
Oncologic outcome(2-year local recurrence free survival, 5-year survival)
Time Frame: 1-5 years
1-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Jae Hwan Oh, MD, PHD, NCC,Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-TAME
  • NCC-1210170 (Other Grant/Funding Number: The National Cancer Center, South Korea)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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