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).
Han Hong Lee, Chang Min Lee, Moon-Soo Lee, In Ho Jeong, Myoung Won Son, Chang Hyun Kim, Moon-Won Yoo, Sung Jin Oh, Young-Gil Son, Sung Il Choi, Mi Ran Jung, Sang Hyuk Seo, Shin-Hoo Park, Seong Ho Hwang, Jae-Seok Min, Sungsoo Park
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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.
期刊介绍:
The Journal of Gastric Cancer (J Gastric Cancer) is an international peer-reviewed journal. Each issue carries high quality clinical and translational researches on gastric neoplasms. Editorial Board of J Gastric Cancer publishes original articles on pathophysiology, molecular oncology, diagnosis, treatment, and prevention of gastric cancer as well as articles on dietary control and improving the quality of life for gastric cancer patients. J Gastric Cancer includes case reports, review articles, how I do it articles, editorials, and letters to the editor.