Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01)
- Author(s)
- Wook Kim; Hyung-Ho Kim; Sang-Uk Han; Min-Chan Kim; Woo Jin Hyung; Seung Wan Ryu; Gyu Seok Cho; Chan Young Kim; Han-Kwang Yang; Do Joong Park; Kyo Young Song; Sang Il Lee; Seung Yub Ryu; Joo-Ho Lee; Hyuk-Joon Lee
- Keimyung Author(s)
- Ryu, Seung Wan
- Department
- Dept. of Surgery (외과학)
- Journal Title
- Annals of Surgery
- Issued Date
- 2016
- Volume
- 263
- Issue
- 1
- Keyword
- Complication; Laparoscopy; Morbidity; Mortality; Stomach neoplasm
- Abstract
- Objective: To determine the safety of laparoscopy-assisted distal gastrectomy
(LADG) compared with open distal gastrectomy (ODG) in patients with
clinical stage I gastric cancer in Korea.
Background: There is still a lack of large-scale, multicenter randomized
trials regarding the safety of LADG.
Methods: A large-scale, phase 3, multicenter, prospective randomized controlled
trial was conducted. The primary end point was 5-year overall survival.
Morbidity within 30 postoperative days and surgical mortality were compared
to evaluate the safety of LADG as a secondary end point
Results: A total of 1416 patients were randomly assigned to the LADG group
(n¼705) or the ODG group (n¼711) between February 1, 2006, and August
31, 2010, and 1384 patients were analyzed for modified intention-to-treat
analysis (ITT) and 1256 were eligible for per protocol (PP) analysis (644 and
612, respectively). In the PP analysis, 6 patients (0.9%) needed open conversion
in the LADG group. The overall complication rate was significantly
lower in the LADG group (LADG vs ODG; 13.0% vs 19.9%, P¼0.001). In
detail, the wound complication rate of the LADG group was significantly
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