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腹部按摩预防结直肠手术后肠麻痹:一项单中心前瞻性随机临床试验:MATRAC 试验。

Abdominal massage to prevent ileus after colorectal surgery. A single-center, prospective, randomized clinical trial: the MATRAC Trial.

机构信息

University Grenoble Alpes, CNRS, Grenoble INP, TIMC, UMR 5525, VetAgro Sup, 38000, Grenoble, France.

Colorectal Surgery Unit, Department of Digestive and Emergency Surgery, Grenoble Alpes University Hospital, CS 10217, 38043, Grenoble Cedex, France.

出版信息

Tech Coloproctol. 2024 Mar 22;28(1):42. doi: 10.1007/s10151-024-02914-6.

DOI:10.1007/s10151-024-02914-6
PMID:38517591
Abstract

BACKGROUND

There is scarce literature on the effect of mechanical abdominal massage on the duration of ileus after colectomy, particularly in the era of enhanced recovery after surgery (ERAS). The aim of this study was to determine whether abdominal massage after colorectal surgery with anastomosis and no stoma helps toward a faster return of intestinal transit.

METHODS

This study was a superiority trial and designed as a prospective open-label, single-center, randomized controlled clinical trial with two parallel groups. Patients scheduled to undergo intestinal resection and follow an ERAS protocol were randomly assigned to either the standard ERAS group or the ERAS plus massage group. The primary endpoint was the return of intestinal transit, defined as the first passage of flatus following the operation. Secondary endpoints included time of the first bowel motion, maximal pain, 30 day complications, complications due to massage, anxiety score given by the Hospital Anxiety and Depression (HAD) questionnaire, and quality of life assessed by the EQ-5D-3L questionnaire.

RESULTS

Between July 2020 and June 2021, 36 patients were randomly assigned to the ERAS group or the ERAS plus massage group (n = 19). Patients characteristics were comparable. There was no significant difference in time to passage of the first flatus between the ERAS group and the ERAS plus abdominal massage group (1065 versus 1389 min, p = 0.274). No statistically significant intergroup difference was noted for the secondary endpoints.

CONCLUSION

Our study, despite its limitations, failed to demonstrate any advantage of abdominal massage to prevent or even reduce symptoms of postoperative ileus after colorectal surgery.

TRIAL REGISTRATION NUMBER

38RC20.021.

摘要

背景

关于机械腹部按摩对结肠切除术后肠麻痹持续时间的影响,尤其是在术后加速康复(ERAS)时代,文献报道较少。本研究旨在确定结直肠手术后吻合且无造口的患者进行腹部按摩是否有助于更快恢复肠道蠕动。

方法

本研究为优效性试验,设计为前瞻性开放标签、单中心、随机对照临床试验,两组平行。计划行肠道切除术并遵循 ERAS 方案的患者被随机分配至标准 ERAS 组或 ERAS 加按摩组。主要终点为肠道蠕动恢复,定义为术后首次排气。次要终点包括首次排便时间、最大疼痛、30 天并发症、按摩相关并发症、医院焦虑抑郁量表(HAD)评分焦虑、EQ-5D-3L 问卷评估的生活质量。

结果

2020 年 7 月至 2021 年 6 月,36 例患者被随机分配至 ERAS 组或 ERAS 加腹部按摩组(n=19)。患者特征具有可比性。ERAS 组与 ERAS 加腹部按摩组首次排气时间无显著差异(1065 分钟比 1389 分钟,p=0.274)。次要终点也未见组间统计学差异。

结论

尽管存在局限性,但本研究未能证明腹部按摩在预防结直肠手术后肠麻痹方面具有任何优势,甚至无法减轻术后肠麻痹的症状。

临床试验注册号

38RC20.021。

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