研究动态
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腹腔镜子宫切除术治疗良性/癌前疾病后当天出院:一项多中心随机对照试验。

Same-day discharge after laparoscopic hysterectomy for benign/premalignant disease: A multicentre randomised controlled trial.

发表日期:2024 Jul 17
作者: 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
来源: Bjog-Int J Obstet Gy

摘要:

评估全腹腔镜子宫切除术后当天出院是否影响身体功能和生活质量。多中心非劣效性随机对照试验。荷兰五家教学医院和两所大学医院。接受腹腔镜子宫切除术的良性或癌前疾病。在知情同意后,参与者按 1:1 的比例分配为当天出院 (SDD) 或次日出院 (NDD)。主要结果是术后 7 天的身体功能,通过患者报告的结果测量信息进行测量系统 (PROMIS) 物理功能简表 10A。次要结果是使用 PROMIS 简表 10A 和 EuroQol 问卷 (EQ-5D-5L) 测量术后 1、3 天和 6 周的身体功能和生活质量。 纳入了 205 名患者,其中 105 名被分配到SDD 和 100 至 NDD。术后7天的身体功能SDD组为35.95,对照组为35.63(平均差0.32;95% CI [0.07-0.57])。由于95% CI的上限不超过4分的非劣效性界限,因此可以证明SDD的非劣效性。第 1 天、第 3 天和第 6 周的身体功能和生活质量没有差异。这项研究表明,腹腔镜子宫切除术后当天出院的身体功能并不劣于手术后 7 天的第二天出院。© 2024作者。 BJOG:约翰·威利出版的国际妇产科杂志
To evaluate whether physical function and quality of life was influenced by discharge on the same-day after a total laparoscopic hysterectomy.Multicentre non-inferiority randomised controlled trial.Five teaching hospitals and two university hospitals in the Netherlands.Patients undergoing laparoscopic hysterectomy for benign or premalignant disease.Following informed consent, participants were allocated 1:1 either to same-day discharge (SDD) or next-day discharge (NDD).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).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.This research demonstrates same-day discharge after laparoscopic hysterectomy is non-inferior to next day discharge in physical function 7 days after surgery.© 2024 The Author(s). BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.