Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Single-center Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Total Mesorectal Excision in Rectal Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03413930
• Other study ID #: RJ-TaTME-2018
• Status: Withdrawn
• Phase: N/A
• Start date: June 2019
• Est. completion date: March 2026

Study information

• Verified date: February 2020
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision（LaTME）.

Description:

Colorectal cancer (CRC) including rectal cancer is one of the most common gastrointestinal tumors, and its incidence is third in the world. At present，surgical treatments is the main means to cure CRC. Total mesorectal excision (TME) is the gold standard for rectal cancer surgery. Transanal total mesorectal excision (TaTME) was recently developed to overcome technical difficulties associated with LaTME and open TME. Most reports are retrospective studies. More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TaTME for mid and low rectal cancer.This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 120 eligible patients will be randomly assigned to TaTME group and LaTME group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the oncological safety，efficacy and potential benefits of TaTME compared with LaTME for mid and low rectal cancer.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2026
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 years < age < 80 years

• Body mass index (BMI) <30 kg/m2

• Tumor located in mid and low rectum ( the lower border of the tumor is located distal to the peritoneal reflection)

• Pathological rectal carcinoma

• Clinically diagnosed cT1-3N0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history

• Tumor size of 5 cm or less

• ECOG score is 0-1

• ASA score is ?-?

• Informed consent

Exclusion Criteria:

• Requiring a Mile's procedure

• Fecal incontinence

• History of inflammatory bowel disease

• Pregnant woman or lactating woman

• Severe mental disease

• Intolerance of surgery for severe comorbidities

• Previous abdominal surgery

• Emergency operation due to complication (bleeding, perforation or obstruction) caused by rectal cancer

• Requirement of simultaneous surgery for other disease

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Transanal total mesorectal excision
Patients undergo transanal total mesorectal excision.(assisted by laparoscopy to control the IMA)
• Laparoscopic total mesorectal excision
Patients undergo Laparoscopic total mesorectal excision.

Locations

Country	Name	City	State
China	Ruijin Hospital North	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Deijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4. — View Citation

Fernández-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Díaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865. — View Citation

Simillis C, Hompes R, Penna M, Rasheed S, Tekkis PP. A systematic review of transanal total mesorectal excision: is this the future of rectal cancer surgery? Colorectal Dis. 2016 Jan;18(1):19-36. doi: 10.1111/codi.13151. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circumferential resection margin (CRM)	Positive rate of circumferential resection margin (pathological assessment)	14 days after surgery
Secondary	Completeness of mesorectum	Pathological assessment of completeness of the TME specimen(complete, near	14 days after surgery
Secondary	Lymph node detection	Lymph nodes harvested(numbers)	14 days after surgery
Secondary	Distal safety margin	Length of distal margin (millimeter,mm)	14 days after surgery
Secondary	Operative time	Operative time(minutes)	Intraoperative
Secondary	Intraoperative blood loss	Estimated blood loss(milliliters,ml)	Intraoperative
Secondary	Length of stay	Duration of hospital stay(days after surgery)	1-30 days after surgery
Secondary	Postoperative recovery course	Time to first ambulation, flatus, liquid diet and soft diet (hours after surgery)	1-14 days after surgery
Secondary	Early morbidity rate	Morbidity rate 30 days after surgery	30 days
Secondary	Pain score	Postoperative pain is recorded using the visual analog scale (VAS) pain score (0-10 points)tool on postoperative day 1, 2, 3 and the day of discharge	1-3 days after surgery
Secondary	3-year disease free survival rate	3-year disease free survival rate	36 months after surgery
Secondary	5-year overall survival rate	5-year overall survival rate	60 months after surgery