Status:
COMPLETED
The Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Rectal Cancer
Surgery
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
During the past three years, a revolutionized radical surgical approach for rectal cancer ("down to up TME " approach or "transanal TME (TaTME)"approach, which is opposite to the conventional approach...
Detailed Description
Transanal total mesorectal excision (TaTME) is a novel development in the field of colorectal surgery which combines the mini-invasive concept of natural orifice transluminal endoscopic surgery(NOTES)...
Eligibility Criteria
Inclusion
- Biopsy-proven adenocarcinoma of the rectum
- No previous abdominal surgery, no distant metastasis or synchronous colon cancer
- BMI≤ 35kg/m2
- Clinical staging (T1 or T2 or T3) with N1-2M0
- Patients of rectal adenocarcinoma with T3N0 or N (+) received preoperative concurrent chemoradiotherapy (CCRT) as neoadjuvant therapy
- Rectal cancer located 4-12 cm from the anal verge
- The diameter of primary tumor should \<6cm
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- American Society of Anesthesiology (ASA) classⅠ to Ⅲ lesions
- After the evaluation of Multi-disciplinary team (MDT)
- Written informed consent
Exclusion
- T4 tumor that invade the external sphincter or levator ani muscle or neighbor organs
- Recurrent rectal cancer
- Distant metastasis
- Obstructing rectal cancer
- Synchronous colon cancer
- Pregnant or breast-feeding women
- Fecal incontinence
- History of prior colorectal cancer
- History of inflammatory bowel disease
- Other malignancies diagnosed within the previous year
- Mental illness
- Any evidence of active infection
- History of bleeding diathesis or coagulopathy
- Impaired renal or hepatic function that could not tolerate surgery
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02236884
Start Date
September 1 2014
End Date
June 1 2016
Last Update
December 19 2016
Active Locations (1)
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1
Gastrointestinal Hospital, Sun Yatsen University
Guangzhou, Guangdong, China, 510655