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评估术前肠道刺激在回肠袢式造口关闭术中减少术后肠梗阻的应用效果的研究方案:一项多中心随机对照试验。

Study protocol evaluating the use of bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter randomized controlled trial.

机构信息

Division of Colon and Rectal Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Québec, Canada.

Section of Colorectal Surgery, St. Paul's Hospital, Vancouver, British Columbia, Canada.

出版信息

Colorectal Dis. 2017 Nov;19(11):1024-1029. doi: 10.1111/codi.13720.

DOI:10.1111/codi.13720
PMID:28498636
Abstract

AIM

Postoperative ileus is the most commonly observed morbidity following ileostomy closure. Studies have demonstrated that the defunctionalized bowel of a loop ileostomy undergoes a series of functional and structural changes, such as atrophy of the intestinal villi and muscular layers, which may contribute to ileus. A single-centre study in Spain demonstrated that preoperative bowel stimulation via the distal limb of the loop ileostomy decreased postoperative ileus, length of stay and time to gastrointestinal function.

METHOD

A multicentre randomized controlled trial involving patients from Canadian institutions was designed to evaluate the effect of preoperative bowel stimulation before ileostomy closure on postoperative ileus. Stimulation will include canalizing the distal limb of the ileostomy loop with an 18Fr Foley catheter and infusing it with a solution of 500 ml of normal saline mixed with 30 g of a thickening agent (Nestle Thicken-Up ). This will be performed 10 times over the 3 weeks before ileostomy closure in an outpatient clinic setting by a trained Enterostomal Therapy nurse. Surgeons and the treating surgical team will be blinded to their patient's group allocation. Data regarding patient demographics, and operative and postoperative variables, will be collected prospectively. Primary outcome will be postoperative ileus, defined as an intolerance to oral food in the absence of clinical or radiological signs of obstruction, that either requires nasogastric tube insertion or is associated with two of the following on or after post-operative day 3: nausea/vomiting; abdominal distension; and the absence of flatus. Secondary outcomes will include length of stay, time to tolerating a regular diet, time to first passage of flatus or stool and overall morbidity. A cost analysis will be performed to compare the costs of conventional care with conventional care plus preoperative stimulation.

DISCUSSION

This manuscript discusses the potential benefits of preoperative bowel stimulation in improving postoperative outcomes and outlines our protocol for the first multicenter study to evaluate preoperative bowel stimulation before ileostomy closure. The results of this study could have considerable implications for the care of patients undergoing ileostomy closure.

摘要

目的

肠粘连是回肠造口关闭后最常见的并发症。研究表明,回肠袢式造口的无功能肠段经历了一系列的功能和结构变化,如肠绒毛和肌层萎缩,这可能导致肠粘连。西班牙的一项单中心研究表明,术前通过回肠造口的远段进行肠道刺激可减少术后肠粘连、住院时间和胃肠功能恢复时间。

方法

设计了一项涉及加拿大机构患者的多中心随机对照试验,以评估术前在回肠造口关闭前对肠刺激对术后肠粘连的影响。刺激将包括用 18Fr Foley 导管对回肠造口的远段进行管腔化,并向其中注入 500ml 生理盐水和 30g 增稠剂(雀巢 Thick-Up)的混合溶液。在门诊环境中,由经过培训的造口治疗护士在回肠造口关闭前的 3 周内进行 10 次操作。外科医生和治疗外科团队将对患者的分组分配保持盲态。前瞻性收集患者人口统计学、手术和术后变量的数据。主要结局是术后肠粘连,定义为在没有临床或影像学梗阻迹象的情况下,对口服食物不耐受,需要插入鼻胃管或术后第 3 天及以后出现以下两种或两种以上症状:恶心/呕吐;腹胀;以及无肛门排气。次要结局包括住院时间、耐受常规饮食的时间、首次排气或排便的时间以及总发病率。将进行成本分析,以比较常规护理与常规护理加术前刺激的成本。

讨论

本文讨论了术前肠道刺激改善术后结果的潜在益处,并概述了我们进行的第一项多中心研究方案,以评估回肠造口关闭前的术前肠道刺激。该研究的结果可能对接受回肠造口关闭的患者的护理产生重大影响。

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