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前瞻性切换研究比较两种用于儿童经肛门灌洗的冲洗系统。

Prospective switch study comparing two irrigation systems for transanal irrigation in children.

机构信息

Ghent University Hospital, Pediatric Surgery, Ghent, Belgium.

Ghent University Hospital, Pediatric Gastroenterology, Ghent, Belgium.

出版信息

Acta Gastroenterol Belg. 2021 Apr-Jun;84(2):295-298. doi: 10.51821/84.2.295.

Abstract

BACKGROUND AND STUDY AIMS

Transanal irrigation (TAI) is used in children to treat constipation and incontinence. Belgium has 2 systems available: Colotip® (cheaper, however not designed for TAI) or Peristeen®.

PATIENTS AND METHODS

This patient-control switch study is the first to compare 2 TAI systems. Children regularly using Colotip® for TAI were asked to participate, after consent, a visual analogue scale (VAS) rating the system and a 2-week diary (fecal continence, self-reliance, time spent on the toilet, pain, Bristol stool scale, irrigation volume and frequency of enema) were completed. Non-parametric statistics were used.

RESULTS

Out of 26 children using Colotip®, 18 (69%) children participated and 5 refused (fear n=1, satisfaction Colotip® system n=7). Of these 18 children (interquartile range: 3-18 years, median 12.5 years, 9 girls) 5 patients stopped Peristeen® (pain n=1, fear n=1 and balloon loss n=3) and 2 were lost from follow up. Dropouts and included patients showed no statistical difference. In the 11 remaining patients, pseudo-continence (p 0.015), independence (p 0.01) and VAS score (p 0.007) were significantly better with Peristeen®, no difference was found in time spent on the toilet (p 0.288) and presence of pain (p 0.785).

CONCLUSIONS

In children Peristeen® offered significantly higher pseudo-continence and independency. 30% refused participation because of satisfaction with the Colotip® and 30% spina bifida patients reported rectal balloon loss due to sphincter hypotony. To diminish Peristeen® failure, a test-catheter could be of value. Considering Colotip® satisfaction, both systems should be available. Patient selection for Peristeen® needs further research.

摘要

背景和研究目的

经肛门灌洗(TAI)用于治疗儿童便秘和失禁。比利时有两种系统可用:Colotip®(更便宜,但不是为 TAI 设计的)或 Peristeen®。

患者和方法

这是第一项比较两种 TAI 系统的患者对照转换研究。经常使用 Colotip®进行 TAI 的儿童在同意后被要求参与,他们对系统进行视觉模拟评分(VAS),并填写两周的日记(粪便节制、自理、在厕所花费的时间、疼痛、布里斯托粪便量表、冲洗量和灌肠频率)。使用非参数统计。

结果

在 26 名使用 Colotip®的儿童中,18 名(69%)儿童参与,5 名拒绝(1 名因害怕,7 名对 Colotip®系统满意)。这 18 名儿童(四分位距:3-18 岁,中位数 12.5 岁,9 名女孩)中有 5 名停止使用 Peristeen®(1 名因疼痛,1 名因害怕,3 名因球囊丢失),2 名失访。退出者和入选者之间没有统计学差异。在其余 11 名患者中,使用 Peristeen®的假性节制(p<0.015)、独立性(p<0.01)和 VAS 评分(p<0.007)显著更好,在厕所花费的时间(p<0.288)和疼痛的存在(p<0.785)方面无差异。

结论

在儿童中,Peristeen®提供了更高的假性节制和独立性。30%的儿童因对 Colotip®的满意度而拒绝参与,30%的脊髓裂儿童因括约肌张力低下而报告直肠球囊丢失。为了减少 Peristeen®的失败,测试导管可能是有价值的。考虑到 Colotip®的满意度,两种系统都应该可用。对 Peristeen®的患者选择需要进一步研究。

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