Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube in Robotic Low Anterior Resection
NCT ID: NCT03609710
Last Updated: 2018-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2018-01-01
2019-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PSTLAR
Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer
Transanal tube placement
Transanual tube placement after anastomosis in low anterior resection for rectal cancer.
Left colic artery preservation
Left colic artery preservation during operation for lower rectal cancer
Anastomotic reinforcing sutures
Anastomotic reinforcing sutures during operation for lower rectal cancer
Robotic surgery
Robotic low anterior resection for rectal cancer
NORLAR
Traditional robotic low anterior resection for rectal cancer without left colic artery preservation, anastomotic reinforcing sutures or postoperative transanal tube placement
Robotic surgery
Robotic low anterior resection for rectal cancer
Interventions
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Transanal tube placement
Transanual tube placement after anastomosis in low anterior resection for rectal cancer.
Left colic artery preservation
Left colic artery preservation during operation for lower rectal cancer
Anastomotic reinforcing sutures
Anastomotic reinforcing sutures during operation for lower rectal cancer
Robotic surgery
Robotic low anterior resection for rectal cancer
Eligibility Criteria
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Inclusion Criteria
* Primary tumor has undergone histologically comfirmed rectal adenocarcinoma
* Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2016 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system)
* Performance status (ECOG) 0\~1
* Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
* Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either primary tumor, regional nodes, metastasis (AST) or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
* Written informed consent for participation in the trial.
Exclusion Criteria
* Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine \>2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history
* History of accepting abdominal surgery
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xu jianmin
Prof.
Locations
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Jianmin Xu
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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PSTLAR
Identifier Type: -
Identifier Source: org_study_id
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