title: Subtotal versus total abdominal hysterectomy: randomized clinical trial with 14-year questionnaire follow-up.
abstract: OBJECTIVE
  The objective of the study was to compare long-term results of subtotal vs total abdominal hysterectomy for benign uterine diseases 14 years after hysterectomy, with urinary incontinence as the primary outcome measure.
  
  
  METHODS
  This was a long-term follow-up of a multicenter, randomized clinical trial without blinding. Eleven gynecological departments in Denmark contributed participants to the trial. Women referred for benign uterine diseases who did not have contraindications to subtotal abdominal hysterectomy were randomized to subtotal (n = 161) vs total (n = 158) abdominal hysterectomy. All women enrolled in the trial from 1996 to 2000 who were still alive and living in Denmark (n = 304) were invited to answer the validated questionnaire used in prior 1 and 5 year follow-ups. Hospital contacts possibly related to hysterectomy from 5 to 14 years postoperatively were registered from discharge summaries from all public hospitals in Denmark. The results were analyzed as intention to treat and per protocol. Possible bias caused by missing data was handled by multiple imputation. The primary outcome was urinary incontinence; the secondary outcomes were pelvic organ prolapse, constipation, pain, sexuality, quality of life (Short Form-36 questionnaire), hospital contacts, and vaginal bleeding.
  
  
  RESULTS
  The questionnaire was answered by 197 of 304 women (64.8%) (subtotal hysterectomy [n = 97] [63.4%]; total hysterectomy [n = 100] [66.2%]). Mean follow-up time was 14 years and mean age at follow-up was 60.1 years. After subtotal abdominal hysterectomy, 32 of 97 women (33%) complained of urinary incontinence compared with 20 of 100 women (20%) after total abdominal hysterectomy 14 years after hysterectomy (relative risk, 1.67; 95% confidence interval, 1.02-2.70; P = .035). After a multiple imputation analysis, this difference disappeared (relative risk, 1.36; 95% confidence interval, 0.86-2.13; P = .19). No differences were seen in any of the secondary outcomes.
  
  
  CONCLUSIONS
  Subtotal abdominal hysterectomy was not superior to total abdominal hysterectomy on any outcomes. More women seem to have subjective urinary incontinence 14 years after subtotal abdominal hysterectomy. This result was not confirmed by multiple imputation analysis and should be interpreted cautiously.
authors.affiliation: Department of Obstetrics and Gynecology, Nykøbing Falster Hospital, Nykøbing Falster in association with the University of Southern Denmark, Denmark. Electronic address: lland@regionsjaelland.dk.
authors.forename: Lea Laird
authors.initials: LL
authors.lastname: Andersen
authors.affiliation: Juliane Marie Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Bent
authors.initials: B
authors.lastname: Ottesen
authors.affiliation: Department of Obstetrics and Gynecology, Roskilde Hospital, Roskilde, Denmark.
authors.forename: Lars Mikael
authors.initials: LM
authors.lastname: Alling Møller
authors.affiliation: Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.affiliation: Department of Obstetrics and Gynecology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Ann
authors.initials: A
authors.lastname: Tabor
authors.affiliation: Department of Obstetrics and Gynecology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Zobbe
authors.affiliation: Department of Obstetrics and Gynecology, Roskilde Hospital, Roskilde, Denmark.
authors.forename: Elise
authors.initials: E
authors.lastname: Hoffmann
authors.affiliation: Department of Obstetrics and Gynecology, Nykøbing Falster Hospital, Nykøbing Falster in association with the University of Southern Denmark, Denmark.
authors.forename: Helga Margrethe
authors.initials: HM
authors.lastname: Gimbel
mesh_terms: D000005:Abdomen; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007044:Hysterectomy / Q000379:methods*; D008875:Middle Aged; D011795:Surveys and Questionnaires; D013997:Time Factors; D014591:Uterine Diseases / Q000601:surgery*
keywords: hysterectomy; long-term follow-up; pelvic organ prolapse; quality of life; urinary incontinence