Helga Gimbel

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.

Sexuality after total vs. subtotal hysterectomy.

Background.  The effect of hysterectomy on sexuality is not fully elucidated and until recently total and subtotal hysterectomies have only been compared in observational studies.

Total or subtotal hysterectomy for benign uterine diseases? A meta-analysis

Background. Total and subtotal abdominal hysterectomy for benign indications have been compared in randomized clinical trials and observational studies. A meta‐analysis is performed to summarize the evidence. Methods. Thirty‐four randomized clinical trials and observational studies comparing total and subtotal abdominal hysterectomy for benign indications were included. Endpoints were self‐reported urinary incontinence, postoperative complications, operation time, quality of life, constipation, prolapse, sexual functioning, pelvic pain, and cervical stump problems after subtotal hysterectomy. Odds ratios and tests for heterogeneity and overall effect were calculated. Results. Urinary incontinence and prolapse showed a significant difference favoring the total hysterectomy. Some of the women having a subtotal hysterectomy had cervical stump problems (bleeding and abnormal smear). Operation time and peroperative bleeding are postoperative complications were significantly in favor of the subtotal hysterectomy. Lower urinary tract symptoms other than incontinence, quality of life, constipation, pelvic pain, and sexual life were not in favor of either of the hysterectomy methods. Conclusion. Less women suffered from urinary incontinence and prolapse and cervical stump problems after total than after subtotal hysterectomy. However, subtotal hysterectomy is faster to perform, has less peroperative bleeding, and seems to have less intra‐ and postoperative complications.

Hysterectomy in Denmark 1977-2011: changes in rate, indications, and hospitalization

OBJECTIVE To describe conditions regarding hysterectomy for benign indications during the past 35 years in Denmark. STUDY DESIGN Population-based register study of 167,802 women who underwent hysterectomy for benign conditions in the period 1977-2011. Patient data regarding operative techniques, hospitalization, indications, patient age, and geography were extracted from the Danish National Patient Register. RESULTS The overall rate of hysterectomy was around 180/100,000 woman years during the period. A rise in laparoscopic and vaginal hysterectomy was seen at the expense of abdominal hysterectomy. The indication of pelvic organ prolapse and abnormal uterine bleeding increased while the indication of fibroids decreased. The average age of women at time of hysterectomy increased from 46 years in 1977-1981 to 50 years in 2006-2011. The mean number of hospitalization days was reduced by 75%. Regional differences were detected regarding route of hysterectomy and hospitalization. CONCLUSIONS This study demonstrates a change in the pattern of indications for hysterectomy, increased age of the affected women, reduced length of stay in the hospital, and a rise in the percentage of minimal invasive surgical procedures.

Use of vaginal hysterectomy in Denmark: rates, indications and patient characteristics

Objective. To describe the use of vaginal, abdominal and laparoscopic hysterectomy in Denmark from 1999 to 2008, the influence of national guidelines and the patient and procedure‐related characteristics associated with the choice of vaginal hysterectomy. Design. Nationwide register‐based cohort study. Setting. Danish Hysterectomy Database and Danish National Patient Registry. Population. All women with a hysterectomy for benign indications in Denmark from 1999 to 2008. Methods. The incidence rate/100 000 women was used to describe the route of surgery in hysterectomies of 50 755 women. A multiple logistic regression analysis was done to examine the association between patient‐ and procedure‐related characteristics and choice of surgical procedure including 20 486 women. Main outcome measures. Trends in surgical approach from 1999 to 2008. Patient‐ and surgery‐related characteristics associated with vaginal hysterectomy from 2004 to 2008. Results. There was an overall increase in the use of vaginal hysterectomies from 12 to 34%, a decrease in the use of abdominal hysterectomies and a consistent number of laparoscopic hysterectomies. The number of vaginal hysterectomies varied between regions, ranging from 2 to 86%. The use of vaginal hysterectomy was not dependent on the total number of hysterectomies performed at the hospital. The characteristics associated with vaginal hysterectomy were higher age, smaller uterus size, indications for surgery (genital prolapse and severe uterine bleeding), less smoking and moderate alcohol intake. Conclusions: Vaginal hysterectomy has replaced abdominal hysterectomy increasingly but cannot be directly correlated to the implementation of national guidelines as there was large national variation. Several characteristics are significantly associated with vaginal hysterectomy.

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

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.

Total versus subtotal hysterectomy: an observational study with one-year follow-up.

The aim of this study was to compare total and subtotal abdominal hysterectomy for benign indications, with regard to urinary incontinence, postoperative complications, quality of life (SF‐36), constipation, prolapse, satisfaction with sexual life, and pelvic pain at 1‐year postoperative. Eighty women chose total and 105 women chose subtotal abdominal hysterectomy. No significant differences were found between the 2 operation methods in any of the outcome measures at 12 months. Fourteen women (15%) from the subtotal abdominal hysterectomy group experienced vaginal bleeding and three women had their cervix removed.

