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).

IF 4.3 3区材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC

ACS Applied Electronic Materials Pub Date : 2024-07-01 DOI:10.5230/jgc.2024.24.e22

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.

Trial registration: ClinicalTrials.gov Identifier: NCT03393182.

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腹腔镜辅助远端胃切除术和全腹腔镜远端胃切除术治疗胃癌后的发病率和死亡率：中期报告：一项 III 期多中心、前瞻性、随机试验（KLASS-07 试验）。

目的：我们进行了一项随机前瞻性试验（KLASS-07 试验），比较腹腔镜辅助远端胃切除术（LADG）和全腹腔镜远端胃切除术（TLDG）治疗胃癌的效果。在这份中期报告中，我们描述了发病率和死亡率方面的短期结果：样本量为 442 人。在进行中期分析时，有 314 名患者被随机纳入。在排除未按计划接受手术的患者后，我们分别对 LADG 组和 TLDG 组的 151 名和 145 名患者进行了修改后的按方案分析：结果：LADG 组和 TLDG 组的基线特征（包括合并症状况）没有差异。LADG 组失血量稍高，但未达到统计学意义（76.76±72.63 对 62.91±65.68 mL；P=0.087）。两组所需的输血量、手术或重建时间均无差异。LADG 组的小切口明显长于 TLDG 组移除标本所需的延长脐切口（4.79±0.82 cm vs. 3.89±0.83 cm；P=0.087）：LADG 组和 TLDG 组的短期发病率和死亡率没有差异。KLASS-07试验目前正在进行中：试验注册：ClinicalTrials.gov Identifier：试验注册：ClinicalTrials.gov Identifier：NCT03393182。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

ACS Applied Electronic Materials Multiple-

CiteScore

7.20

自引率

4.30%

发文量

567