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Spots Global Cancer Trial Database for da Vinci SP Robotic Gastrectomy

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Trial Identification

Brief Title: da Vinci SP Robotic Gastrectomy

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

Study ID: NCT05051670

Conditions

Gastric Cancer

Study Description

Brief 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.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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