da Vinci SP Robotic Gastrectomy

Study Overview
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Brief Summary
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Laparoscopic surgery revolutionized the surgical treatment of gastric cancer saving large incsion and associated pain. Robotic surgical system was introduced to enhance the minimally invasive surgery using articulating robotic arm. The da vinci SP system, which enables single-port surgery, can allow surgeon to provide radical gastrectomy with minimal scar and associated pain.

Detailed Description
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This study is a phase 1/2, single-arm surgical clinical trial. The primary endpoint is the safety of da vinci robotic gastrectomy. The secondary endpoint is operative time, bleeding, bowel recovery, and hospital stay. In the clinic, informed consent is received from patient who is scheduled to undergo radical gastrectomy. After the general anesthesia, low midline transverse incision is made at suprapubic area. After inserting SP port into the peritoneal cavity, additional port is inserted via right flank that would be used for assistant's energy device and suction devices. Radical subtotal gastrectomy is perfromed using cardiere-forceps, monopolar scissors, and maryland forceps. Reconstruction after gastrectomy is decided according to surgeon's preference. three days after gastrectomy, if the diet build up is complete and the patients has no evidence of complication, the patient is discharged from the hospital. Four weeks after gastrectomy, the patient will be followed up at the clinic. Major complication event within 30days after gastrectomy will be analyzed as primary endpoint as well as other secondary endpoints.

Official Title
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The Safety and Feasibility of Reduced Port Robotic Distal Gastrectomy Using da Vinci SP for Early Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: da vinc SP gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy confirmed adenocarcinoma of stomach scheduled to undergo radical gastrectomy Between 20-80 ASA score (American society of anesthesiology) class: I - III Signed to informed consent after through explanation about the study Exclusion Criteria: distant metastasis EMR/ESD canddiate complicated gastric cancer (obstruction or perforation) Active other primary tumor Vulerable subject (illiterate, pregnant)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: SP group<br>patients group underwent gastrectomy using da vinci SP | Procedure: da vinc SP gastrectomy<br>* radical subtotal gastrectomy performed by da vinci SP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major complication | Clavien-Dindo classification grade 3 or more | 30 days after gastrectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | duation of operation in minutes | 30 days after gastrectomy | 
| bleeding | amount of bleeding shed during the operation in ml | 30 days after gastrectomy | 
| bowel recovery | gas passing day after the surgery | 30 days after gastrectomy | 
| Hospital stay | days between the opeation day to discharge day | 30 days after gastrectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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da vinci SP, robotic surgery, gastrectomy, gastric cancer