Andersen L L, Zobbe V, Ottesen B, Gluud C, Tabor A, Gimbel H
Department of Obstetrics and Gynaecology, Nykøbing Falster Hospital, Nykøbing Falster, Denmark.
Department of Obstetrics and Gynaecology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
BJOG. 2015 May;122(6):851-857. doi: 10.1111/1471-0528.12914. Epub 2014 Jun 11.
To compare the rates of urinary incontinence (UI) and other complications of subtotal abdominal hysterectomy (SAH) with total abdominal hysterectomy (TAH) at 5 years after surgery.
Randomised clinical trial with central, computer-generated randomisation.
Danish multi-centre trial performed in 11 departments of gynaecology.
Women referred with benign uterine diseases scheduled for abdominal hysterectomy.
Women were randomised to either SAH (n = 161) or TAH (n = 158). Follow-up data were collected from participants using postal questionnaires sent out 5 years after surgery. Complications of hysterectomy were further examined by scrutinising registered discharge summaries following hospitalisation. Intention-to-treat and per-protocol analyses were conducted. Potential bias caused by missing data was handled using multiple imputation.
The primary outcome was UI. Secondary outcomes included constipation, prolapse of the vaginal vault or cervical stump, satisfaction with sexual life, pelvic pain, postoperative complications and vaginal bleeding.
The response rate was 234/319 (73.4%). A significantly higher proportion of respondents had urinary incontinence 5 years after SAH 34/113 (30.1%) than TAH 21/119 (17.6%) (RR 1.71, 95% confidence interval 1.06-2.75, P = 0.026). This difference reduced after multiple imputation to account for missing data (RR 1.37, 95% confidence interval 0.99-1.89, P = 0.052). Eleven of the 101 women (11%) in the SAH group still experienced vaginal bleeding. No other differences were found between the two types of abdominal hysterectomy.
AUTHORS' CONCLUSIONS: A smaller proportion of women suffered from UI after TAH than after SAH 5 years postoperatively. Around one in ten women continued to experience vaginal bleeding 5 years after SAH.
比较腹式子宫次全切除术（SAH）与腹式全子宫切除术（TAH）术后5年尿失禁（UI）及其他并发症的发生率。
采用中央计算机生成随机数的随机临床试验。
在丹麦11个妇科科室进行的多中心试验。
因良性子宫疾病计划行腹式子宫切除术的女性。
将女性随机分为SAH组（n = 161）或TAH组（n = 158）。术后5年通过邮寄问卷收集参与者的随访数据。通过仔细审查住院后的出院记录摘要，进一步检查子宫切除术的并发症。进行意向性分析和符合方案分析。使用多重填补法处理缺失数据导致的潜在偏倚。
主要结局为尿失禁。次要结局包括便秘、阴道穹窿或宫颈残端脱垂、性生活满意度、盆腔疼痛、术后并发症和阴道出血。
回复率为234/319（73.4%）。SAH术后5年尿失禁的受访者比例34/113（30.1%）显著高于TAH术后的21/119（17.6%）（RR 1.71，95%置信区间1.06 - 2.75，P = 0.026）。在多重填补法处理缺失数据后，这种差异减小（RR 1.37，95%置信区间0.99 - 1.89，P = 0.052）。SAH组101名女性中有11名（11%）仍有阴道出血。两种腹式子宫切除术之间未发现其他差异。
术后5年，TAH术后发生尿失禁的女性比例低于SAH术后。SAH术后5年约十分之一的女性仍有阴道出血。
