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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03413930
Other study ID # RJ-TaTME-2018
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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