|
|
||||||||
ORIGINAL RESEARCH |
From the Clinica Ostetrica e Ginecologica "Luigi Mangiagalli", University of Milano and Istituti Clinici di Perfezionamento, Milano, Italy.
Address reprint requests to: Paolo Vercellini, MD Clinica Ostetrica e Ginecologica "Luigi Mangiagalli" Universita di Milano Via Commenda 12-20122 Milano Italy
| Abstract |
|---|
|
|
|---|
Methods: Premenopausal menorrhagic women with normal hysteroscopic and endometrial biopsy findings were allocated randomly to endometrial vaporization (n = 47) or resection (n = 44). Distension medium deficit, operating time, and degree of difficulty of the procedure were determined at surgery. Menstrual pattern of women in both groups was also assessed after 1-year follow-up.
Results: Mean ± standard deviation (SD) distension fluid deficit was 109 ± 126 mL in the vaporization and 367 ± 257 mL in the resection group (mean difference 258 mL; 95% confidence interval 175, 341 mL; P < .001, unpaired t test). Mean ± SD operating time was, respectively, 9.2 ± 3.1 minutes versus 10.7 ± 2.5 minutes. The surgeon classified intraoperative difficulties as none in 32, minimal in 11, moderate in four, and severe in none in the vaporization group, and 17, 14, seven, and six in the resection group. Menstrual pattern at 1 year in the former group was amenorrhea in 17 (36%) cases, hypomenorrhea or spotting in 20 (43%), normal flows in 10 (21%), and menorrhagia in none compared with, respectively, 21 (48%), 14 (32%), seven (16%), and two (5%) in the latter group.
Conclusion: Endometrial ablation with the vaporizing electrode limited fluid absorption compared with resection by the standard cutting loop. Long-term effects on uterine bleeding were similar.
Endometrial resection with a cutting loop is considered by many the standard reference technique for hysteroscopic treatment of abnormal uterine bleeding, but complications are frequent and a high level of surgical skill is necessary.16 In particular, excessive absorption of distension fluid through the sectioned myometrial veins remains a potentially severe problem.7,8 A spherical rollerball electrode that coagulates the tissues with immediate hemostatic vasoocclusion,9 which limits intravasation but is more time-consuming, might be suboptimal over the long-term, and excludes treatment of submucous myomas.10,11
A cylindrical, corrugated electrode or vaporizer (Vaportrode; Circon Acmi, Stamford, CT; Figure 1
) has been developed that, due to its peculiar physical characteristics, should allow fast and radical ablation of endometrium and myomas. The bar electrode has three grooves that provide eight edges along which electrons concentrate, allowing immediate cell vaporization on contact. We showed in vivo that a vaporizing electrode produces furrows of similar depth to those of a standard cutting loop.12 However, the depth of coagulation beneath the ablated area by the electrode is significantly greater compared with the loop.12
|
The vaporizing electrode appears to offer advantages over the cutting loop for hysteroscopic treatment of menorrhagia, so we conducted a randomized controlled trial to evaluate the effects of those two methods of endometrial ablation in women with dysfunctional uterine bleeding. The primary aim was to determine whether absorption of distension fluid was reduced in women who had endometrial vaporization compared with those who had classic endometrial resection. We also compared the technical feasibility of the two procedures in terms of length, degree of difficulty, and complications of the operation. Menstrual patterns in the groups were compared 1 year after surgery.
| Materials and Methods |
|---|
|
|
|---|
Women 35 years or older referred to our tertiary care center for hysterectomy for menorrhagia were considered for recruitment. Excessive uterine bleeding was diagnosed by history, serum hemoglobin, hematocrit and iron levels, and a pictorial blood assessment chart devised by Higham et al16 to evaluate menstrual flow. A monthly score of 100 or higher on the chart is significantly associated with a uterine blood loss of over 80 mL measured by the alkaline hematin method.16 Before randomization, each subject completed a menstrual diary card for two consecutive menses and had a complete physical examination, transvaginal ultrasonography, diagnostic hysteroscopy, and endometrial biopsy. Eligible subjects had uterine volumes less than a 12-week pregnancy, no evidence of atypical hyperplasia at endometrial biopsy, no adnexal tumors on clinical and ultrasonographic examination, and normal uterine cavity at hysteroscopy. Women uncertain about future children were excluded. Other exclusion criteria were recent use of hormonal agents or drugs that might affect menstrual blood loss, intramural or subserous myomas of 3 cm or more diameter, and unstable general conditions due to acute bleeding episodes. A depot preparation of GnRH agonist triptorelin was used preoperatively for 2 months to promote endometrial thinning, reduce fluid absorption, and facilitate intrauterine surgical conditions.17,18
After general anesthesia in the operating room, eligible subjects were randomized 1:1 to endometrial ablation with vaporizing electrode or endometrial resection with cutting loop. Treatment was allocated by a computer-generated randomization sequence using serially numbered, opaque, sealed envelopes, which were kept with the original randomization list by the ward sister, and not available to attending physicians.
