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Morbidity and Mortality of Laparoscopic Gastrectomy Versus Open Gastrectomy for Gastric Cancer An Interim Report-A Phase III Multicenter, Prospective, Randomized Trial (KLASS Trial)

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Author(s)
류승완
Alternative Author(s)
Ryu, Seung Wan
Publication Year
2010
Abstract
Objective: The aim of this study was to evaluate the safety of this trial with
respect to morbidity and mortality.
Summary Background Data: Laparoscopic-assisted distal gastrectomy
(LADG) is rapidly gaining popularity. However, there is limited evidence
regarding its oncologic safety. We therefore conducted a phase III multicenter,
prospective, randomized study comparing LADG with open gastrectomy
(ODG).
Methods: Patient eligibility criteria were pathologically-proven adenocarcinoma,
20 to 80 years of age, preoperative stage I, no history of other cancer,
chemotherapy, or radiotherapy. The primary end point was to determine
whether there is a difference in overall survival between 2 groups. The
morbidity and mortality were compared to evaluate the safety of this trial.
The time was decided on the hypothesis that the morbidity of this trial was
not significantly different from that of previous reports on open gastric
cancer surgeries (17%–20%). This study is registered at ClinicalTrials.gov
and carries the following ID number: NCT00452751.
Results: A total of 342 patients were randomized (LADG, 179 patients;
ODG, 161 patients) between January 1, 2006 and July 19, 2007. There were
no significant differences between the 2 groups in age, gender, and comorbidities.
The postoperative complication rates of the LADG and ODG groups
were 10.5% (17/179) and 14.7% (24/163), respectively (P 0.137). Reoperations
were required in 3 cases each group. The postoperative mortality
was 1.1% (2/179) and 0% (0/163) in the LADG and ODG groups (P
0.497), respectively.
Conclusion: There was no significance difference in the morbidity and
mortality between the 2 groups. Therefore, we conclude that this trial is safe
and is thus ongoing.
(Ann Surg 2010;251: 417–420)
Department
Dept. of Surgery (외과학)
Publisher
School of Medicine
Citation
Annals of Surgery, Vol.251(3) : 417-420, 2010
Type
Article
ISSN
0003-4932
DOI
10.1097/SLA.0b013e3181cc8f6b
URI
http://kumel.medlib.dsmc.or.kr/handle/2015.oak/35040
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