Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube in Robotic Low Anterior Resection

Study Overview
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Brief Summary
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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
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Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer

Official Title
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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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Device: Transanal tube placement
* Procedure: Left colic artery preservation
* Procedure: Anastomotic reinforcing sutures
* Device: Robotic surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSTLAR<br>Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer | Device: Transanal tube placement<br>* Transanual tube placement after anastomosis in low anterior resection for rectal cancer.<br>Procedure: Left colic artery preservation<br>* Left colic artery preservation during operation for lower rectal cancer<br>Procedure: Anastomotic reinforcing sutures<br>* Anastomotic reinforcing sutures during operation for lower rectal cancer<br>Device: Robotic surgery<br>* Robotic low anterior resection for rectal cancer<br>|
| Active Comparator: NORLAR<br>Traditional robotic low anterior resection for rectal cancer without left colic artery preservation, anastomotic reinforcing sutures or postoperative transanal tube placement | Device: Robotic surgery<br>* Robotic low anterior resection for rectal cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leak rate | Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to re-operation. | 30 days post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation rate after anastomotic leak | Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to excrement peritonitis, and re-operation as colostomy | 30 days post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low rectal cancer, Robotic surgery, Anastomotic leak