The Safety and Effect of Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer： Randomized Control Trial Study

Xu jianmin1 site in 1 country160 target enrollmentSeptember 1, 2015

ConditionsColorectal Liver Metastasis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Colorectal Liver Metastasis
Sponsor: Xu jianmin
Enrollment: 160
Locations: 1
Primary Endpoint: Surgical Complication
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of robot-assisted simultaneous resection in selected patients with sigmoid colon cancer or rectal cancer liver metastases, and compared with the traditional open procedure.

Detailed Description

The Da Vinci Surgical System may help to overcome some of the difficulties of laparoscopy for complicated abdominal surgery. The aim of this study was to present an innovative technique that is robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).

Registry

clinicaltrials.gov

Start Date

September 1, 2015

End Date

September 1, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xu jianmin

Responsible Party

Sponsor Investigator

Principal Investigator

Xu jianmin

Fudan University

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 and ≤ 75 years;
•Primary tumor has undergone histologically confirmed colon adenocarcinoma; Colon cancer was defined by the presence of the inferior pole of the tumor above the peritoneal reflection (at least 15 cm from the anal margin).
•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 2010 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system);Liver metastasis was diagnosis by multidisciplinary (MDT) team base on liver Magnetic Resonance Imaging (MRI) and Positron Emission Computed Tomography (PET-CT).
•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.
•The liver resectability was evaluated by liver surgery of MDT team, indication including: tumor number ≤ 3; the Maximum diameter of one tumor ≤ 10 cm.

Exclusion Criteria

•Body mass index (BMI) more than 30 kg/m
•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.
•Liver tumor located at I or invasive the middle hepatic vein.