J Gastric Cancer.  2024 Jul;24(3):257-266. 10.5230/jgc.2024.24.e22.

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)

• Lee HH
• Lee CM
• Lee MS
• Jeong IH
• Son MW
• Kim CH
• Yoo MW
• Oh SJ
• Son YG
• Choi SI
• Jung MR
• Seo SH
• Park SH
• Hwang SH
• Min JS
• Park S

• KMID: 2560572
• DOI: http://doi.org/10.5230/jgc.2024.24.e22

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.

Keyword

Gastrectomy; Laparoscopy; Morbidity; Mortality; Stomach neoplasms