Clinical trial NCT02347956: The Safety and Feasibility of Reduced Port Robotic Distal Gastrectomy Using Single-site for Surgical Treatment of Early Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Keywords: robot surgery
reduced port
single-site
safety
feasibility
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: morbidity
timeFrame: 30 days
Secondary outcomes:
measure: mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
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citation: Vizza E, Corrado G, Mancini E, Baiocco E, Patrizi L, Fabrizi L, Colantonio L, Cimino M, Sindico S, Forastiere E. Robotic single-site hysterectomy in low risk endometrial cancer: a pilot study. Ann Surg Oncol. 2013 Aug;20(8):2759-64. doi: 10.1245/s10434-013-2922-9. Epub 2013 Mar 7.
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