Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal TME

Rectal Cancer Clinical Trial

Official title:

Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal Total Mesorectal Excision

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02406118
• Other study ID #: NCC2015-0033
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2015
• 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.

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: 49
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. age: 20-80 years

2. biopsy-proven adenocarcinoma of the rectum

3. clinical staging (c or yc): T0-3, N0-2, M0

4. Rectal cancer located 3-12 cm from the anal verge

5. ECOG performance status: 2 or less

6. BMI: less than 30

Exclusion Criteria:

1. Synchronous colon cancer or other malignancy

2. Obstructing rectal cancer

3. Pregnant or breast-feeding

4. Receiving any other study agents

5. Fecal incontinence

6. History of prior colorectal cancer or inflammatory bowel disease

7. Tumor size: more than 7cm in long diameter

8. CRM: mesorectal fascia involvement or less than 1 mm on MRI

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Transanal total mesorectal excision
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.

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 trananal TME
Secondary	30-day postoperative complications		1 month after surgery
Secondary	Number of harvested Lymph Nodes		the day of surgery