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腹腔镜与腹式子宫切除术患者生活质量的比较:一项随机对照试验。

Quality of life after laparoscopic and abdominal hysterectomy: a randomized controlled trial.

机构信息

Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.

出版信息

Obstet Gynecol. 2012 Jan;119(1):85-91. doi: 10.1097/AOG.0b013e31823d3b00.

Abstract

OBJECTIVE

To report the 4-year follow-up quality-of-life data of a randomized controlled trial between abdominal and laparoscopic hysterectomy and to investigate whether any difference in quality of life would remain long-term.

METHODS

Patients scheduled for hysterectomy for benign indications were randomized and received the Dutch version of the Short Form 36 questionnaire. The Short Form 36 consists of eight domains in which 100 points can be obtained. Higher scores denote a higher quality of life. A linear mixed model was used to study the differences between the two groups up to 4 years after surgery for each of the domains and the total Short Form 36 score separately.

RESULTS

Fifty-nine patients were randomized (27 to laparoscopic hysterectomy and 32 to abdominal hysterectomy). Median follow-up after surgery was 243 weeks (range, 188-303 weeks). The overall response rate on the Short Form 36 questionnaire after 4 years was 83% (49 of 59 patients). Total Short Form 36 questionnaire scores were significantly higher in patients after laparoscopic compared with abdominal hysterectomy up to 4 years after surgery (overall mean difference 50.4 points [95% confidence interval 1.0-99.7] in favor of laparoscopic hysterectomy). Higher scores were also found on the domains physical role functioning, social role functioning, and vitality.

CONCLUSION

With a follow-up of 4 years, patients who underwent laparoscopic hysterectomy reported a better quality of life compared with abdominal hysterectomy. Therefore, patients in whom vaginal hysterectomy is not possible should be able to have a laparoscopic hysterectomy, if feasible, in terms of uterine size.

CLINICAL TRIAL REGISTRATION

ISRCTN Register, www.controlled-trials.com/isrctn, ISRCTN15214439.

摘要

目的

报告一项腹式与腹腔镜子宫切除术随机对照试验的 4 年随访生活质量数据,并探讨生活质量是否存在长期差异。

方法

将因良性疾病接受子宫切除术的患者随机分组,并接受荷兰版健康调查简表(Short Form 36)问卷。健康调查简表包含 8 个领域,每个领域满分 100 分,得分越高表示生活质量越高。使用线性混合模型分别研究两组患者在术后 4 年内每个领域和健康调查简表总分的差异。

结果

59 例患者被随机分配(腹腔镜组 27 例,腹式组 32 例)。术后中位随访时间为 243 周(188~303 周)。4 年后健康调查简表的总应答率为 83%(59 例患者中的 49 例)。腹腔镜组患者的健康调查简表总分在术后 4 年内显著高于腹式组(总体平均差值 50.4 分,95%置信区间 1.0~99.7,腹腔镜组更优)。在身体角色功能、社会角色功能和活力等领域也发现了更高的评分。

结论

随访 4 年后,行腹腔镜子宫切除术的患者生活质量优于行腹式子宫切除术的患者。因此,如果子宫大小可行,不能行阴道子宫切除术的患者应能够选择行腹腔镜子宫切除术。

临床试验注册

ISRCTN Register,www.controlled-trials.com/isrctn,ISRCTN15214439。

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