作者: Lea Laird Andersen , Bent Ottesen , Lars Mikael Alling Møller , Christian Gluud , Ann Tabor
DOI: 10.1016/J.AJOG.2014.12.039
关键词: Randomized controlled trial 、 Intention-to-treat analysis 、 Hysterectomy 、 Surgery 、 Quality of life 、 Medicine 、 Vaginal bleeding 、 Confidence interval 、 Urinary incontinence 、 Relative risk
摘要: Objective The objective of the study was to compare long-term results subtotal vs total abdominal hysterectomy for benign uterine diseases 14 years after hysterectomy, with urinary incontinence as primary outcome measure. Study Design This a follow-up multicenter, randomized clinical trial without blinding. Eleven gynecological departments in Denmark contributed participants trial. Women referred who did not have contraindications were (n = 161) 158) hysterectomy. All women enrolled from 1996 2000 still alive and living 304) invited answer validated questionnaire used prior 1 5 year follow-ups. Hospital contacts possibly related postoperatively registered discharge summaries all public hospitals Denmark. analyzed intention treat per protocol. Possible bias caused by missing data handled multiple imputation. was urinary incontinence; secondary outcomes pelvic organ prolapse, constipation, pain, sexuality, quality life (Short Form-36 questionnaire), hospital contacts, vaginal bleeding. Results answered 197 304 (64.8%) (subtotal [n = 97] [63.4%]; 100] [66.2%]). Mean time mean age at 60.1 years. After 32 97 (33%) complained compared 20 100 (20%) (relative risk, 1.67; 95% confidence interval, 1.02–2.70; P = .035). imputation analysis, this difference disappeared 1.36; 0.86–2.13; .19). No differences seen any outcomes. Conclusion Subtotal superior on More seem subjective result confirmed analysis should be interpreted cautiously.