The Safety and Feasibility of Reduced Port Robotic Distal Gastrectomy Using Single-site for Surgical Treatment of Early Gastric Cancer

Study Overview
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Brief Summary
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Gastric cancer is one of the most common malignancy worldwide. Surgical resection of the tumor is the only curative treatment for gastric cancer. However, surgical procedure accompanies postoperative pain and prolonged hospitalization. To lessen the surgical trauma and stress, minimally invasive surgery were introduced. Laparoscopic gastrectomy was accepted as safe and effective alternative to open gastrectomy. Furthermore, reduced port and single port laparoscopic gastrectomy are considered to minimize the surgical trauma during gastrectomy. However, limitations of laparoscopic approach using reduced port includes unergonomic posture of surgeon, physiologic tremor and collision of instruments. To overcome these limitations, robot surgery using novel single-site technology enabled surgeons to perform the surgical procedure reducing the number of trocar from three to one for insertion of scope and two robotic arms. Previously, successful application of single-site technology for cholecystectomy and hysterectomy were reported. The aim of this study is to validate the safety and feasibility of reduced port robotic distal gastrectomy using single-site technology for the surgical treatment of gastric cancer.

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Reduced port robotic distal gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A resectable, tissue confirmed adenocarcinoma of the stomach Early gastric cancer curable by distal gastrectomy AGE: 20-70 ECOG: 0-1 ASA score 1-3 A patient who signed the informed consent Exclusion Criteria: Advanced lesion with metastatic cancer lesion which is curable by EMR or ESD Previous major abdominal surgery Complicated gastric cancer (obstruction or perforation) History with other primary tumor within 5 year Active other primary tumor Vulnerable subjects (pregnant women, illiterate)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduced port group<br> | Procedure: Reduced port robotic distal gastrectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robot surgery, reduced port, single-site, safety, feasibility