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ORIGINAL RESEARCH |
From the Department of Gynecology and Obstetrics, Holbaek County Hospital, Smedelundsgade 60, DK-4300 Holbaek, Denmark.
Address reprint requests to: Torben Philipsen, MD, Department of Gynecology and Obstetrics, Holbaek County Hospital, DK-4300 Holbaek, Denmark; E-mail: chtoph{at}vestamt.dk.
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ABSTRACT |
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 ABSTRACT MATERIAL AND METHODSRESULTSDISCUSSIONREFERENCES |
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METHODS: One hundred and twenty women requiring endometrial ablation for the treatment of heavy bleeding disorders entered the study. All patients were offered a clinical examination 24 months postoperatively and had a questionnaire by mail 5 years after the initial treatment. The number of complications during and after the operation, re-ablations, and hysterectomies were registered. A bleeding index and the patient satisfaction rate were stated.
RESULTS: Sixty-one patients were treated by endometrial coagulation, and 59 were treated by endometrial resection. No differences between the two groups were observed concerning fluid absorption, bleeding, perforation, and infection. At the 5-year follow-up, 64% of the patients had only one ablation, 15% were treated twice, 15% had a hysterectomy, and 6% were lost to follow-up. After 5 years, the bleeding index was halved in patients with menses. Seventy-nine percent of the women would recommend the treatment to their best female friend.
CONCLUSION: We found no significant differences in the frequency of complications. Only 15% of the women had a hysterectomy after 5 years. No significant difference was observed with respect to bleeding reduction and patient satisfaction in the two groups.
Many women suffer from bleeding abnormalities, especially from the age of 40 until menopause. The reason is often fibroids, hyperplasia of the endometrium, or dysfunctional bleeding due to abnormal function of the ovary. Previously, hysterectomy was the only surgical alternative to nonsurgical treatments such as hormones, antifibrinolytic treatment, or no treatment. Since the late 1980s, endometrial ablation has become increasingly more common in the treatment of abnormal bleeding. The procedure is performed as either endometrial coagulation or endometrial resection, or the endometrium is destroyed with yttrium aluminum garnet laser (YAG laser).1 More recently, the endometrium has also been ablated with a thermal balloon placed in the uterine cavity2 and by endometrial laser intrauterine thermo-therapy (ELITT).3
Hysteroscopic surgery has several advantages over hysterectomy. Some women prefer a treatment that does not include removal of the uterus. The risk of urinary tract lesion is very low. Blood loss is small, and transfusion rarely occurs. Serious infectious complications have been observed.4,5 In the short term, endometrial ablation is associated with lower morbidity than hysterectomy,6 but it has not been proved that the mortality risk is also lower. The mortality risk associated with hysterectomies is known and is low in the patient group for whom endometrial ablation is an alternative.7 There are also economic advantages with endometrial ablation because the number of days in the hospital is very few; in many cases surgery can be performed as an outpatient procedure, and the necessary recuperation is only a few days. However, randomized studies have shown that a majority of patients seem to be more satisfied after hysterectomy than after endometrial resection.6,8 How patient selection and endometrial ablation method influence the results after endometrial ablation has never been investigated. The present randomized, controlled study was undertaken to compare two well-established endometrial ablation methods, especially with regard to the satisfaction of the patient, rate of hysterectomy, and the complication rate after a period of at least 5 years.
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MATERIAL AND METHODS |
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The primary outcome parameter after the 5-year investigation was the rate of hysterectomies. With 60 patients in each group, 10% lost to follow-up, an 
error of .05, and a presumed mean frequency of hysterectomy at 15%, we are able to detect a difference greater than 19% in the frequency of hysterectomies with the power of 0.80. The 
2 and Mann-Whitney tests were used where appropriate. Percentage was taken of the number of patients randomized to the treatment indicated.
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RESULTS |
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In the groups generated by randomization, there were no significant differences in mean age, type of bleeding abnormality, number of years of bleeding problems, number of patients with pelvic pain, number of patients with submucous fibroids, or the depth of cavity (Table 1
). The median operative time for the coagulation group was 13 minutes, and it was 20 minutes for the resection group. We found a significant difference P < .05 (Mann-Whitney test).
