Evaluation of the Safety and the Efficacy of Transanal TME in Difficult Cases

A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision in Difficult Cases of Laparoscopic Surgery for Rectal Cancer

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

Difficult case is defined as below;

- If any one of the following (1 or 2 or 3)

1. BMI: 30 or more
2. Tumor size: more than 7cm in long diameter
3. CRM: mesorectal fascia involvement or less than 1 mm on MRI

Study Overview

• Status: Active, not recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
      • National Cancer Center

Participation Criteria

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 (c or yc): T0-3, N0-2, M0
• Rectal cancer located 3-12 cm from the anal verge
• ECOG performance status: 2 or less

• If any one of the following (1 or 2 or 3)

  1. BMI: 30 or more
  2. Tumor size: more than 7cm in long diameter
  3. CRM: mesorectal fascia involvement or less than 1 mm on MRI

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

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
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 surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day postoperative complications	The Clavien-Dindo Classification of Surgical Complications. Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III: : Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management. Grade V: Death of a patient	1 month after surgery
Number of harvested Lymph Nodes		the day of surgery

Other Outcome Measures

Outcome Measure	Time Frame
5-year overall survival	5 years after surgery
2-year local recurrence free survival	2 years after surgery

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Investigators: Principal Investigator: Dae Kyung Sohn, MD, PHD, Korea: National Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 5, 2015
• First Submitted That Met QC Criteria: April 15, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: safety; efficacy; trananal TME; difficult cases
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: NCC2015-0050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No