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温水坐浴与低水压电子坐浴盆用于痔切除术后管理的比较(BIDLOW)

Comparison of warm sitz bath and electronic bidet with a lower-force water flow for postoperative management after hemorrhoidectomy (BIDLOW).

作者信息

Kwon Yoon-Hye, Ryoo Seung-Bum, Oh Heung-Kwon, Lee Jae Bum, Jung Hyung-Joong, Song Kee-Ho, Heo Seung Chul, Shin Rumi, Lee Joongyub, Park Kyu Joo

机构信息

Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.

Department of Surgery, Uijeongbu Eulji Medical Center, Uijeongbu City, Korea.

出版信息

BMC Surg. 2025 Jan 6;25(1):5. doi: 10.1186/s12893-024-02737-0.

Abstract

AIM

Electronic bidets can be a substitute for sitz baths, but no study has examined the use of electronic bidets to manage anal problems.

METHODS

A randomized, controlled, single-blind, multicenter, parallel group trial was performed. Patients who underwent hemorrhoidectomy were randomly assigned (1:1) to use the electronic bidet or warm sitz baths for 7 days after hemorrhoidectomy. The primary endpoint was the difference in the anal pain VAS score for 7 days posthemorrhoidectomy.

RESULTS

Patients were assigned to the electronic bidet (51) or sitz bath (50) groups. Twenty-six patients dropped out after randomization, and the final analysis included 34 patients in the electronic bidet group and 41 in the sitz bath group. The VAS score for anal pain 7 days posthemorrhoidectomy did not differ between the electronic bidet and sitz bath groups (38.3 ± 21.9 vs. 42.0 ± 21.1, p = 0.453). The upper limit of the 95% confidence interval of the VAS score in the electronic bidet group (81.22) was greater than the margin of noninferiority (46.20).

CONCLUSION

The VAS scores after hemorrhoidectomy did not differ between the electronic bidet and sitz bath groups, but the noninferiority of the electronic bidet to sitz baths for anal pain 7 days posthemorrhoidectomy was not verified.

TRIAL REGISTRATION

The trial was registered on ClinicalTrials.gov (Registration number: NCT02353156, date: 02/02/2015).

摘要

目的

电子坐浴盆可替代坐浴,但尚无研究探讨其在处理肛门问题方面的应用。

方法

开展一项随机、对照、单盲、多中心、平行组试验。接受痔切除术的患者在术后7天被随机(1:1)分配使用电子坐浴盆或温水坐浴。主要终点为痔切除术后7天的肛门疼痛视觉模拟评分(VAS)差异。

结果

患者被分配至电子坐浴盆组(51例)或坐浴组(50例)。随机分组后有26例患者退出,最终分析纳入电子坐浴盆组34例患者和坐浴组41例患者。痔切除术后7天,电子坐浴盆组和坐浴组的肛门疼痛VAS评分无差异(38.3±21.9 vs. 42.0±21.1,p = 0.453)。电子坐浴盆组VAS评分的95%置信区间上限(81.22)大于非劣效界值(46.20)。

结论

痔切除术后电子坐浴盆组和坐浴组的VAS评分无差异,但电子坐浴盆在痔切除术后7天对肛门疼痛的非劣效性未得到验证。

试验注册

该试验在ClinicalTrials.gov上注册(注册号:NCT02353156,日期:2015年2月2日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/00b6/11702218/7238f7ea82d9/12893_2024_2737_Fig1_HTML.jpg

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