Five-year follow up of a randomised controlled trial comparing subtotal with total abdominal hysterectomy

Objectives: 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.

Design: Randomised clinical trial with central, computer-generated randomisation.

Setting: Danish multi-centre trial performed in 11 departments of gynaecology.

Population: Women referred with benign uterine diseases scheduled for abdominal hysterectomy.

Methods: 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.

Main outcome measures: 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.

Results: 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.