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2 test P > .05). At the 5-year follow-up, 18 patients (15%) had a hysterectomy, ten from the coagulation group and eight from the resection group, 2 test P > .05 (Table 2).
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The indications for hysterectomy were bleeding abnormalities (n = 8) (one of these patients was planned as re-ablation, but her uterus was perforated), pain (n = 3), bleeding abnormalities and pain (n = 3), suspicion of stroma sarcoma (n = 1), sepsis (n = 1), anxiousness (n = 1), and unknown (n = 1). In seven patients the histology of the removed tissue demonstrated either endometriosis, adenomyosis, or both.
One patient’s uterus was perforated just before the ablation and was treated a month later as planned. In connection with a retreatment, another patient suffered a perforation. She had a hysterectomy. No intraoperative bleeding problems were observed, but one patient retained more than 1 L of fluid (this patient later developed sepsis and died).
The median bleeding index of the patients preoperatively was 36 days in 3 months in the coagulation group and 34 days in 3 months in the resection group. The corresponding values for the group of women still bleeding after 5 years were 16 days and 18 days in 3 months for the coagulation and resection groups, respectively (Table 3). The bleeding index included days with spotting—5 days in the coagulation group and 4 days in the resection group. There was no difference in bleeding indices between treatment groups preoperatively, 2 or 5 years postoperatively (Mann-Whitney test, P > .05).
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). No difference was observed between the number of infections in the coagulation group and the resection group. One patient died due to a fatal infection after fibroid resection and endometrial coagulation.5 She had not been treated with prophylactic antibiotics.
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2 test P > .05. Nine women (8%) would not recommend the treatment. Sixteen women did not answer this question or were lost to follow-up. Twelve patients would have preferred hysterectomy as the initial treatment. Seven out of these 12 patients had in fact a hysterectomy. |
DISCUSSION |
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No differences concerning complication rate, bleeding index reduction, or satisfaction rate were observed between the two methods. The satisfaction with the treatment is probably greatly influenced by patient selection; for example, if many women who have a uterus with intramural fibroids are treated, new problems are likely to appear later. Alternatively, if only patients with menorrhagia in the years just before menopause or only patients with a small uterus are treated, the satisfaction rate is likely to be much greater. In this study, the age of the patients, the number of patients with fibroids, and the number of patients with pelvic pain were alike in the two groups. Thus, there is no reason to think that these conditions might have influenced the result. On the other hand, comparisons in patients’ satisfaction between this study and other studies where hysterectomies have been performed are questionable. The patient selection for a study, even in a randomized trial, might greatly influence the result if the indications for the different treatments are not alike. During the period of this study, all patients who were referred with bleeding problems requiring surgical treatment and who otherwise fulfilled the inclusion criteria were offered the opportunity to participate in the study. Endometrial ablation performed after pretreatment with goserelin acetate was superior to endometrial ablation without pretreatment in the treatment of dysfunctional bleeding.11 Therefore, comparisons of patient satisfaction after hysterectomies and endometrial ablation without pretreatment6 might not be appropriate. Likewise, the pretreatment in this study with noretisterone, which is not as effective in endometrial thinning as goserelin, might favor the resection, for example, because endometrial coagulation might cause problems when the endometrium is thick.
The prophylactic antibiotic strategy was changed because of a serious infection in one patient, who died 3 days after her treatment due to disseminated intravascular coagulation.5 When the present study was planned, the risk of infection seemed of no great concern, and therefore no special precautions were taken besides the usual surgical hygiene. In the literature, there is no general opinion concerning the beneficial effect of prophylactic antibiotics in connection with hysteroscopic surgery, although another very serious infection has been described.4 In the first part of the study, only women who were particularly at risk, as evaluated by the surgeon, received prophylactic antibiotics. Still, the number of infections appears to be lower in the group of patients who received prophylactic antibiotics compared with the nontreated group, but the study was not intended to elucidate this point.
