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Morbidity and Mortality After Laparoscopy-Assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy to Treat Gastric Cancer: An Interim Report: A Phase III Multicenter, Prospective, Randomized Trial (The KLASS-07 Trial)

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Author(s)
Han Hong LeeChang Min LeeMoon-Soo LeeIn Ho JeongMyoung Won SonChang Hyun KimMoon-Won YooSung Jin OhYoung-Gil SonSung Il ChoiMi Ran JungSang Hyuk SeoShin-Hoo ParkSeong Ho HwangJae-Seok MinSungsoo Park
Keimyung Author(s)
Son, Young Gil
Department
Dept. of Surgery (외과학)
Journal Title
J Gastric Cancer
Issued Date
2024
Volume
24
Issue
3
Keyword
GastrectomyLaparoscopyMorbidityMortalityStomach neoplasms
Abstract
Purpose:
We conducted a randomized prospective trial (KLASS-07 trial) to compare laparoscopy-assisted distal gastrectomy (LADG) and totally laparoscopic distal gastrectomy (TLDG) for gastric cancer. In this interim report, we describe short-term results in terms of morbidity and mortality.

Methods and Methods:
The sample size was 442 participants. At the time of the interim analysis, 314 patients were enrolled and randomized. After excluding patients who did not undergo planned surgeries, we performed a modified per-protocol analysis of 151 and 145 patients in the LADG and TLDG groups, respectively.

Results:
The baseline characteristics, including comorbidity status, did not differ between the LADG and TLDG groups. Blood loss was somewhat higher in the LADG group, but statistical significance was not attained (76.76±72.63 vs. 62.91±65.68 mL; P=0.087). Neither the required transfusion level nor the operation or reconstruction time differed between the 2 groups. The mini-laparotomy incision in the LADG group was significantly longer than the extended umbilical incision required for specimen removal in the TLDG group (4.79±0.82 vs. 3.89±0.83 cm; P<0.001). There were no between-group differences in the time to solid food intake, hospital stay, pain score, or complications within 30 days postoperatively. No mortality was observed in either group.

Conclusions:
Short-term morbidity and mortality rates did not differ between the LADG and TLDG groups. The KLASS-07 trial is currently underway.
Keimyung Author(s)(Kor)
손영길
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
2045-2322
Source
https://jgc-online.org/DOIx.php?id=10.5230/jgc.2024.24.e22
DOI
10.5230/jgc.2024.24.e22
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/45780
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Surgery (외과학)
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