Clinical trial NCT03609710: Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube in Robotic Low Anterior Resection
Official title: The Effect of Combined Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube Placement in Robotic Low Anterior Resection for Rectal Cancer to Prevent Anastomic Leak：A Prospective, Single-center, Randomized Control Trial Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: Low rectal cancer
Robotic surgery
Anastomotic leak
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the results of combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic Low Anterior Resection for Rectal Cancer.

Detailed description: Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of low rectal cancer; Low rectal cancer was defined by the presence of the inferior pole of the tumor below the peritoneal reflection (in 11 cm from the anal margin)
* 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:

* Body mass index (BMI) more than 30 kg/m2
* 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

Primary outcomes:
measure: Anastomotic leak rate
timeFrame: 30 days post operatively
Secondary outcomes:
measure: Reoperation rate after anastomotic leak
timeFrame: 30 days post operatively
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Jianmin Xu
state: Shanghai
Study officials:
References: