Uterine artery embolisation versus hysterectomy for leiomyomas: primary and 2-year follow-up results of a randomised prospective clinical trial. Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results. Uterine artery embolization versus myomectomy: impact on quality of life--results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) Trial. Pain and return to daily activities after uterine artery embolization and hysterectomy in the treatment of symptomatic uterine fibroids: results from the randomized EMMY trial. Uterine fibroids: uterine artery embolization versus abdominal hysterectomy for treatment--a prospective, randomized, and controlled clinical trial. A randomised comparison and economic evaluation of laparoscopic-assisted hysterectomy and abdominal hysterectomy. The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. Quality of life and surgical outcome after total laparoscopic hysterectomy versus total abdominal hysterectomy for benign disease: a randomized, controlled trial. Endometrial resection versus vaginal hysterectomy for menorrhagia: long-term clinical and quality-of-life outcomes.
To compare uterine artery embolisation (UAE) and hysterectomy for the treatment of leiomyomas at 2-year follow-up in a prospective, randomised, single-centre study.
                Fifty-seven symptomatic patients were randomised to UAE (n = 27) or hysterectomy (n = 30). Complications, recovery, reinterventions and satisfaction with treatment were recorded. Primary endpoint was improvement of symptoms. Analyses were performed by intent-to-treat and per protocol.
                Two hysterectomy patients (7%) developed major complications. Hospital discharge occurred earlier after UAE than after hysterectomy (p < 0.001). Length of sick leave was longer after hysterectomy than after UAE (p < 0.001). Twenty-two (82%) UAE patients and 28 (93%) hysterectomy patients reported overall relief of symptoms (p = 0.173). In 12/18 (67%) UAE patients menorrhagia was completely resolved or reduced. Improvement of pressure symptoms was reported significantly more by UAE patients than by hysterectomy patients (19/20 [95%] versus 18/26 [69%], respectively; p = 0.029). Five (19%) UAE patients underwent additional interventions due to worsening symptoms. Twenty-four (89%) UAE patients and 29 (97%) hysterectomy patients would have chosen treatment again (p = 0.336).
                UAE gave relief of symptoms (apart from menorrhagia) comparable to hysterectomy with less severe complications, but with an increased rate of secondary interventions. UAE may be the preferable treatment especially for patients with pressure symptoms. To compare the long-term results of uterine artery embolisation (UAE) with surgery for women with symptomatic uterine fibroids.
                Pragmatic, open, multicentre, randomised trial.
                Twenty-seven participating UK secondary care centres.
                Women aged ≥18 years with symptomatic fibroids who were considered to justify surgical treatment.
                In total, 157 women were randomised (in a 2:1 ratio): 106 to UAE and 51 to surgery (hysterectomy 42; myomectomy nine).
                Quality of life at 5 years, as assessed by the Short Form General Health Survey (SF-36). Secondary measures included complications, adverse events and the need for further intervention.
                There were no significant differences between groups in any of the eight components of the SF-36 scores at 5 years (minimum P = 0.45). Symptom score reduction and patient satisfaction with either treatment was very high, with no group difference. Rates of adverse events were similar in both groups (19% embolization and 25% surgery; P = 0.40). The 5-year intervention rate for treatment failure or complications was 32% (UAE arm) and 4% (surgery arm), respectively. The initial cost benefit of UAE over surgery at 12 months was substantially reduced because of subsequent interventions, with treatments being cost neutral at 5 years.
                We have found that UAE is a satisfactory alternative to surgery for fibroids. The less invasive nature of UAE needs to be balanced against the need for re-intervention in almost a third of patients. The choice should lie with the informed patient.
                © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG. This study was designed to compare quality of life (QoL) outcomes after uterine artery embolization (UAE) or myomectomy.
                Women with symptomatic fibroids diagnosed by ultrasound who wished to preserve their uterus were randomized to myomectomy (n=81) or UAE (n=82). Endpoints at 1 year were QoL measured by a validated questionnaire, hospital stay, rates of complications, and need for reintervention.
