Randomised controlled trial of total compared with subtotal hysterectomy with one-year follow up results

Objective To compare total abdominal hysterectomy and subtotal abdominal hysterectomy performed for benign uterine diseases. Design Randomised, controlled, unblinded trial with central, computer-generated randomisation. Setting Danish trial performed in 11 departments of gynaecology. Population Women referred for benign uterine diseases were randomised to total abdominal hysterectomy (n = 158) or subtotal abdominal hysterectomy (n = 161). One-year follow up questionnaires had a response rate of 87%. Methods Patients were followed by strict data collection procedures, including postal questionnaires. The results after one year of follow up were analysed by intention-to-treat analyses. Main outcome measures (1) Primary: urinary incontinence and (2) secondary: post-operative complications, quality of life (SF-36), constipation, prolapse of the vaginal vault/cervical stump, satisfaction with sexual life, pelvic pain and vaginal bleeding. Results A significantly (P = 0.043) smaller proportion of women bad urinary incontinence one year after total abdominal hysterectomy compared with subtotal abdominal hysterectomy [9% vs 18% (OR 2.08, 95% CI 1.01-4.29)]. The lower proportion of incontinent women in the total abdominal hysterectomy group was a result of a higher proportion of symptom relief (total abdominal hysterectomy: 20/140, subtotal abdominal hysterectomy: 14/136) as well as a lower proportion of women with new symptoms (total abdominal hysterectomy: 3/140, subtotal abdominal hysterectomy: 10/137). Twenty-seven women (20%) from the subtotal abdominal hysterectomy group had vaginal bleeding and two of them had to have their cervix removed. No other clinically important differences were found between the two hysterectomy methods. Conclusions A smaller proportion of women suffered from urinary incontinence after total abdominal hysterectomy than after subtotal abdominal hysterectomy one year post-operatively.