良性/恶性疾病腹腔镜子宫切除术后当天出院:多中心随机对照试验。

IF 4.7 1区 医学 Q1 OBSTETRICS & GYNECOLOGY
Suzanne J Dedden, Jacques W M Maas, Nicol A C Smeets, Dennis van Hamont, Freek A Groenman, Arianne C Lim, Huib A A M van Vliet, Jan Willem van der Steeg, Jaklien C Leemans, Patrick Meijer, Sander M J van Kuijk, Judith A F Huirne, Marlies Y Bongers, Peggy M A J Geomini
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引用次数: 0

摘要

目的:评估全腹腔镜子宫切除术后当天出院是否会影响身体功能和生活质量:评估全腹腔镜子宫切除术后当天出院是否会影响身体功能和生活质量:多中心非劣效性随机对照试验:人群: 接受腹腔镜子宫切除术的患者:人群: 因良性或恶性前疾病接受腹腔镜子宫切除术的患者:在获得知情同意后,参与者按1:1分配至当日出院(SDD)或次日出院(NDD):主要结果是术后7天的身体功能,由患者报告结果测量信息系统(PROMIS)身体功能简表10A测量。次要结果是术后 1 天、3 天和 6 周的身体功能和生活质量,采用 PROMIS 短表 10A 和 EuroQol 问卷(EQ-5D-5L)进行测量:结果:共纳入 255 名患者,其中 105 人被分配到 SDD,100 人被分配到 NDD。术后 7 天,SDD 组的身体功能为 35.95,对照组为 35.63(平均差异为 0.32;95% CI [0.07-0.57])。由于 95% CI 的上限未超过 4 分的非劣效边距,因此 SDD 的非劣效性得以证实。第1天、第3天和第6周的身体功能和生活质量均无差异:这项研究表明,腹腔镜子宫切除术后当日出院在术后 7 天的身体功能方面不劣于次日出院。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Same-day discharge after laparoscopic hysterectomy for benign/premalignant disease: A multicentre randomised controlled trial.

Objective: To evaluate whether physical function and quality of life was influenced by discharge on the same-day after a total laparoscopic hysterectomy.

Design: Multicentre non-inferiority randomised controlled trial.

Setting: Five teaching hospitals and two university hospitals in the Netherlands.

Population: Patients undergoing laparoscopic hysterectomy for benign or premalignant disease.

Methods: Following informed consent, participants were allocated 1:1 either to same-day discharge (SDD) or next-day discharge (NDD).

Main outcome measures: The primary outcome was physical function at 7 days after surgery measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function short Form 10A. Secondary outcomes were physical function and quality of life at 1 and 3 days and 6 weeks after surgery measured with PROMIS short Form 10A and the EuroQol questionnaire (EQ-5D-5L).

Results: Two hundred and five patients were included of whom 105 were allocated to SDD and 100 to NDD. Physical function 7 days after surgery was 35.95 in the SDD group and 35.63 in the control group (mean difference 0.32; 95% CI [0.07-0.57]). As the upper limit of the 95% CI does not exceed the non-inferiority margin of 4 points, non-inferiority of SDD could be demonstrated. No difference in physical function nor quality of life on Days 1 and 3 and 6 weeks could be found.

Conclusion: This research demonstrates same-day discharge after laparoscopic hysterectomy is non-inferior to next day discharge in physical function 7 days after surgery.

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来源期刊
CiteScore
10.90
自引率
5.20%
发文量
345
审稿时长
3-6 weeks
期刊介绍: BJOG is an editorially independent publication owned by the Royal College of Obstetricians and Gynaecologists (RCOG). The Journal publishes original, peer-reviewed work in all areas of obstetrics and gynaecology, including contraception, urogynaecology, fertility, oncology and clinical practice. Its aim is to publish the highest quality medical research in women''s health, worldwide.
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