NCT05051670

da Vinci SP Robotic Gastrectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	da vinc SP gastrectomy	radical subtotal gastrectomy performed by da vinci SP

Timeline

• Start date: 2021-12-16
• Primary completion: 2022-11-11
• Completion: 2022-12-11
• First posted: 2021-09-21
• Last updated: 2023-06-27

Locations

1 site across 1 country: South Korea