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

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ClinicalTrials.gov Identifier: NCT01938027
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Jae Hwan Oh, National Cancer Center, Korea

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

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Transanal total mesorectal excision Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision
Study Start Date : September 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. 30-day postoperative complications, No. of harvested LN [ Time Frame: 1-5 years ]

Other Outcome Measures:
  1. Oncologic outcome(2-year local recurrence free survival, 5-year survival) [ Time Frame: 1-5 years ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938027


Locations
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Korea, Republic of
Jae Hwan Oh
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
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Principal Investigator: Jae Hwan Oh, MD, PHD NCC,Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jae Hwan Oh, Head of Center for Colorectal Cancer, National Cancer Center, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01938027     History of Changes
Other Study ID Numbers: NCC-TAME
NCC-1210170 ( Other Grant/Funding Number: The National Cancer Center, South Korea )
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Jae Hwan Oh, National Cancer Center, Korea:
Rectal Neoplasms
Colorectal Neoplasms
transanal surgery

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases