Graham Phillips

The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy

Objective To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial. Design Two parallel, multicentre, randomised trials. Setting 28 UK centres and two South African centres. Participants 1380 women were recruited; 1346 had surgery; 937 were followed up at one year. Primary outcome Rate of major complications. Results In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference 4.9%, 95% confidence interval 0.9% to 9.1%) and the number needed to treat to harm was 20. Laparoscopic hysterectomy also took longer to perform (84 minutes v 50 minutes) but was less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and resulted in a shorter stay in hospital after the operation (3 days v 4 days). Six weeks after the operation, laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy (SF-12, body image scale, and sexual activity questionnaires). In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference 0.3%, -5.2% to 5.8%), and the number needed to treat to harm was 333. We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform (72 minutes v 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4% v 4.8%, P = < 0.01). However, this trial was underpowered. Conclusions Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. It also took longer to perform but was associated with less pain, quicker recovery, and better short term quality of life. The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications; however, vaginal hysterectomy took less time.

Six hundred endometrial laser ablations

Objective To report the effectiveness and safety of endometrial laser ablation in the treatment of menorrhagia, as determined by detailed follow-up of 600 operations for at least 6 months. Methods Operative data from 600 endometrial laser ablations performed on 524 women were collected. Five hundred one (96%) of these women were followed with consultations and questionnaires. The mean duration of follow-up was 15 months (range 6–42). Results No major operative morbidity occurred. There were no cases of primary or secondary hemorrhage, uterine perforations with the operating instrument, or immediate laparotomy. A successful outcome was reported by 83.4% of patients. A second endometrial laser ablation was required in 14.3% of the women. success increased with increasing age and low fluid absorption. Cavity length, operation time, duration of follow-up, and whether it was a first or second procedure were not associated with any difference in the success rate, although the hysterectomy rate tended to rise with increasing length of follow-up. Conclusion This study, the largest one published from a single institution, with a mean follow-up duration of 15 months, confirms that endometrial laser ablation is a safe and effective treatment for dysfunctional uterine bleeding.

Risk of hysterectomy after 1000 consecutive endometrial laser ablations

Objectives To determine the hysterectomy rate after endometrial laser ablation, allowing for variable follow up times, and to evaluate the factors that might predict outcome.

A randomised controlled trial comparing the Cavaterm endometrial ablation system with the Nd:YAG laser for the treatment of dysfunctional uterine bleeding

Objective To compare the effectiveness of the Cavaterm thermal balloon endometrial ablation system with the Nd:YAG laser for the treatment of dysfunctional uterine bleeding.

Laparoscopic-assisted Doderlein hysterectomy: retrospective analysis of 300 consecutive cases

Objective To assess the clinical outcomes of the Doderlein laparoscopic‐assisted hysterectomy.

