Status:
UNKNOWN
Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer.
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This study is designed as a prospective, multi-center, randomized, open-labelled, parallel group, non-inferiority trial. The aim of this study is to evaluate the TaTME technique compared with conventi...
Detailed Description
This study is designed as a prospective, multi-center, randomized, open-labelled, parallel group, non-inferiority trial. The patients will be randomized and assigned to transanal mesorectal excision (...
Eligibility Criteria
Inclusion
- histologically proven solitary mid and low rectal cancer
- proven by rigid rectoscopy, pelvic MRI and digital rectal examination (DRE)
- amenable to curative sphincter-preserving surgery
- no evidence of distant metastases (T3-4a,N0 or T1-4a,N1-2)
- if evaluated after neoadiuvant therapy, no evidence of threaten of the mesorectal fascia (MRF) after therapy
Exclusion
- no indication to perform sphincter preservation surgery (Tumors invading into the internal anal sphincter muscle based on pelvic MRI)
- T4b tumor invading adjacent organs
- recurrent cancer
- concurrent or previous diagnosis of invasive cancer within 5 years
- prior history of colorectal resection
- tumors with in growth more than 1/3 of anal sphincter complex or levator ani.
- presence of fecal incontinence at baseline according to Wexner's classification
- emergent surgery with intestinal obstruction or perforation
- absolute contraindications to general anaesthesia or prolonged pneumoperitoneum, such as severe cardiovascular or respiratory disease (ASA class \> III)
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2023
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT03413904
Start Date
March 27 2018
End Date
February 28 2023
Last Update
August 9 2018
Active Locations (1)
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1
IRCCS San Raffaele
Milan, Italy, 20060