PDF(Pubmed)
Abstract：
OBJECTIVE: 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.
UNASSIGNED: 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.
BACKGROUND: ClinicalTrials.gov Identifier: NCT03393182.
UNASSIGNED: 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.
BACKGROUND: ClinicalTrials.gov Identifier: NCT03393182.
摘要：
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）和完全腹腔镜远端胃切除术（TLDG）治疗胃癌的疗效。在这份中期报告中，我们从发病率和死亡率方面描述了短期结果.
■样本量为442名参与者。在中期分析时，314名患者被纳入并随机分组。在排除没有进行计划手术的患者后，我们对LADG和TLDG组的151和145名患者进行了改良的符合方案分析，分别。
结果：基线特征，包括共病状态，LADG和TLDG组之间没有差异。LADG组的失血量稍高，但没有达到统计学意义(76.76±72.63vs.62.91±65.68mL；P=0.087）。两组之间所需的输血水平，手术或重建时间均无差异。LADG组的小切口开腹切口明显长于TLDG组标本切除所需的延长脐带切口（4.79±0.82vs.3.89±0.83cm；P<0.001）。在固体食物摄入的时间上没有组间差异，住院,疼痛评分,或术后30天内出现并发症。两组均无死亡。
结论：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。
背景：ClinicalTrials.gov标识符：NCT03393182。
■样本量为442名参与者。在中期分析时，314名患者被纳入并随机分组。在排除没有进行计划手术的患者后，我们对LADG和TLDG组的151和145名患者进行了改良的符合方案分析，分别。
结果：基线特征，包括共病状态，LADG和TLDG组之间没有差异。LADG组的失血量稍高，但没有达到统计学意义(76.76±72.63vs.62.91±65.68mL；P=0.087）。两组之间所需的输血水平，手术或重建时间均无差异。LADG组的小切口开腹切口明显长于TLDG组标本切除所需的延长脐带切口（4.79±0.82vs.3.89±0.83cm；P<0.001）。在固体食物摄入的时间上没有组间差异，住院,疼痛评分,或术后30天内出现并发症。两组均无死亡。
结论：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。
背景：ClinicalTrials.gov标识符：NCT03393182。
