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腹腔镜结肠切除术后肠道转运的咖啡因:随机临床试验(CaCo 试验)。

Caffeine for intestinal transit after laparoscopic colectomy: randomized clinical trial (CaCo trial).

机构信息

Department of General, Visceral, Endocrine and Transplant Surgery, Kantonsspital St Gallen, St Gallen, Switzerland.

Department of Surgery and Transplantation, University Hospital Zurich, Zurich, Switzerland.

出版信息

Br J Surg. 2022 Nov 22;109(12):1216-1223. doi: 10.1093/bjs/znac265.

Abstract

BACKGROUND

Coffee has been suggested to help postoperative gastrointestinal motility but the mechanism is not known. This trial assessed whether caffeine shortened time to bowel activity after laparoscopic colectomy.

METHODS

This was a single-centre, randomized, double-blinded, placebo-controlled superiority trial (October 2015 to August 2020). Patients aged at least 18 years undergoing elective laparoscopic colectomy were assigned randomly to receive 100 mg or 200 mg caffeine, or a placebo (250 mg corn starch) three times a day orally. The primary endpoint was the time to first bowel movement. Secondary endpoints included colonic transit time, time to tolerance of solid food, duration of hospital stay, and perioperative morbidity.

RESULTS

Sixty patients were assigned randomly to either the 200-mg caffeine group (20 patients), the 100-mg caffeine group (20) or the placebo group (20). In the intention-to-treat analysis, the mean(s.d.) time to first bowel movement was 67.9(19.2) h in the 200-mg caffeine group, 68.2(32.2) h in the 100-mg caffeine group, and 67.3(22.7) h in the placebo group (P = 0.887). The per-protocol analysis and measurement of colonic transit time confirmed no measurable difference with caffeine.

CONCLUSION

Caffeine was not associated with reduced time to first bowel movement.

REGISTRATION NUMBER

NCT02510911 (http://www.clinicaltrials.gov).

摘要

背景

咖啡被认为有助于术后胃肠道蠕动,但具体机制尚不清楚。本试验评估了咖啡因是否能缩短腹腔镜结肠切除术后肠道活动的时间。

方法

这是一项单中心、随机、双盲、安慰剂对照的优效性试验(2015 年 10 月至 2020 年 8 月)。接受择期腹腔镜结肠切除术的年龄至少 18 岁的患者被随机分配接受每天口服 100mg 或 200mg 咖啡因或安慰剂(250mg 玉米淀粉)三次。主要终点是首次排便时间。次要终点包括结肠通过时间、耐受固体食物的时间、住院时间和围手术期发病率。

结果

60 例患者被随机分为 200mg 咖啡因组(20 例)、100mg 咖啡因组(20 例)或安慰剂组(20 例)。在意向治疗分析中,200mg 咖啡因组首次排便的平均(标准差)时间为 67.9(19.2)h,100mg 咖啡因组为 68.2(32.2)h,安慰剂组为 67.3(22.7)h(P = 0.887)。基于方案的分析和结肠通过时间的测量均证实咖啡因无明显差异。

结论

咖啡因与首次排便时间的缩短无关。

登记号

NCT02510911(http://www.clinicaltrials.gov)。

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