Ann Tabor

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.u2002 The effect of hysterectomy on sexuality is not fully elucidated and until recently total and subtotal hysterectomies have only been compared in observational studies.

Hysterectomy on benign indication in Denmark 1988–1998

Background. The aims of the study were to describe the trends in Danish hysterectomy rates from 1988 to 1998 for operations done on benign indication.

Management of ovarian cysts

Background.u2002 The treatment of an ovarian cyst relies on its nature, and accurate preoperative discrimination of benign and malignant cysts is therefore of crucial importance. This study was undertaken to review the literature concerning the preoperative diagnosis and treatment of ovarian cysts.

Twin pregnancy: the role of ultrasound in management

Determination of chorionicity is one of the most important issues in the management of twin pregnancy.

Lower urinary tract symptoms after total and subtotal hysterectomy: results of a randomized controlled trial.

The aim of this Danish multicenter trial was to compare the proportion of women with lower urinary tract symptoms after total abdominal hysterectomy (TAH) and subtotal abdominal hysterectomy (SAH) for benign uterine disorders. A total of 319 women were randomized to TAH (n=158) or SAH (n=161). Women were followed up for 1xa0year by strict data collection procedures, including postal questionnaires. Results were analyzed by intention-to-treat analyses. Urinary incontinence was found less often among TAH women than among SAH women. This was due to a larger reduction of the number of women with stress and urinary incontinence in the TAH group. No other differences were found between the two operation methods. The number of women with urinary incontinence and frequency was reduced from study entry for follow-up, while double/triple voiding was increased. Incontinent women had significantly lower quality of life scores than continent women.

Danish gynecologists' opinion about hysterectomy on benign indication: results of a survey

Aims.u2003 To survey Danish gynecologists recommendations concerning hysterectomy and its method for benign diseases.

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.

Randomized clinical trial of total vs. subtotal hysterectomy: validity of the trial questionnaire

Background.u2003 To ensure the internal validity of a trial it is recommended to undertake a validation study of the method measuring the outcome.

Randomised controlled trial of total versus subtotal hysterectomy with one‐year follow up results

Sir, We were delighted to see another randomised controlled trial comparing total and subtotal hysterectomy published in volume 110. However, as Gimbel et al. point out, the results of their trial differed from our own. We found no difference in urinary function (both objective and subjective measures), while they found that total hysterectomy resulted in less urinary incontinence (subjective measure) at one year. Gimbel et al. suggest that the variation between our results could be due to methodological differences, but they raise a number of inaccurate points about our trial. These may have misinformed your readers and should therefore be corrected. Firstly, in their introduction, Gimbel et al. refer to our study and a study by Lalos and Bjerle and dismiss both studies’ conclusions as ‘questionable’ because of their ‘small size’. The study by Lalos et al. was indeed small (total number 22) but our study had 279 women, which is equivalent to the 277 included in Gimbel et al.’s final analysis. The power calculation of our study was based on a previous randomised, controlled study. A larger sample size would not have clarified the issue any further. Secondly, Gimbel et al. state that 35% of our study population were Afro-Caribbean and refer to a publication suggesting that this group have a lower incidence of stress incontinence than Caucasian women. In fact, 27% in the subtotal hysterectomy group and 24% in the total hysterectomy group were Afro-Caribbean. We would argue that the ethnic diversity of our study population renders our results more relevant to the international community. Thirdly, Gimbel et al. question our measurement of urinary function. We assessed urinary function both subjectively (by questionnaire) and objectively (by urodynamic studies) and found that neither operation adversely affected urinary function. While it is indeed the case that subjective and objective assessments of urinary incontinence do not always give the same result, our trial did in fact give the same result. We therefore fail to understand Gimbel et al.’s statement that our trial ‘confirmed this paradox’. We not only found a statistically significant subjective reduction in urinary incontinence in both groups, we were also able to confirm this objectively. In addition, our questionnaire measured both urge and stress incontinence, because there is evidence that urgency and bothersome urge incontinence are more common after hysterectomy than stress incontinence. In contrast, Gimbel et al. defined urinary incontinence as a subjective complaint from which the woman suffered ‘always’ or ‘often’ (1⁄4incontinent) or ‘rarely’ or ‘never’ (1⁄4continent) and did not differentiate between urge and stress incontinence. This makes it hard to interpret their results. Finally, perhaps in seeking to justify why their trial was not blinded, Gimbel et al. criticise our use of the sealed opaque envelope technique for randomisation. Our envelopes were sealed by a colleague who was not otherwise involved in the study and the envelopes were opened in theatre, after the abdominal incision had been made. The principal investigator and the patients remained blinded to the allocation for 12 months. Thus, while concealment of allocation by the sealed opaque envelope technique can indeed be broken, it was highly unlikely in our study and certainly could not explain the differences in the findings between our two trials. In conclusion, the variations in findings between these two studies of similar sample size are most likely due to methodological differences. Our study was blinded while Gimbel et al.’s was not. Our assessment of urinary function was more exhaustive and robust. The execution of our study was arguably more rigorous, since we assessed pelvic organ function at three time points (pre-operation, 6 months post-operation and at 12 months post-operation). The trends in our findings remained consistent, adding to the internal validity of our study. Gimbel et al., on the other hand, assessed their patients only twice, pre-operatively and at 12 months. The possibility of type 1 error in their findings cannot be readily dismissed.