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ORIGINAL RESEARCH |
From the Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, Scotland.
Address reprint requests to: Christine Bain, MRCOG, MFFP, Aberdeen Royal Infirmary, Wards 42/43, Foresterhill, Aberdeen, Grampian AB25 2ZN, Scotland; E-mail: bainhouse{at}supanet.com.
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ABSTRACT |
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 ABSTRACT MATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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METHODS: Women were randomized to either endometrial ablative method. Menstrual status, satisfaction, acceptability, and changes in health-related quality of life were obtained by a self-completed questionnaire. Case note review and personal communication identified further surgery rates at 2 years after each procedure.
RESULTS: Among the original 263 women who underwent endometrial ablation, 249 (95%) returned questionnaires at 2 years. Menstrual status in both groups was similar, although the amenorrhea rate was higher after microwave endometrial ablation. Seventy-nine percent of women were either completely or generally satisfied after microwave ablation compared with 67% after transcervical endometrial resection. Health-related quality-of-life scores remained higher than at recruitment for both treatments. Hysterectomy rates were similar at 2 years (11.6% after microwave endometrial ablation and 12.7% after transcervical endometrial resection), and no repeat endometrial ablative procedures were required.
CONCLUSION: Microwave endometrial ablation is an effective alternative to transcervical endometrial resection for dysfunctional uterine bleeding.
Endometrial ablative methods, such as transcervical endometrial resection, are now established methods for the treatment of heavy menstrual loss and have been compared with hysterectomy.1–7 These methods require substantial training and experience to be performed effectively and safely. New endometrial ablative techniques, such as microwave endometrial ablation, are faster and easier to perform.8,9 Few of these new techniques have undergone follow-up evaluation within the context of a randomized controlled trial.10 This prospective randomized controlled trial was performed to evaluate the menstrual effect and surgical intervention rate after microwave endometrial ablation in unselected women. The overall satisfaction and changes in health-related quality of life at 2 years have also been assessed.
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MATERIALS AND METHODS |
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The treatment allocation was by telephone. A secretary opened the next in line of a series of sealed opaque, sequentially numbered envelopes, which contained the treatment code, determined by computer-generated random number tables. A baseline clinical questionnaire6,9,11 and a generic health-related quality-of-life questionnaire (Short Form 3612–14) were all completed at recruitment. The clinical questionnaire included specific questioning using a five-point scale on the severity of pain and bleeding for each day of their period. This scale provided total pain and bleeding scores for each participant to a maximum of 50 for each symptom.6,9,11 Questions pertaining to bowel and bladder symptoms were also included to establish any effect from the microwave endometrial ablation. Preoperative endometrial preparation took place 5 weeks before the operation in the form of subcutaneous goserelin 3.6 mg as is standard practice.15,16 Before the study, the two surgeons had each performed a minimum of 50 transcervical endometrial resections and performed five microwave endometrial ablations after attending a training session. Eleven transcervical endometrial resection procedures were performed by other surgeons.
Both allocated procedures were performed under general anesthesia with antibiotic cover. Transcervical endometrial resection was performed with a combined electrocautery technique using a rollerball at the fundus and cornual areas and a 90° loop for the walls with 1.5% of glycine as the distending fluid. The energy used for both modalities was between 80–120 W. Women undergoing microwave endometrial ablation had a pelvic ultrasound scan immediately before treatment to identify endometrial thickness and any intramural fibroids. After cervical dilatation to 9 mm, any inadvertent false passage or uterine perforation was excluded by gas hysteroscopy before the insertion of the microwave applicator into the uterine cavity. The presence of submucosal fibroids was also recorded. Once the microwave applicator reached the uterine fundus and the previously recorded cavity length was confirmed by demarcations on the applicator, the procedure began. The applicator was gently moved in the coronal plane from each cornual area to the internal os as if painting the uterine cavity with microwave energy. The speed of applicator movement was dependent on visual information from a computer screen identifying a treatment temperature band. The microwave power was controlled by the surgeon using a foot pedal, but safety mechanisms prevented significant increases above the treatment band within the microwave system. A colored band on the applicator prompted the surgeon to stop treatment when seen at the external cervical os. Concomitant rectal analgesia was given using 100 mg of diclofenac (a nonsteroidal anti-inflammatory drug). If this was contraindicated, 500 mg of paracetamol was administered at the end of the procedure.
Hospital review took place at 4 months and follow-up by mail at 12 and 24 months. Each original participant received a questionnaire 2 years after treatment. The clinical component of the questionnaire identified menstrual status and other gynecologic symptoms. Satisfaction and acceptability6,9,11 of menstrual improvement were obtained by direct questioning. The quality-of-life questionnaire (Short Form 36)12–14 was completed to identify changes in health-related quality of life between the two groups. Subsequent surgical intervention for any participant was determined by the hospital database as Aberdeen Royal Infirmary is the only hospital with a gynecologic service for the patient catchment area.
The original calculation required a minimum sample size of 230 subjects providing an 80% power to detect a 15% absolute difference in treatment satisfaction at a 5% significance level (P < .05). All data were entered onto a database using SPSS for Windows, 8.00 (SPSS, Chicago, IL), and analyses were by intention to treat, using this program. Continuous variables with a normal distribution were analyzed using independent and paired t tests. The Mann-Whitney U test was used for ordinal or nonparametric continuous variables. Independent nominal data were analyzed using 
2 or Fisher exact test. Paired categoric data, which were related or consisted of dichotomous variables, were analyzed with Wilcoxon signed rank test and McNemar test, respectively.
