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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02421432
• Other study ID #: NCC2015-0050
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2021
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 1, 2022
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Transanal total mesorectal excision
Laparoscopy-assisted transanal total mesorectal excision

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	2-year local recurrence free survival		2 years after surgery
Other	5-year overall survival		5 years after surgery
Primary	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	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
Secondary	Number of harvested Lymph Nodes		the day of surgery