首页> 美国卫生研究院文献>International Surgery >Five Year Follow-Up of a Randomized Controlled Trial on Warming and Humidification of Insufflation Gas in Laparoscopic Colonic Surgery—Impact on Small Bowel Obstruction and Oncologic Outcomes
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Five Year Follow-Up of a Randomized Controlled Trial on Warming and Humidification of Insufflation Gas in Laparoscopic Colonic Surgery—Impact on Small Bowel Obstruction and Oncologic Outcomes

机译:腹腔镜结肠手术中放气加温加湿的随机对照试验五年随访—对小肠梗阻和肿瘤结果的影响

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摘要

Warming and humidification of insufflation gas has been shown to reduce adhesion formation and tumor implantation in the laboratory setting, but clinical evidence is lacking. We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced adhesion formation, and improve oncologic outcomes in laparoscopic colonic surgery. This was a 5-year follow-up of a multicenter, double-blinded, randomized, controlled trial investigating warming and humidification of insufflation gas. The study group received warmed (37°C), humidified (98%) insufflation carbon dioxide, and the control group received standard gas (19°C, 0%). All other aspects of patient care were standardized. Admissions for small bowel obstruction were recorded, as well as whether management was operative or nonoperative. Local and systemic cancer recurrence, 5-year overall survival, and cancer specific survival rates were also recorded. Eighty two patients were randomized, with 41 in each arm. Groups were well matched at baseline. There was no difference between the study and control groups in the rate of clinical small bowel obstruction (5.7% versus 0%, P 0.226); local recurrence (6.5% versus 6.1%, P 1.000); overall survival (85.7% versus 82.1%, P 0.759); or cancer-specific survival (90.3% versus 87.9%, P 1.000). Warming and humidification of insufflation CO2 in laparoscopic colonic surgery does not appear to confer a clinically significant long term benefit in terms of adhesion reduction or oncological outcomes, although a much larger randomized controlled trial (RCT) would be required to confirm this. ClinicalTrials.gov Trial identifier: ; US National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, USA.
机译:在实验室环境中,注入气体的加热和加湿已被证明可以减少粘连的形成和肿瘤的植入,但是缺乏临床证据。我们旨在检验以下假设:在腹腔镜结肠手术中,吹入二氧化碳的加湿会导致粘连形成减少,并改善肿瘤学结局。这是一项多中心,双盲,随机,对照试验的5年随访,该试验研究了注入气体的加热和加湿。研究组接受温暖的(37°C),加湿(98%)的吹入二氧化碳,对照组接受标准气体(19°C,0%)。病人护理的所有其他方面均已标准化。记录小肠梗阻的入院率,以及是否进行手术治疗。还记录了局部和全身性癌症复发,5年总体生存率以及癌症特异性生存率。随机分配82位患者,每组41位。各组在基线时匹配良好。研究组和对照组之间的临床小肠梗阻发生率没有差异(5.7%比0%,P = 0.226)。局部复发率(6.5%对6.1%,P 1.000);总体生存率(85.7%对82.1%,P 0.759);或癌症特异性生存率(90.3%对87.9%,P = 1.000)。尽管需要进行更大的随机对照试验(RCT)来证实,但在腹腔镜结肠手术中对注入二氧化碳进行加温和加湿似乎并不能在减少粘连或肿瘤结局方面带来临床上的长期意义。 ClinicalTrials.gov试用标识符:;美国国家医学图书馆,8600 Rockville Pike,贝塞斯达,马里兰州20894,美国。

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