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一项由土耳其泌尿肿瘤学会进行的前瞻性随机多中心研究,比较了两种不同的机械性肠道准备方法在根治性膀胱切除术的应用。

A prospective randomized multicenter study of Turkish Society of Urooncology comparing two different mechanical bowel preparation methods for radical cystectomy.

机构信息

Department of Urology, Dokuz Eylul University School of Medicine, Izmir, Turkey.

出版信息

Urol Oncol. 2013 Jul;31(5):664-70. doi: 10.1016/j.urolonc.2011.03.009. Epub 2011 May 4.

Abstract

OBJECTIVE

To investigate the outcomes and complication rates of urinary diversion using mechanical bowel preparation (BP) with 3 day conventional and limited BP method through a standard perioperative care plan.

MATERIALS AND METHODS

This study was designed as a prospective randomized multicenter trial. All patients were randomized to 2 groups. Patients in standard 3-day BP protocol received diet restriction, oral antibiotics to bowel flora, oral laxatives, and saline enemas over a 3-day period, whereas limited the BP arm received liberal use of liquid diet, sodium phosphate laxative, and self administered enema the day before surgery. All patients received same perioperative treatment protocol. The endpoints for the assessment of outcome were anastomotic leakage, wound infection, wound dehiscence, intraperitoneal abscess, peritonitis, sepsis, ileus, reoperation, and mortality. Bowel function recovery, including time to first bowel movement, time to first oral intake, time to regular oral intake, and length of hospital stay were also assessed.

RESULTS

Fifty-six patients in 3-day BP and 56 in limited BP arm were evaluable for the study end points. Postoperatively, 1 patient in limited BP and 2 patients in 3-day BP arm died. There was no statistical difference in any of the variables assessed throughout the study, however, a favorable return of bowel function and time to discharge as well as lower complication rate were observed in limited BP group.

CONCLUSIONS

Regarding all endpoints, including septic and nonseptic complications, current clinical research offers no evidence to show any advantage of 3-day BP over limited BP.

摘要

目的

通过标准围手术期护理计划,研究使用机械肠道准备(BP)进行尿流改道的结果和并发症发生率,比较 3 天常规肠道准备和有限肠道准备方法。

材料和方法

本研究设计为前瞻性随机多中心试验。所有患者随机分为 2 组。标准 3 天 BP 方案组患者接受饮食限制、口服抗生素对肠道菌群、口服轻泻剂和生理盐水灌肠 3 天,而有限 BP 组在手术前一天接受自由使用液体饮食、磷酸钠泻药和自行灌肠。所有患者均接受相同的围手术期治疗方案。评估结果的终点是吻合口漏、伤口感染、伤口裂开、腹腔脓肿、腹膜炎、败血症、肠梗阻、再次手术和死亡率。还评估了肠道功能恢复情况,包括首次排便时间、首次口服摄入时间、常规口服摄入时间和住院时间。

结果

在 3 天 BP 组和有限 BP 组中,56 例患者可评估研究终点。术后,有限 BP 组 1 例患者和 3 天 BP 组 2 例患者死亡。在整个研究过程中,评估的所有变量均无统计学差异,但在有限 BP 组中观察到肠道功能恢复更快、出院时间更早,并发症发生率更低。

结论

关于所有终点,包括感染性和非感染性并发症,当前临床研究没有证据表明 3 天 BP 比有限 BP 有任何优势。

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