NCT02406118

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

3.8 years

First QC Date

March 25, 2015

Last Update Submit

September 2, 2021

Conditions

Rectal Cancer

Keywords

transanal TME qualityCRM

Outcome Measures

Primary Outcomes (1)

  • TME quality & circumferential resection margin (CRM)

    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.

    the day of trananal TME

Secondary Outcomes (2)

  • 30-day postoperative complications

    1 month after surgery

  • Number of harvested Lymph Nodes

    the day of surgery

Other Outcomes (2)

  • 2-year local recurrence free survival

    2 years after surgery

  • 5-year overall survival

    5 years after surgery

Study Arms (1)

Transanal total mesorectal excision

EXPERIMENTAL

Laparoscopy-assisted transanal total mesorectal excision

Procedure: Transanal total mesorectal excision

Interventions

Transanal total mesorectal excisionPROCEDURE

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.

Also known as: Laparoscopy-assisted transanal TME
Transanal total mesorectal excision

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: 20-80 years
  • biopsy-proven adenocarcinoma of the rectum
  • clinical staging (c or yc): T0-3, N0-2, M0
  • Rectal cancer located 3-12 cm from the anal verge
  • ECOG performance status: 2 or less
  • BMI: less than 30

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
  • Tumor size: more than 7cm in long diameter
  • CRM: mesorectal fascia involvement or less than 1 mm on MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

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

Location

Related Publications (1)

  • Park SC, Sohn DK, Kim MJ, Chang HJ, Han KS, Hyun JH, Joo J, Oh JH. Phase II Clinical Trial to Evaluate the Efficacy of Transanal Endoscopic Total Mesorectal Excision for Rectal Cancer. Dis Colon Rectum. 2018 May;61(5):554-560. doi: 10.1097/DCR.0000000000001058.

    PMID: 29624549DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Dae Kyung Sohn

    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
MD., PHD, Center for Colorectal Cancer

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 2, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2022

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

KR(1)