                UAE patients had shorter hospitalization (2 vs. 6 days, p<0.001). By 1 year postintervention, significant and equal improvements in QoL scores had occurred in both groups (myomectomy n=59; UAE n=61). There had been two (2.9%) major complications among UAE versus 6 (8%) among myomectomy patients (not significant). By 2 years, among UAE patients (n=57) there were eight (14.0%) reinterventions for inadequate symptom control compared with one (2.7%) among myomectomy patients (n=37). Half of the women who required hysterectomy had concomitant adenomyosis missed by US.
                UAE and myomectomy both result in significant and equal improvements in QoL. UAE allows a shorter hospital stay and fewer major complications but with a higher rate of reintervention. To evaluate the safety and efficacy of uterine artery embolization (UAE) and hysterectomy for symptomatic uterine fibroids by means of a randomized controlled trial. The present paper analyses short-term outcomes, i.e., pain and return to daily activities.
                Patients were randomized (1:1) to UAE or hysterectomy. Pain was assessed during admission and after discharge, both quantitatively and qualitatively, using a numerical rating scale and questionnaires. Time to return to daily activities was assessed by questionnaire.
                Seventy-five patients underwent hysterectomy and 81 patients underwent UAE. UAE patients experienced significantly less pain during the first 24 hr after treatment (p = 0.012). Non-white patients had significantly higher pain scores. UAE patients returned significantly sooner to daily activities than hysterectomy patients (for paid work: 28.1 versus 63.4 days; p < 0.001). In conclusion, pain appears to be less after UAE during hospital stay. Return to several daily activities was in favor of UAE in comparison with hysterectomy. To evaluate the effectiveness of uterine artery embolization (UAE) in the management of bleeding in patients with uterine fibroids and to compare UAE with hysterectomy, particularly with regard to length of hospital stay and associated complications (ie, safety).
                A prospective clinical trial was performed with patients who were randomly assigned to one of two groups: patients who were offered the option of undergoing either UAE or hysterectomy (group 1) and patients who were not informed of the alternative treatment-that is, UAE (group 2). The primary variables that were considered for evaluation of the effectiveness, efficiency, and safety of the two procedures were, respectively, bleeding cessation, total length of hospital stay, and resulting complications. The lengths of hospital stay in the two study arms were compared on an intent-to-treat basis. Owing to crossover between the treatment arms, however, effectiveness and safety were evaluated on the basis of the actual treatment received.
                The clinical success rate for the patients who underwent UAE, which was based on the cessation of bleeding, was 86% (31 of 36 patients). The mean hospital stay for group 1 was 4.14 days shorter than that for group 2 (P <.001). Ten (25%) of the 40 patients who underwent UAE experienced minor complications, in contrast to four (20%) of the 20 who underwent hysterectomy and experienced major complications.
                Compared with hysterectomy, UAE is safe and effective for treatment of bleeding fibroids, necessitates a shorter hospital stay, and results in fewer major complications. To determine the safety, cost effectiveness and effect on quality of life of laparoscopic-assisted vaginal hysterectomy (LAVH) compared with total abdominal hysterectomy (TAH) in the management of benign gynaecological disease.
                Randomised controlled trial and economic evaluation.
                Three hospitals in the West of Scotland.
                Two hundred women scheduled for an abdominal hysterectomy for benign gynaecological disease.
                Conversion rate of LAVH to TAH, complication rates, NHS resource use and costs, quality of life using EuroQol 5 D visual analogue scale, and achievement of milestones.
                The overall incidence of operative complications was 14% in the TAH group and 8% in the LAVH group, with an 8% conversion rate. Length of operation was significantly greater in the women having LAVH at 81 +/- 30 min vs 47 +/- 16 min (P < 0.001). There was no difference in analgesic requirements between the groups although there was a significantly shorter hospital stay for those having LAVH. The rate of post-surgery recovery, satisfaction with operation and quality of life at four weeks post-operative were similar in the two groups of women. LAVH was significantly more expensive than TAH and remained more expensive for all but the most extreme scenario.
