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造口棒在回肠袢式造口术中用于弥补肠管回缩是否有用?一项随机对照试验。

Is An Ostomy Rod Useful for Bridging the Retraction During the Creation of a Loop Ileostomy? A Randomized Control Trial.

作者信息

Uchino Motoi, Ikeuchi Hiroki, Bando Toshihiro, Chohno Teruhiro, Sasaki Hirofumi, Horio Yuki

机构信息

Department of Inflammatory Bowel Disease, Hyogo College of Medicine, Nishinomiya, Japan.

出版信息

World J Surg. 2017 Aug;41(8):2128-2135. doi: 10.1007/s00268-017-3978-7.

Abstract

BACKGROUND

A loop ileostomy is generally created during restorative proctocolectomy (RPC) for treating ulcerative colitis (UC), and an ostomy rod is often used to prevent stoma retraction. However, its usefulness or harmfulness has not been proven. We performed a prospective randomized control study to investigate the non-inferiority of ostomy creation without a rod to prevent stoma retraction.

METHODS

Patients with UC who underwent RPC were enrolled and randomly divided into groups either with or without ostomy rod use. Incidences of stoma retraction and dermatitis were compared.

RESULTS

Of the 320 patients in the study groups, 308 qualified for the intention-to-treat (ITT) analysis, and 257 were included in the per-protocol (PP) analysis. Ostomy retraction was recognized in 6 patients, 3 with a rod and 3 without. The difference with rod use (95% confidence interval) was 0.1 (-2.9 to 3.1)% in the PP analysis and 0.0 (-2.2 to 2.2)% in the ITT analysis. There were no significant differences in stoma retraction regardless of whether an ostomy rod was used in either analysis. Dermatitis was more common in patients with rod use (84/154) than in those without (40/154) (p < 0.01).

CONCLUSIONS

Although median body mass indices were extremely low (20 kg/m), an ostomy rod is not routinely needed as it may increase the risk of dermatitis. However, results in obese patients may differ from those shown here, which should be clarified via further studies.

摘要

背景

在治疗溃疡性结肠炎(UC)的直肠结肠切除术后重建术(RPC)期间通常会创建回肠造口术,并且经常使用造口棒来防止造口回缩。然而,其有效性或危害性尚未得到证实。我们进行了一项前瞻性随机对照研究,以调查不使用造口棒造口术在防止造口回缩方面的非劣效性。

方法

纳入接受RPC的UC患者,并随机分为使用或不使用造口棒的组。比较造口回缩和皮炎的发生率。

结果

研究组的320例患者中,308例符合意向性分析(ITT),257例纳入符合方案分析(PP)。6例患者出现造口回缩,3例使用造口棒,3例未使用。在PP分析中,使用造口棒的差异(95%置信区间)为0.1(-2.9至3.1)%,在ITT分析中为0.0(-2.2至2.2)%。在任何一项分析中,无论是否使用造口棒,造口回缩均无显著差异。使用造口棒的患者中皮炎更常见(84/154),而未使用造口棒的患者中皮炎较少见(40/154)(p<0.01)。

结论

尽管中位体重指数极低(20kg/m),但造口棒并非常规需要,因为它可能会增加皮炎风险。然而,肥胖患者的结果可能与本文所示不同,这应通过进一步研究加以阐明。

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