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

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Procedure: Transanal total mesorectal excision

• Registration Number: NCT02421432
• Lead Sponsor: National Cancer Center, Korea

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.

Study Timeline

• Study First Submitted: 2015-04-05
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-20
• Study Start: 2017-12-01
• Primary Completion: 2018-01-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-10
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transanal total mesorectal excision	Transanal total mesorectal excision	Laparoscopy-assisted transanal total mesorectal excision

Primary Outcome Measures

Name	Time	Method
TME quality & circumferential resection margin (CRM)	the day of surgery	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.

Secondary Outcome Measures

Name	Time	Method
30-day postoperative complications	1 month after surgery	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
Number of harvested Lymph Nodes	the day of surgery

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of