Objective comparison of subtotal vs. total abdominal hysterectomy regarding pelvic organ prolapse and urinary incontinence: a randomized controlled trial with 14-year follow-up

OBJECTIVE To compare subtotal and total abdominal hysterectomy regarding objective assessment of pelvic organ prolapse, urinary incontinence and voiding function 14 years after hysterectomy for benign diseases. STUDY DESIGN Long-term follow-up of a randomized clinical trial of subtotal vs. total abdominal hysterectomy with objective outcomes. All randomized women still alive and living in Denmark (n=304) were invited to answer a questionnaire and come for clinical examination consisting of 20-min pad weighing test, urinary flow, measurement of residual urine, POP-Q measurement for pelvic organ prolapse, 3 day voiding diary and also filled out the pelvic floor distress inventory (PFDI-20) questionnaire. RESULTS We included 100/304 (32.9%) women (subtotal hysterectomy: 53, total hysterectomy: 47) in the clinical examinations. The study questionnaire was answered by 197 (64.8%) (subtotal: 97, total: 100), the PFDI-20 questionnaire was answered by 140 (46.1%) (subtotal: 68, total: 72). We found no difference between subtotal and total abdominal hysterectomy in the PFDI-20 scores or regarding objectively assessed urinary incontinence or pelvic organ prolapse. In the subtotal hysterectomy group, 31 (59.6%) women had objective stage 2 pelvic organ prolapse compared with 33 (70.2%) in the total hysterectomy group (P=0.27); however, only 6/31 and 9/33 had symptoms (P=0.45). There were more anterior pelvic organ prolapses in the total hysterectomy group (N=10) than in the subtotal hysterectomy group (N=4) (P=0.048). We found a higher mean maximum flow rate (Qmax) in the subtotal hysterectomy group (34.78ml/s) than in the total hysterectomy group (27.08ml/s) (P=0.042) as well as a higher mean functional capacity in the subtotal hysterectomy group (526ml) than in the total hysterectomy group (443ml) (P=0.0147) according to the voiding diary. CONCLUSION Subtotal and total abdominal hysterectomy are comparable regarding long-term objective pelvic organ prolapse and urinary incontinence. The subtotal hysterectomy group had a higher Qmax and voided volume.

Clinical risk factors and urodynamic predictors prior to surgical treatment for stress urinary incontinence: a narrative review

Introduction and hypothesisKnowledge about clinical risk factors and the value of urodynamic testing is important to optimize treatment strategy and secure true informed consent.MethodsWe reviewed the relevant literature to clarify the evidence regarding clinical risk factors and the predictive value of urodynamic testing in patients with urinary incontinence, where surgery is considered. Because of the paucity of evidence based on randomized controlled trials, we conducted a narrative review of the published literature.ResultsClinical risk factors in terms of mixed urinary incontinence, previous incontinence surgery, body mass index (BMI) ≥ 35, age ≥ 75, and presence of diabetes mellitus were significantly related to decreased outcome of incontinence surgery. Furthermore, noninvasive and invasive urodynamic parameters indicating detrusor overactivity, voiding difficulties, low urethral pressure, and bladder-neck immobility were related to poorer outcome of surgery.ConclusionsThis study summarized the available evidence regarding preoperative clinical risk factors and urodynamic parameters indicating decreased or adverse outcome of surgery, and this report also provides clinical recommendations.

Systematic review of the limited evidence for different surgical techniques at benign hysterectomy: A clinical guideline initiated by the Danish Health Authority

Hysterectomy for benign gynecological conditions is a common operation that has developed extensively through the last 20 years. Methods and surgical techniques vary throughout the regions in Denmark as well as internationally. Consequently, the Danish Health Authority initiated a national clinical guideline on the subject based on a systematic review of the literature. A guideline panel of seven gynecologists formulated the clinical questions for the guideline. A search specialist performed the comprehensive literature search. The guideline panel reviewed the literature and rated the quality of evidence according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Finally, the panel weighted the evidence and formulated the clinical recommendations. Based on the limited available literature and the corresponding quality of evidence according to GRADE, the guideline panel gave the following recommendations: ↓ Subtotal hysterectomy should only be preferred over total hysterectomy after careful consideration because there are documented disadvantages such as persistent cyclic vaginal bleeding (⊕ΟΟΟ). ↑ Consider vaginal hysterectomy rather than conventional laparoscopic hysterectomy for non-prolapsed uteri when feasible (⊕ΟΟΟ). ↓ Robot-assisted laparoscopic hysterectomy should only be preferred over conventional laparoscopic hysterectomy after careful consideration because the beneficial effect is uncertain and because of the longer operating time (⊕⊕ΟΟ). ↑ Consider concomitant bilateral salpingectomy at the time of hysterectomy if the procedure is not considered to increase the risk of complications significantly (⊕ΟΟΟ). ↑ Consider vaginal vault suspension to the cardinal and the uterosacral ligaments when performing hysterectomy for non-prolapsed uteri (⊕ΟΟΟ). Though supporting evidence is missing, the guideline panel emphasizes that it is good practice not to morcellate uteri with presumed fibroids inside the peritoneal cavity (√). The recommendations serve as professional advice in specific clinical situations. The implementation of the guideline in Denmark will be monitored through the national Danish Hysterectomy and Hysteroscopy Database.