                This study demonstrates that despite the decreased length of hospital stay, LAVH is more expensive than TAH. In addition, recovery following operation and patient satisfaction were not affected by the route chosen. It is unlikely that LAVH represents an efficient use of NHS resources. To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial.
                Two parallel, multicentre, randomised trials.
                28 UK centres and two South African centres.
                1380 women were recruited; 1346 had surgery; 937 were followed up at one year. Primary outcome Rate of major complications.
                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.
                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. Minimally invasive surgery aims to achieve at least a similar clinical effectiveness with a quicker recovery than traditional open techniques. Although there have been numerous randomized clinical trials comparing laparoscopic hysterectomy with hysterectomy by laparotomy, only a few studies have compared quality of life after different types of hysterectomy. None of these studies evaluated total laparoscopic hysterectomy. In this paper, we report on a randomized comparison of quality of life after total laparoscopic versus total abdominal hysterectomy.
                Randomized, controlled trial (Canadian Task Force classification I).
                Single-center teaching hospital in The Netherlands.
                Patients scheduled for hysterectomy for a benign condition, in whom a vaginal hysterectomy was not possible and laparoscopic hysterectomy was feasible (mobile uterus not exceeding the size of 18 weeks' gestation).
                Abdominal versus laparoscopic hysterectomy.
                Patients completed the Dutch version RAND-36 health survey preoperatively as well as at 5 time points in the first 12 weeks after surgery. The primary outcome of the study was quality of life as measured by the RAND-36. A linear mixed model was used for statistical analysis while accounting for baseline values. Secondary outcomes were hospital stay and complications. There were 88 patients eligible, of whom 59 gave consent for randomization. Twenty-seven women were allocated to the laparoscopic arm and 32 to the abdominal arm. We found a significant treatment effect favoring laparoscopic hysterectomy in the RAND-36 scale for vitality. Laparoscopic hysterectomy performed better on all other scales of the RAND-36, but these differences were not statistically significant.
                Laparoscopic hysterectomy results in more postoperative vitality when compared with abdominal hysterectomy. For this reason, all women with a benign condition requiring abdominal hysterectomy, in whom the laparoscopic approach is feasible, should have the chance to choose laparoscopic hysterectomy. Our purpose was to compare patients' satisfaction with the effect of treatment, health-related quality of life, psychologic status, and sexual functioning 2 years after endometrial resection or vaginal hysterectomy for menorrhagia.
                Menorrhagic women < or = 50 years old with a mobile uterus smaller than a 12-week pregnancy were enrolled in a randomized trial to compare endometrial resection and vaginal hysterectomy. Two years after surgery the women were requested to rate the degree of satisfaction with the effect of the operation and to complete the Short Form 36 general health survey questionnaire, the Hospital Anxiety and Depression Scale, and the revised Sabbatsberg Sexual Rating Scale.
                Forty-one subjects underwent endometrial resection and 44 underwent vaginal hysterectomy without major complications. Of the 77 women attending the 2-year follow-up visit, 33 of 38 (86.8%) in the endometrial resection arm were very satisfied or satisfied with the treatment compared with 37 of 39 (94.8%) of those in the hysterectomy arm. According to the Short Form 36 questionnaire, social functioning and vitality scores were significantly better in the hysterectomy group than in the resection group. Significantly lower Hospital Anxiety and Depression Scale anxiety scores were observed in the former than in the latter subjects. The Sabbatsberg Sexual Rating Scale scores were similar in the two groups.
                In patients requiring surgical treatment for menorrhagia vaginal hysterectomy appeared slightly more satisfying and offered a better health-related quality of life than did endometrial resection at 2-year follow-up. Hysterectomy did not adversely affect psychologic status and sexual functioning.
UAE appears to have an overall patient satisfaction rate similar to hysterectomy and myomectomy, while offering an advantage with regards to a shorter hospital stay and a quicker return to routine activities. However, UAE is associated with a higher rate of minor complications and an increased likelihood of requiring surgical intervention within two to five years of the initial procedure. There is very low level evidence suggesting that myomectomy may be associated with better fertility outcomes than UAE, but more research is needed.