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

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Device: Transanal tube placement; Procedure: Left colic artery preservation; Procedure: Anastomotic reinforcing sutures; Device: Robotic surgery

• Registration Number: NCT03609710
• Lead Sponsor: Fudan University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-01
• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-01
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03
• Primary Completion: 2019-02-28
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PSTLAR	Transanal tube placement	Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer
PSTLAR	Anastomotic reinforcing sutures	Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer
PSTLAR	Robotic surgery	Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer
NORLAR	Robotic surgery	Traditional robotic low anterior resection for rectal cancer without left colic artery preservation, anastomotic reinforcing sutures or postoperative transanal tube placement
PSTLAR	Left colic artery preservation	Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer

Primary Outcome Measures

Name	Time	Method
Anastomotic leak rate	30 days post operatively	Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to re-operation.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jianmin Xu; 🇨🇳 Shanghai, Shanghai, China