In all cases, a 25-French gauge rigid resectoscope (G25-ST-CFR; Circon Acmi) and 12° fore-oblique telescope (M312; Circon Acmi) were used, equipped with a cylindrical, 3-mm-wide, vaporizing electrode (VE-B; Circon Acmi) or with a standard right-angle cutting loop electrode (MLE-24-015; Circon Acmi). After insertion of the resectoscope, the uterine cavity was distended with a nonconductive, hypoosmolar solution of 2.7% sorbitol and 0.54% mannitol, instilled under manometric control, with a pressure of 100120 mmHg generated by a pneumatic cuff for intrauterine irrigation and a vacuum of -30 to -40 mmHg applied for suction. Endometrial vaporization was done with pure cutting waveform current set at 200 watts power. The mucosa of the cornual areas was treated radially starting from the tubal ostia, withdrawing the electrode toward the surgeon at a speed of 11.5 cm/second, applying minimal pressure on the uterine wall. Vaporization was completed on the fundus and remaining cavity down to the isthmus. Resection was standard with cutting current set at 100 watts power. Treatment of cornual areas was completed with a 3-mm-diameter ball electrode and coagulating current set at 70 watts power.
To measure fluid deficit, a modification of the spring balance technique was adopted.1920 A 3-liter irrigating solution plastic bag with a pressure cuff was connected to the resectoscope by a fluid line and then hung on a clock balance (range 05 kg). The weight of the primed complete infusion set was 33003400 g. The outflow port of the hysteroscopic equipment was connected to a usual surgical closed-suction unit that collects aspirated fluid in plastic bags inside cylindrical, transparent, rigid containers with graduated volume marks along their lengths. Plastic draping commonly used in delivery rooms was placed under the subjects buttocks to funnel fluid escaping through the cervix into a calibrated pouch. Direct visual monitoring of the system allowed constant assessment of fluid balance during the procedure. To determine fluid input, residual weight indicated on the clock balance was subtracted from the initial reading before disconnecting the infusion bag from the resectoscope. The plastic bag of the suction unit and the cylindrical portion of the perineal draping were sealed and weighed together to measure fluid output. The difference between fluid input and output corresponds to the overall deficit.
Operating time was defined as the interval between the initial insertion and final removal of the instrument. After intervention, the surgeon classified the degree of difficulty of the procedure (based on ease and completeness of endometrial treatment and intracavitary bleeding) as none, minimal (same as routine), moderate (slightly more than usual), or severe (much more than usual). Intra- and postoperative complications were also recorded.
The women, aware of the technique used for endometrial ablation, had follow-up visits 1, 3, 6, 9, and 12 months after surgery, when gynecologic examinations were done, uterine bleeding histories and pictorial blood loss assessment charts were assessed, and adverse events were recorded. Serum hemoglobin, hematocrit, and iron levels were measured at baseline, 6, and 12 months. During the 12-month examination, subjects were asked to rate degree of satisfaction with their treatments on a five-level scale (very satisfied, satisfied, uncertain, dissatisfied, very dissatisfied). At the same time, a second-look diagnostic hysteroscopy with biopsy was offered to compare repair of the uterine cavity and assess presence, distribution, and histologic aspects of residual endometrium after the two surgical methods. Women were informed that the procedure was not likely to cause major modifications in management.
The sample was based on fluid absorption during endometrial ablation. According to our previous study,18 the standard deviation (SD) of the variable in women who had hysteroscopic resection after endometrial preparation with GnRH agonists was around 300 mL. A difference of 200 mL in fluid absorption between treatment groups was considered clinically relevant. To have an 80% chance of detecting such a difference at an overall significance level of 5%, about 40 subjects per study arm were required. Allowing for withdrawals, the aim was to recruit approximately 45 women per group. The statistical significance of differences in mean fluid absorption, operating time, and pictorial blood-loss assessment chart scores were analyzed by unpaired t test. The degrees of difficulty at intervention and satisfaction with treatment were compared by Fisher exact test. All statistical tests were two-sided. P < .05 was considered statistically significant. Confidence intervals (CIs) were calculated for some differences.
| Results |
|---|
|
|
|---|
|
|
|
|
| Discussion |
|---|
|
|
|---|
Fluid deficit was chosen as the primary outcome of interest because excessive absorption of irrigating solutions remains the most frequent, enigmatic, and severe intraoperative complication of endometrial ablation.7,8,23 Some fluid was inevitably lost on the floor and in the surgical drapes, influencing the precision of estimates of fluid deficit calculated with our method. Great attention was paid to limit that loss, which is unavoidable and common to all systems of measuring intrauterine infusion volumes.
