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Subtotal versus total abdominal hysterectomy: randomized clinical trial with 14-year questionnaire follow-up

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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OBJECTIVE: To compare long-term results of subtotal versus total abdominal hysterectomy for benign uterine diseases 14 years after hysterectomy, with urinary incontinence as primary outcome measure.

STUDY DESIGN: Long-term follow-up of a multi-center 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) versus 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 one- and five-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 (SF-36 questionnaire), hospital contacts, and vaginal bleeding.

RESULTS: The questionnaire was answered by 197/304 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 32/97 (33%) women complained of urinary incontinence compared with 20/100 (20%) women after total abdominal hysterectomy 14 years after hysterectomy (relative risk 1.67, 95% confidence interval 1.02 to 2.70, P=0.035). After multiple imputation analysis this difference disappeared (relative risk 1.36, 95% confidence interval 0.86-2.13, P= 0.19). 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.

OriginalsprogEngelsk
TidsskriftAmerican Journal of Obstetrics and Gynecology
Vol/bind212
Udgave nummer6
Sider (fra-til)758.e1-758.e54
ISSN0002-9378
DOI
StatusUdgivet - 2015

ID: 44827594