This study is too small to allow comparison of serious complications between the two methods. On the other hand, the treatment success rates for the two treatment types are so alike in this study that it seems likely that a very large study is required to demonstrate a difference in treatment success. The MISTLETOE study12 demonstrated that the complication frequencies are much lower with the coagulation method than with the resection procedure. Besides, in our experience, it is easier to learn the coagulation method than the resection method. The figures in our study concerning retreatment and hysterectomy frequencies and satisfaction rate are similar to those described by O’Connor et al,13 who performed the transvaginal procedures as resection. We agree with their statement that endometrial ablation is a good alternative to hysterectomy, but careful patient selection is important in improving the outcome.14 As in our study, Dutton et al also found an age-related risk of hysterectomy for patients treated with endometrial ablation.15 Concerning psychologic well-being, there also seems to be no difference between the patients who have undergone a hysterectomy versus patients who have had an endometrial ablation in long-term follow-up.16
In conclusion, no significant difference was observed in patient satisfaction rate and in bleeding reduction between patients treated for bleeding abnormalities with coagulation using a rollerball and with resection using a resection loop. No differences were observed in perioperative complication frequencies. After at least 5 years of observation, 15% of the women had a hysterectomy, and 79% of the women would recommend the treatment to their best female friend.
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Footnotes |
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Received August 7, 2001. Received in revised form December 13, 2001. Accepted January 23, 2002.
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REFERENCES |
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2. Neuwith R, Duran A-A, Singer A, Bolduc L. The endometrial ablator: A new instrument. Obstet Gynecol 1994;83: 792–6.[Abstract]
3. Donnez J, Polet R, Squifflet J, Rabinovitz R, Levy U, Ak M, et al. Endometrial laser intrauterine thermo-therapy (ELITT): A revolutionary approach to the elimination of menorrhagia. Curr Opin Obstet Gynecol. 1999;11(4): 363–70.[Medline]
4. Parkin DE. Fatal toxic shock syndrome following endometrial ablation. Br J Obstet Gynecol 1995;102:163–4.[Medline]
5. Joergensen JC, Pelle J, Philipsen T. Fatal infection following transvaginal fibroid resection. Endoscopy 1996;5: 245–6.
6. Dwyer N, Hutton J, Stirrat GM. Randomised controlled trial comparing endometrial resection with abdominal hysterectomy for the surgical treatment of menorrhagia. Br J Obstet Gynecol 1993;100:237–43.[Medline]
7. Loft A, Andersen TF, Broennum-Hansen H, Roepstorff C, Madsen M. Early postoperative mortality following hysterectomy. A Danish population based study 1977–1981. Br J Obstet Gynecol 1991;98:147–54.[Medline]
8. 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 two years after surgery. Br J Obstet Gynecol 1996; 103:142–9.[Medline]
9. Diem K. Documenta Geigy Scientific Tables. 6th edition. Basel, Switzerland: J.R. Geigy S.A., 1962.
10. Parkin DE. Endometrial resection and ablation: Past, present and future. Gynaecological Endoscopy 2000;9: 1–7.
11. Donnez J, Vilos G, Gannon MJ, Stampe-Soerensen S, Klinte I, Miller RM. Goserelin acetate (Zoladex) plus endometrial ablation for dysfunctional uterine bleeding: A large randomized, double-blind study. Fertil Steril 1997; 68:29–36.[Medline]
12. Overton C, Hargreaves J, Maresh M. A national survey of complications of endometrial destruction for menstrual disorders: The MISTLETOE study. Br J Obstet Gynecol 1997;104:1351–9.[Medline]
13. O’Connor H, Broadbent JAM, Magos AL, McPherson K. Medical research council randomized trial of endometrial resection versus hysterectomy in management of menorrhagia. Lancet 1997;349:897–901.[Medline]
14. Gandhi SV, Fear KBC, Sturdee DW. Endometrial resection: Factors affecting long-term success. Gynaecological Endoscopy 1999;8:41–50.
15. Dutton C, Ackerson L, Phelps-Sandall B. Outcomes after rollerball endometrial ablation for menorrhagia. Obstet Gynecol 2001;98:35–9.
16. Aberdeen Endometrial Ablation Trials Group. A randomized trial of endometrial ablation versus hysterectomy for the treatment of dysfunctional uterine bleeding: Outcome at four years. Br J Obstet Gynecol 1999;106:360–6.[Medline]
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