A prospective study to evaluate oophorectomy at the time of vaginal hysterectomy

Sir, We have read with interest the recent papers from Adam Magos’s unit regarding aspects of vaginal hysterectomy (Vol 103, March 1996l and Vol 103, September 1996*). This team should be congratulated on pointing out what many well trained vaginal surgeons have recognised for a long time, that neither the size of the uterus nor the requirement to remove ovaries need be contraindications to performing vaginal hysterectomy. From this study on fibroids’ the authors conclude “that considerable uterine enlargement should not be looked upon as a contraindication to vaginal hysterectomy and should certainly not be used to justify the use of the abdominal or laparoscopic route” and from the study on removal of the ovaries* they conclude “that the only indication for a laparoscopic approach to oophorectomy should be when there is an adnexal mass”. We believe that these conclusions are not substantiated by their observations and need to be challenged. Our first concern is admittedly a philosophical one. Is it appropriate in 1996 to subject a premenopausal woman to a major surgical procedure such as hysterectomy without precisely defining any pathology which may be present and attempting to remove that pathology as completely as possible? In women presenting with heavy painful periods, endometriosis is frequently the underlying cause of the symptoms. In the 88 women in their oophorectomy study not one was reportedly performed for the indication of endometriosis (although 2/40 in whom oophorectomy was performed were subsequently shown to have endometriosis on histological examination). Women with uterine fixity were excluded from the study but much significant endometriosis does not result in a fixed uterus. A classical vaginal hysterectomy does not permit visualisation of the extent of any endometriosis, adhesions or the cause or extent of ovarian fixity. It is possible that cases of endometriosis were missed because the pelvis was not adequately visualised. Just as hysteroscopy has replaced ‘blind’ D and C, we would suggest that operative laparoscopic inspection should replace ‘blind’ vaginal hysterectomy. If the advantage is conceded of inserting the laparoscope at the beginning of the procedure in order to define accurately any pathology, surely it will also be conceded that subsequent excision of extrauterine pelvic pathology, mobilisation of the uterine tubes and ovaries and securing the infundibulo-pelvic ligaments are performed much more simply and with less trauma under direct laparoscopic visualisation than by blind vaginal hysterectomy. This fact is partially conceded by the writers’ need to resort to what they quaintly call transvaginal endoscopic oophorectomy (TVEO). With this technique they insert a laparoscope through the vagina and use laparoscopic instruments to facilitate removal of the ovaries. This technique is far removed from the vaginal hysterectomy described by Heaney and appears to be simply a rather inefficient way of performing a laparoscopic assisted procedure. In our experience haematuria is a very rare complication of abdominal or laparoscopic assisted vaginal hysterectomy. These studies imply that large uteri and ovaries can be removed vaginally without difficulty or force. The presence ofhaematuria in 14 out of 88 (16%) women in the ovarian study and 6 out of 14 (43%) cases in the fibroid study suggest otherwise, as does the finding of vaginal grazing in 5 out of 14 women. The delivery of such uteri closely resembles the conduct of difficult vaginal childbirth. In obstetrics it is accepted that just because a vaginal delivery is technically possible it is not always the most appropriate route. We would suggest that the same is true for hysterectomy. We have for some time been concerned with the force required to deliver bulky uteri by the vaginal route. To overcome this problem we have been developing laparoscopic techniques based on the work of Kader and Semm in which all the major uterine vessels are secured laparoscopically and then the bulk of the uterus is reduced by one of a number of forms of laparoscopic morcellation prior to vaginal extraction. This approach appears to permit the fairly atraumatic delivery of large uteri without the need for laparotomy. Surely an approach aimed at surgical gentleness, even in the presence of large masses, is to be preferred to a technique which produces a 43% haematuria rate. The place of the various laparoscopically-assisted vaginal hysterectomies compared with vaginal hysterectomy is not yet established. We would again invite all gynaecologists with an open mind and surgical skills in both laparoscopic and vaginal hysterectomy to participate in the EVALUATE randomised trial of abdominal, laparoscopic and vaginal hysterectomy. Please contact us if you are interested in participating in this multi-centre study.

Reducing hospital stay after abdominal hysterectomy

Sir, Having at one time been taunted as a senior registrar with the cliche, ‘why make an easy abdominal hysterectomy a difficult vaginal one’, I was pleased to read Mr Magos’s paper on vaginal hysterectomy for the large uterus (Vol 103, March 1996)’ which clearly demonstrates that some enlarged uteri, even as big as 1 kg, can be removed vaginally without resorting to abdominal or laparoscopic hysterectomy. However, I should like to see a more detailed breakdown of these uteri by weight (e.g. how many were < 500 g, 500-750 g and > 750 g) and know the time span over which these cases were collected, whether they were selected or unselected, what the total number of hysterectomies performed over the same period was, and how many were abdominal. For what reason was the second patient who stayed for more than four days kept in hospital? I freely admit that precisely what the laparoscope contributes to a hysterectomy that permits uteri weighing between one and two kilograms to be removed without a laparotomy and with minimal morbidity remains to be articulated. Nonetheless, since January 1, 1996, I removed all three uteri I saw weighing > 1 kg (1200 g, 1525 g and 1800 g) laparovaginally with minimal blood loss, and all three women went home the day after surgery without analgesia (as did two others with uteri weighing 500 g and 575 g). Mr Magos has come commendably close with his uterus of 1100 g, but I doubt that he will ever equal vaginally what can be accomplished laparovaginally, even if I cannot yet say for certain why.