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

NCT ID: NCT02421432

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2022-12-01

Brief 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

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transanal total mesorectal excision

Laparoscopy-assisted transanal total mesorectal excision

Group Type: EXPERIMENTAL

Transanal total mesorectal excision

Intervention Type: PROCEDURE

Laparoscopy-assisted transanal total mesorectal excision

Interventions

Transanal total mesorectal excision

Laparoscopy-assisted transanal total mesorectal excision

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dae Kyung Sohn

MD., PHD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dae Kyung Sohn, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Korea: National Cancer Center

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCC2015-0050

Identifier Type: -

Identifier Source: org_study_id