Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer
- Conditions
- Rectal Cancer
- Interventions
- Procedure: Laparoscopic total mesorectal excisionProcedure: Transanal total mesorectal excision
- Registration Number
- NCT03413930
- Lead Sponsor
- Ruijin Hospital
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LaTME Laparoscopic total mesorectal excision Patients with mid or low rectal cancer undergo laparoscopic total mesorectal excision. TaTME Transanal total mesorectal excision Patients with mid or low rectal cancer undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA）
- Primary Outcome Measures
Name Time Method Circumferential resection margin (CRM) 14 days after surgery Positive rate of circumferential resection margin (pathological assessment)
- Secondary Outcome Measures
Name Time Method Completeness of mesorectum 14 days after surgery Pathological assessment of completeness of the TME specimen（complete, near
Lymph node detection 14 days after surgery Lymph nodes harvested（numbers）
Distal safety margin 14 days after surgery Length of distal margin （millimeter，mm）
Operative time Intraoperative Operative time（minutes）
Intraoperative blood loss Intraoperative Estimated blood loss（milliliters，ml）
Length of stay 1-30 days after surgery Duration of hospital stay（days after surgery）
Postoperative recovery course 1-14 days after surgery Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）
Early morbidity rate 30 days Morbidity rate 30 days after surgery
Pain score 1-3 days after surgery 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
3-year disease free survival rate 36 months after surgery 3-year disease free survival rate
5-year overall survival rate 60 months after surgery 5-year overall survival rate
Trial Locations
- Locations (1)
Ruijin Hospital North
🇨🇳Shanghai, Shanghai, China