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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02347956
Enrollment
19
Registered
2015-01-28
Start date
2015-01-31
Completion date
2015-11-30
Last updated
2015-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

robot surgery, reduced port, single-site, safety, feasibility

Brief summary

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.

Interventions

PROCEDUREReduced port robotic distal gastrectomy

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. A resectable, tissue confirmed adenocarcinoma of the stomach 2. Early gastric cancer curable by distal gastrectomy 3. AGE: 20-70 4. ECOG: 0-1 5. ASA score 1-3 6. A patient who signed the informed consent

Exclusion criteria

1. Advanced lesion with metastatic cancer 2. lesion which is curable by EMR or ESD 3. Previous major abdominal surgery 4. Complicated gastric cancer (obstruction or perforation) 5. History with other primary tumor within 5 year 6. Active other primary tumor 7. Vulnerable subjects (pregnant women, illiterate)

Design outcomes

Primary

MeasureTime frame
morbidity30 days

Secondary

MeasureTime frame
mortality30 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026