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Completed

NCT Number: NCT01938027

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.

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Key information

Conditions

Rectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jae Hwan Oh

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transanal total mesorectal excision

Procedure

Laparoscopy-assisted transanal total mesorectal excision

Primary outcomes

  1. 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.

Secondary outcomes

  1. 30-day postoperative complications, No. of harvested LN

    Time frame: 1-5 years

Other outcomes

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

    Time frame: 1-5 years

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2013
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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