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Abstract：
OBJECTIVE: Postoperative ileus (POI) is a major problem after colorectal surgery. Acetylcholinesterase inhibitors such as pyridostigmine increase gastrointestinal (GI) motility through a cholinergic anti-inflammatory pathway. The purpose of this phase II pilot study is to determine the safety of oral pyridostigmine after elective colorectal surgery.
METHODS: This is a Stage 2b safety study (IDEAL framework). All adult patients undergoing elective colorectal resection or formation or reversal of stoma at the Royal Adelaide Hospital between September 2020 and January 2021 were eligible. The primary outcomes were 30-day postoperative complications, reported adverse events and GI-2 - a validated composite outcome measure of recovery of GI function after surgery, defined as the interval from surgery until first passage of stool and tolerance of a solid intake for 24 h (in whole days) in the absence of vomiting.
RESULTS: Fifteen patients were included in the study. The median age was 58 (range 50-82) years and seven (47%) were men. Most participants had an American Society of Anesthesiologists grade ≥2 (53%) and the median body mass index was 27 (24-35) kg/m2 . There were 13 postoperative complications [seven were Clavien-Dindo (CD) 1, five CD 2 and one CD 3]. None appeared directly related to pyridostigmine administration, and none of the patients had any overt symptoms of excessive parasympathetic activity. Median GI-2 was 2 (1-4) days.
CONCLUSIONS: Oral pyridostigmine appears to be safe to use after elective colorectal surgery in a select group of patients. However, considering this is a pilot study with a small sample size, larger controlled studies are needed to confirm this finding and establish efficacy for prevention of POI.
METHODS: This is a Stage 2b safety study (IDEAL framework). All adult patients undergoing elective colorectal resection or formation or reversal of stoma at the Royal Adelaide Hospital between September 2020 and January 2021 were eligible. The primary outcomes were 30-day postoperative complications, reported adverse events and GI-2 - a validated composite outcome measure of recovery of GI function after surgery, defined as the interval from surgery until first passage of stool and tolerance of a solid intake for 24 h (in whole days) in the absence of vomiting.
RESULTS: Fifteen patients were included in the study. The median age was 58 (range 50-82) years and seven (47%) were men. Most participants had an American Society of Anesthesiologists grade ≥2 (53%) and the median body mass index was 27 (24-35) kg/m2 . There were 13 postoperative complications [seven were Clavien-Dindo (CD) 1, five CD 2 and one CD 3]. None appeared directly related to pyridostigmine administration, and none of the patients had any overt symptoms of excessive parasympathetic activity. Median GI-2 was 2 (1-4) days.
CONCLUSIONS: Oral pyridostigmine appears to be safe to use after elective colorectal surgery in a select group of patients. However, considering this is a pilot study with a small sample size, larger controlled studies are needed to confirm this finding and establish efficacy for prevention of POI.
摘要：
目的：术后肠梗阻（POI）是结直肠手术后的主要问题。乙酰胆碱酯酶抑制剂如吡啶斯的明通过胆碱能抗炎途径增加胃肠(GI)运动。这项II期初步研究的目的是确定选择性结直肠手术后口服吡啶斯的明的安全性。
方法：这是一项2b期安全性研究（IDEAL框架）。所有在2020年9月至2021年1月期间在皇家阿德莱德医院接受选择性结直肠切除术或造口形成或逆转的成年患者均符合资格。主要结果是术后30天并发症，报告的不良事件和GI-2-手术后胃肠道功能恢复的有效复合结局指标，定义为在没有呕吐的情况下，从手术到首次大便和24小时（整日）固体摄入的耐受性的间隔。
结果：本研究纳入了15例患者。中位年龄为58岁（50-82岁），男性为7岁（47%）。大多数参与者的美国麻醉医师协会等级≥2（53％），中位体重指数为27（24-35）kg/m2。术后并发症13例[Clavien-Dindo（CD）17例，CD25例和CD31例]。似乎没有与吡啶斯的明给药直接相关，并且没有患者有任何明显的副交感神经活动过度的症状。GI-2的中位数为2(1-4)天。
结论：在选定的一组患者中，择期结直肠手术后使用口服吡啶斯的明似乎是安全的。然而,考虑到这是一项样本量小的试点研究，需要更大规模的对照研究来证实这一发现,并确定预防POI的有效性.
方法：这是一项2b期安全性研究（IDEAL框架）。所有在2020年9月至2021年1月期间在皇家阿德莱德医院接受选择性结直肠切除术或造口形成或逆转的成年患者均符合资格。主要结果是术后30天并发症，报告的不良事件和GI-2-手术后胃肠道功能恢复的有效复合结局指标，定义为在没有呕吐的情况下，从手术到首次大便和24小时（整日）固体摄入的耐受性的间隔。
结果：本研究纳入了15例患者。中位年龄为58岁（50-82岁），男性为7岁（47%）。大多数参与者的美国麻醉医师协会等级≥2（53％），中位体重指数为27（24-35）kg/m2。术后并发症13例[Clavien-Dindo（CD）17例，CD25例和CD31例]。似乎没有与吡啶斯的明给药直接相关，并且没有患者有任何明显的副交感神经活动过度的症状。GI-2的中位数为2(1-4)天。
结论：在选定的一组患者中，择期结直肠手术后使用口服吡啶斯的明似乎是安全的。然而,考虑到这是一项样本量小的试点研究，需要更大规模的对照研究来证实这一发现,并确定预防POI的有效性.
