jRCTs042180129CompletedNot Applicable
Feasibility, safety, effectiveness, and economical efficiency of robotic gastrectomy for resectable gastric cancer: a multi-institutional historically controlled prospective cohort study
Not provided0 sites330 target enrollmentStarted: October 17, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 330
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomized Controlled Trial
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Operable patients under general anesthesia
- •Histologically diagnosed gastric adenocarcionoma
- •cStage I or II disease curably treated with total, distal, or proximal gastrectomy with D1+ or D2 lymph node dissection
- •Not indicated for endoscopic resection
- •Age over 18
- •Informed consent is obtained
Exclusion Criteria
- •Patients with mental disorders
- •Preoperative use of chemotherapy
Outcomes
Primary Outcomes
-
Postoperative complications greater than Grade III according to Clavien-Dindo classification
Secondary Outcomes
- Postoperative Complications grater than Grade II
- Health outcomes measured by EuroQol 5 Dimension (EQ-5D)
- Total Medical Cost
- Overall survival
- Disease free survival
- Robotic gastrectomy success rate
- Conversion to laparotomy
- Intraoperative adverse effects
- Surgical outcomes
- Postoperative courses
- Surgery-Related Mortality
Investigators
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