Status:
WITHDRAWN
Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer
Lead Sponsor:
Ruijin Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
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 tota...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03413930
Start Date
June 1 2019
End Date
March 1 2026
Last Update
February 17 2020
Active Locations (1)
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1
Ruijin Hospital North
Shanghai, Shanghai Municipality, China, 201821