Antoun Lina, Woolley Rebecca, Middleton Lee, Smith Paul, Saridogan Ertan, Cooper Kevin, McKinnon William, Bevan Sheriden, Ziomek Kamila, Sairally Zeyah, Jones Laura, Fullard Jayne, Morgan Monique, Clark T Justin
Birmingham Women's and Children's Hospitals NHS Foundation Trust, Birmingham, UK
Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, West Midlands, UK.
BMJ Open. 2025 Jun 5;15(6):e096265. doi: 10.1136/bmjopen-2024-096265.
To compare recovery after laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH).
A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial.
10 NHS (National Health Service) hospitals within the UK.
Women undergoing hysterectomy for a benign gynaecological condition.
Consenting women of 18-55 years were randomised to LH or AH using a secure internet facility by a surgeon with self-declared expertise. Major complications were recorded by clinicians, and recovery was assessed by regular text messaging and postal questionnaires.
Major surgical complications (Clavien-Dindo≥level 3) up to six completed weeks postsurgery, time to resumption of normal activities measured by the Patient-Reported Outcomes Measurement Information System Physical Function tool and quality of recovery at 24 hours (Quality of Recovery 15 score; 0-150).
75 women were randomised before early curtailment of the trial; 32/39 (82%) and 30/36 (83%) women underwent LH and AH, respectively. Major complications occurred in 2/32 (6%) LH versus 4/30 (13%) AH groups. No difference in time to resumption of usual activities was found (median [IQR, n] 7.5 weeks (3.6-8.2, 25) LH vs 7.5 weeks (5.5-10.6, 26) AH groups or quality of recovery (mean [SD, n] 81.1 (13.4, 27) vs 72.3 (17.6, 22), respectively; adjusted mean difference 7.2, 95% CI -3.2 to 17.6).
No differences were found in complications or recovery between LH and AH. However, early cessation of the trial due to recruitment challenges limits clinical inferences. It is important that larger comparative trials are conducted now that LH, including robotics, is becoming adopted as standard practice.
ISRCTN14566195, IRAS ID 287988.
比较腹腔镜子宫切除术（LH）和腹式子宫切除术（AH）后的恢复情况。
一项平行、开放、非劣效性、多中心、随机对照、基于专业技能的手术试验。
英国的10家国民保健服务（NHS）医院。
因良性妇科疾病接受子宫切除术的女性。
年龄在18至55岁之间且同意参与的女性，由自称具备专业技能的外科医生通过安全的互联网设施随机分配接受LH或AH手术。临床医生记录主要并发症，并通过定期短信和邮寄问卷评估恢复情况。
术后六周内的主要手术并发症（Clavien-Dindo≥3级）；采用患者报告结局测量信息系统身体功能工具测量恢复正常活动的时间；术后24小时的恢复质量（恢复质量15评分；0至150分）。
在试验提前终止前，75名女性被随机分组；分别有32/39（82%）和30/36（83%）的女性接受了LH和AH手术。LH组2/32（6%）与AH组4/30（13%）发生了主要并发症。恢复正常活动的时间未发现差异（LH组中位数[四分位间距，n]为7.5周（3.6 - 8.2，25），AH组为7.5周（5.5 - 10.6，26）），恢复质量也无差异（均值[标准差，n]分别为81.1（13.4，27）和72.3（17.6，22）；调整后均值差异为7.2，95%置信区间为 -3.2至17.6）。
LH和AH在并发症或恢复方面未发现差异。然而，由于招募困难导致试验提前终止，限制了临床推断。鉴于LH（包括机器人辅助手术）正逐渐成为标准术式，开展更大规模的对比试验很重要。
ISRCTN14566195，IRAS识别号287988。
