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OpenTrials
Completed

NCT Number: NCT05051670

da Vinci SP Robotic Gastrectomy

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

da vinc SP gastrectomy

Procedure

radical subtotal gastrectomy performed by da vinci SP

Primary outcomes

  1. major complication

    Time frame: 30 days after gastrectomy

    Clavien-Dindo classification grade 3 or more

Secondary outcomes

  1. Operation time

    Time frame: 30 days after gastrectomy

    duation of operation in minutes

  2. bleeding

    Time frame: 30 days after gastrectomy

    amount of bleeding shed during the operation in ml

  3. bowel recovery

    Time frame: 30 days after gastrectomy

    gas passing day after the surgery

  4. Hospital stay

    Time frame: 30 days after gastrectomy

    days between the opeation day to discharge day

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2021
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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