关键词: Conventional laparoscopy Gynecologic oncology Morbidity Prognostics factors Randomized phase III trial Robotic-assisted laparoscopy

Mesh : Adult Aged Female Humans Middle Aged Follow-Up Studies Genital Neoplasms, Female / surgery Gynecologic Surgical Procedures / methods adverse effects Laparoscopy / adverse effects methods Minimally Invasive Surgical Procedures / adverse effects methods Morbidity Postoperative Complications / etiology Prognosis Robotic Surgical Procedures / adverse effects methods

来  源:   DOI:10.1245/s10434-024-15265-1   PDF(Pubmed)

Abstract:
BACKGROUND: This study was a secondary analysis of the ROBOGYN-1004 trial conducted between 2010 and 2015. The study aimed to identify factors that affect postoperative morbidity after either robot-assisted laparoscopy (RL) or conventional laparoscopy (CL) in gynecologic oncology.
METHODS: The study used two-level logistic regression analyses to evaluate the prognostic and predictive value of patient, surgery, and center characteristics in predicting severe postoperative morbidity 6 months after surgery.
RESULTS: This analysis included 368 patients. Severe morbidity occurred in 49 (28 %) of 176 patients who underwent RL versus 41 (21 %) of 192 patients who underwent CL (p = 0.15). In the multivariate analysis, after adjustment for the treatment group (RL vs CL), the risk of severe morbidity increased significantly for patients who had poorer performance status, with an odds ratio (OR) of 1.62 for the 1-point difference in the WHO performance score (95 % CI 1.06-2.47; p = 0.027) and according to the type of surgery (p < 0.001). A focus on complex surgical acts showed significant more morbidity in the RL group than in the CL group at the less experienced centers (OR, 3.31; 95 % CI 1.0-11; p = 0.05) compared with no impact at the experienced centers (OR, 0.87; 95 % CI 0.38-1.99; p = 0.75).
CONCLUSIONS: The findings suggest that the center\'s experience may have an impact on the risk of morbidity for patients undergoing complex robot-assisted surgical procedures.
摘要:
背景:这项研究是对2010年至2015年进行的ROBOGYN-1004试验的二次分析。该研究旨在确定影响妇科肿瘤机器人辅助腹腔镜(RL)或传统腹腔镜(CL)术后发病率的因素。
方法:本研究使用两水平logistic回归分析来评估患者的预后和预测价值。手术,以及预测术后6个月严重并发症的中心特征。
结果:该分析包括368例患者。176例接受RL的患者中有49例(28%)发生严重发病率,而192例接受CL的患者中有41例(21%)发生严重发病率(p=0.15)。在多变量分析中,在调整治疗组(RLvsCL)后,严重发病率的风险显着增加的患者谁有较差的表现状态,根据手术类型(p<0.001),WHO表现评分1分差异的比值比(OR)为1.62(95%CI1.06-2.47;p=0.027)。对复杂手术行为的关注显示,在经验不足的中心,RL组的发病率明显高于CL组(OR,3.31;95%CI1.0-11;p=0.05)与有经验的中心没有影响(OR,0.87;95%CI0.38-1.99;p=0.75)。
结论:研究结果表明,中心的经验可能对接受复杂机器人辅助外科手术的患者的发病风险有影响。
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