Lea Laird Andersen1, Bent Ottesen2, Lars Mikael Alling Møller3, Christian Gluud4, Ann Tabor5, Vibeke Zobbe5, Elise Hoffmann3, Helga Margrethe Gimbel6. 1. Department of Obstetrics and Gynecology, Nykøbing Falster Hospital, Nykøbing Falster in association with the University of Southern Denmark, Denmark. Electronic address: lland@regionsjaelland.dk. 2. Juliane Marie Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 3. Department of Obstetrics and Gynecology, Roskilde Hospital, Roskilde, Denmark. 4. Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 5. Department of Obstetrics and Gynecology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 6. Department of Obstetrics and Gynecology, Nykøbing Falster Hospital, Nykøbing Falster in association with the University of Southern Denmark, Denmark.
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. STUDY DESIGN: 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. CONCLUSION: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.
RCT Entities:
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. STUDY DESIGN: 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. CONCLUSION: 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: Gabriel Francisco Aleixo; Marcelo C M Fonseca; Maria Augusta Tezelli Bortolini; Luiz Gustavo O Brito; Rodrigo A Castro Journal: Int Urogynecol J Date: 2018-11-22 Impact factor: 2.894