Clinical trial NCT03413930: Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer
Official title: Single-center Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Total Mesorectal Excision in Rectal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rectal Cancer
Keywords: TaTME
Rectal cancer
Laparoscopic Surgery
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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）.

Detailed 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.

Eligibility criteria: 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 Ⅰ-Ⅲ
* 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

Primary outcomes:
measure: Circumferential resection margin (CRM)
timeFrame: 14 days after surgery
Secondary outcomes:
measure: Completeness of mesorectum
timeFrame: 14 days after surgery
measure: Lymph node detection
timeFrame: 14 days after surgery
measure: Distal safety margin
timeFrame: 14 days after surgery
measure: Operative time
timeFrame: Intraoperative
measure: Intraoperative blood loss
timeFrame: Intraoperative
measure: Length of stay
timeFrame: 1-30 days after surgery
measure: Postoperative recovery course
timeFrame: 1-14 days after surgery
measure: Early morbidity rate
timeFrame: 30 days
measure: Pain score
timeFrame: 1-3 days after surgery
measure: 3-year disease free survival rate
timeFrame: 36 months after surgery
measure: 5-year overall survival rate
timeFrame: 60 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital North
state: Shanghai
Study officials:
affiliation: Ruijin Hospitla North
name: Yimei Jiang, MD
role: STUDY_CHAIR
References:
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.
citation: Fernandez-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Diaz 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.
citation: 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.