Status:
UNKNOWN
Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer
Lead Sponsor:
Shanghai Minimally Invasive Surgery Center
Conditions:
Rectal Cancer
Surgery
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Total mesorectal excision (TME) has been prevailingly accepted as a crucial surgical intervention within the latest oncological therapeutic regime for mid-low rectal cancer. However, surgical dissecti...
Detailed Description
Background: Transanal total mesorectal excision (TaTME) is increasingly accepted as one of the alternative patterns for the resectable rectal cancer worldwide since its first appearance. For mid-low r...
Eligibility Criteria
Inclusion
- Rectal adenocarcinoma validated by pathologists, pathological estimated stage II-III;
- Mid and low rectal tumor sites, parameter less than 5cm, below the level of peritoneal reflection and verified by MRI, distance to anus less than 7 cm;
- Curative rectal cancer surgery;
- No evidence of distance metastasis lesions;
- T1-3, N0-2, with or without neoadjuvant therapeutic history;
- Applied to laparoscopic surgery;
- Absent of previous malignancy-treated history
- No gender restriction, age between 18 and 75, Body Mass Index less than 32;
- Approved by multiple disciplinary teamwork therapeutic group
- Consent by the patient and the family.
Exclusion
- Mile's surgery is additionally required;
- Tumor invasion is validated on adjacent organs, such as prostate;
- Recurrent rectal cancer, require secondary surgical interventions;
- Previous history of malignant diseases or inflammatory bowel diseases within recent five years;
- Emergent surgery accompanied by bowel obstruction or intestinal perforation;
- Previous history of colorectal surgery, unnatural anatomical structure;
- Contraindication to general anesthesia (class IV or V in American Society of Anesthesiologists (ASA), or Eastern Cooperative Oncology Group (ECOG) score \>=2)
- Pregnant or breast-feeding patients;
- Mental disorder validated by psychiatrists.
- Uncontrolled infectious diseases;
- Participants within other related clinical trials that may influence the conclusion of this trial;
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT03359616
Start Date
January 1 2018
End Date
January 1 2022
Last Update
December 2 2017
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