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RESULTS |
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At the time of recruitment, age and menstrual characteristics were comparable in both groups (Table 1
). Using the five-point scaling system within the questionnaire, the mean bleeding score was around 28 for each group, but ranged from 10 to 50 within the trial population. All eight health-related quality-of-life dimensions identified by Short Form 36 scores were lower than for women of the same age in the general population17 in both groups before the allocated endometrial ablation.
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Menstrual symptoms at 2 years are summarized in Table 2. Both treatment groups continue to show highly significant reductions in bleeding and pain scores (P < .001). Both median bleeding scores and amenorrhea rates (47% after microwave endometrial ablation and 41% after transcervical endometrial resection) were not significantly different between the two treatments.
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Surgical intervention rates were similar during the 2-year follow-up after both treatments. In the microwave endometrial ablation cohort, six (5%) had a hysterectomy and five (4%) allocated to transcervical endometrial resection. This was a hysterectomy rate of 11.6% after microwave endometrial ablation and 12.7% after transcervical endometrial resection at 2 years. Four combined laparoscopy and hysteroscopy procedures were performed in the second year, two women in each treatment group. Two women underwent diagnostic hysteroscopy, one in each group, and no repeat ablative procedures were performed in either group. There was one pregnancy resulting in a termination at 9 weeks’ gestation in the microwave endometrial ablation group 17 months after the procedure. This woman was experiencing amenorrhea at the time of conception, not using contraception despite advice, and alerted to pregnancy by recurrent vomiting and confirmed by urinary hCG testing.
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DISCUSSION |
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The high incidence of preoperative urinary symptoms in this study has been previously observed in women with heavy menstrual loss,19–22 but we have no explanation for the improved urinary symptoms found at 2 years. This has not previously been reported, and caution is required in their interpretation as urinary symptoms were not a primary outcome measurement. Bowel symptoms, as expected, do not appear to be different from baseline. Both these findings are reassuring that no medium term effects are found to affect the bladder or bowel after microwave endometrial ablation.
The low rate of treatment failures and hysterectomy in both groups agree with previous reports.8,23,24 After hysteroscopic ablative procedures and microwave endometrial ablation in selected women, failure rates plateau over time.23 However, a small number of women after both treatment methods required diagnostic laparoscopy because of pelvic pain. Full information on the laparoscopic pelvic findings for this small subgroup of women has not been evaluated to date. Endometrial ablation does not provide contraception even in the absence of menstruation, and its effect on future pregnancy is poorly understood. Women should be counseled accordingly, and a permanent contraceptive method should be offered at endometrial ablation.25 One woman in this study who elected against medical advice not to continue contraception or to undergo sterilization at endometrial ablation became pregnant. She was amenorrheic at the time of conception, and her only symptom was hyperemesis gravidarum. This woman elected to have a termination; if she had considered continuing with the pregnancy, no definitive prognosis could be given, though term pregnancies have occurred after other endometrial ablative methods.26
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Footnotes |
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Received April 5, 2001. Received in revised form October 25, 2001. Accepted November 1, 2001.
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REFERENCES |
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2. Sculpher MJ, Bryan S, Dwyer N, Hutton J, Stirrat GM. An economic evaluation of transcervical endometrial resection versus abdominal hysterectomy for the treatment of menorrhagia. Br J Obstet Gynaecol 1993;100:244–52.[Medline]
3. Crosignani PG, Vercellini P, Apolone G, De Giorgi O, Cortesi I, Meschia M. Endometrial resection versus vaginal hysterectomy for menorrhagia: Long-term clinical and quality-of-life outcomes. Am J Obstet Gynecol 1997;177: 95–101.[Medline]
4. Lethaby A, Shepperd S, Cooke I, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding (review). Cochrane Database Systematic Rev 2000;2:CD000329.
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18. Garratt AM, Ruta DA, Abdalla MI, Buckingham JK, Russell IT. The SF36 health survey questionnaire: An outcome measure suitable for routine use within the NHS? Br Med J 1993;306:1440–4.
19. Bhattacharya S, Mollison J, Pinion S, Parkin DE, Abramovich DR, Terry P, et al. A comparison of bladder and ovarian function two years following hysterectomy or endometrial ablation. Br J Obstet Gynaecol 1996;103: 898–903.[Medline]
20. Jequir AM. Urinary symptoms after total hysterectomy. Br J Urol 1976;46:437–41.
21. Vervest HAM, Kieweit de Jonge M, Vervest AMJS, Barents JW, Haspels AA. Micturition symptoms and urinary incontinence after non-radical hysterectomy. Acta Obstet Gynecol Scand 1988;67:141–6.[Medline]
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24. Sculpher MJ, Dwyer N, Byford S, Stirrat GM. Randomised trial comparing hysterectomy and transcervical endometrial resection: Effect on health related quality of life and costs at two years after surgery. Br J Obstet Gynaecol 1996;103:142–9.[Medline]
25. Hysteroscopic Surgery SIGN Guidelines. Scottish Intercollegiate Guidelines Network (SIGN), Publication No. 37. Edinburgh: Royal College of Physicians, 1999.
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