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- Title
Late phase II study of robot-assisted gastrectomy with nodal dissection for clinical stage I gastric cancer.
- Authors
Tokunaga, Masanori; Makuuchi, Rie; Miki, Yuiciro; Tanizawa, Yutaka; Bando, Etsuro; Kawamura, Taiichi; Terashima, Masanori
- Abstract
<bold>Background: </bold>The feasibility of robot-assisted gastrectomy (RG) in terms of safety is unclear due to a lack of prospective studies. We showed feasible surgical outcomes in our previous study. In this phase II study, we assessed feasibility of the procedure by recruiting a larger number of patients.<bold>Method: </bold>This single-center, prospective phase II study included patients with clinical stage I gastric cancer undergoing RG. The primary end point was the incidence of postoperative intra-abdominal infectious complications, including anastomotic leakage, pancreas-related infection, and intra-abdominal abscess. The secondary end points were overall survival, relapse-free survival, RG completion rate, and incidence of all surgical morbidities.<bold>Results: </bold>A total of 120 patients were recruited between December 2012 and April 2015. The incidence of intra-abdominal infectious complications was 3.3 % (95 % CI 0.9-8.3 %), and all complications were successfully treated conservatively without re-operation. The incidence of overall adverse events was 14.2 % (95 % CI 8.5-21.7 %). Three patients required conversion to open gastrectomy according to the protocol due to advancement of disease.<bold>Conclusion: </bold>Our data show that RG is safe in terms of the incidence and severity of postoperative complications.
- Subjects
STOMACH cancer treatment; GASTRECTOMY; SURGICAL robots; INTRA-abdominal infections; DISEASE complications; THERAPEUTICS; ADENOCARCINOMA; CLINICAL trials; COMPARATIVE studies; SURGICAL excision; LONGITUDINAL method; LYMPH node surgery; RESEARCH methodology; MEDICAL cooperation; RESEARCH; STOMACH tumors; SURGICAL complications; OPERATIVE surgery; EVALUATION research
- Publication
Surgical Endoscopy & Other Interventional Techniques, 2016, Vol 30, Issue 8, p3362
- ISSN
1866-6817
- Publication type
journal article
- DOI
10.1007/s00464-015-4613-z