Endometrial vaporization was significantly easier than resection. Admittedly, this finding is weakened by the open-label design with highly subjective and potentially biased global assessments of operating conditions. The surgeon was obviously not masked to electrode used, which could have influenced data collection. Dichotomizing data in two hard outcomes (none and minimal difficulty versus moderate and severe difficulty) should have limited the effect of subjectivity; however, the main outcome measure of the study was fluid deficit, which can be considered more objective. The slight, statistically significant, between-group difference in operating time is probably of no practical benefit. The mean operating time in the resection group was only 10.7 minutes, despite moderate to severe difficulty in 30% of procedures, which might be explained by experience gained in dealing quickly with difficult cases, to limit fluid absorption, and by avoidance, whenever possible, of repeated interruptions to remove endomyometrial fragments.
We hypothesized that the greater depth of coagulation beneath furrows obtained with the vaporizer should have resulted in a greater reduction in monthly blood loss. Unexpectedly, the effect on menstrual flows was almost identical in the two groups 1 year after surgery. A possible explanation is that residual endometrium left at the internal cervical os might colonize the ablated uterine cavity and cover it partially or totally, independent of the depth of destruction achieved by the procedure. That is substantiated by similar observations at second-look hysteroscopies and finding a limited amount of endometrium in most histologic specimens. Satisfaction was very high in both groups, and although long-term results might vary, there was no evidence of a potentially less favorable outcome after endometrial resection. Subjects awareness of the technique might have favored the new operation, but adoption of a reliable semiquantitative method to assess postsurgical menstrual blood loss and objective measurements such as serum hemoglobin, hematocrit, and iron values should have limited that bias. In our experience, complete absence of menstrual flow after endometrial ablation is not always the most desirable outcome. Women might dislike postoperative amenorrhea because they lack proof of not being pregnant or they feel it is not physiologic, which might explain why only 9% of women allocated to resection were very satisfied at 1 year, whereas 48% of them were amenorrheic.
The electrical density sufficient for physical elimination of tissue and underlying coagulation required use of high power.1215 In theory, holding the activated electrode steady in the cornual recesses for a long time might be dangerous and lead to transmyometrial transmission of energy. Because of that risk, common to the rollerball electrode,9 cutting loop,21,24 and neodymium: yttrium-aluminum-garnet (Nd-YAG) laser,25 keeping vaporizer moving is recommended when activating the electrogenerator. Applying pure undampened current should limit thermal necrosis diffusion compared with the coagulation modality.26 An in vivo histochemical study found no sign of tissue damage approaching the uterine serosa.12 In our department, in which more than 150 endometrial vaporizations have been done since 1995, no complications have developed due to application of electricity.
Vaporization, like all the ablative techniques except resection, does not allow endometrial sampling; therefore, thorough preoperative histologic mucosal evaluation is mandatory.
We believe the vaporizing electrode is advantageous for endometrial ablation because it is as rapid and effective as the loop and as simple and safe as the rollerball. Similar results are probably obtainable with the Nd-YAG laser,27 but at greatly increased costs. It would be interesting to compare the safety, ease, efficacy, tolerability, and costs of hysteroscopic vaporization with those of thermal balloon endometrial ablation, a technique that is gradually gaining popularity for treating menorrhagia not associated with organic lesions.2830
| Footnotes |
|---|
Received October 22, 1998. Received in revised form February 26, 1999. Accepted March 11, 1999.
| References |
|---|
|
|
|---|
2. OConnor H, Broadbent JA, Magos AL, McPherson K. Medical Research Council randomised trial of endometrial resection versus hysterectomy in management of menorrhagia. Lancet 1997;349: 897901.[Medline]
3. Crosignani PG, Vercellini P, Apolone G, De Giorgi O, Cortesi I, Meschia M. Endometrial resection versus vaginal hysterectomy for menorrhagia. Am J Obstet Gynecol 1997;177:95101.[Medline]
4. Crosignani PG, Vercellini P, Mosconi P, Oldani S, Cortesi I, De Giorgi O. A levonorgestrel-releasing intrauterine device versus hysteroscopic endometrial resection in the treatment of dysfunctional bleeding. Obstet Gynecol 1997;90:25763.[Abstract]
5. Scottish Hysteroscopy Audit Group. A Scottish audit of hysteroscopic surgery for menorrhagia: Complications and follow-up. Br J Obstet Gynaecol 1995;102:24954.[Medline]
6. Overton C, Hargreaves J, Maresh M. A national survey of the complications of endometrial destruction for menstrual disorders: The MISTELTOE study. Br J Obstet Gynaecol 1997;104:13519.[Medline]
7. Istre O, Skajaa K, Schoensbye A, Forman A. Changes in serum electrolytes after transcervical resection of endometrium and submucous fibroids with use of glycine 1.5% for uterine irrigation. Obstet Gynecol 1992;80:21822.
8. Witz CA, Silverberg KM, Burns WN, Schenken RS, Olive DL. Complications associated with the absorption of hysteroscopic fluid media. Fertil Steril 1993;60:74556.[Medline]
9. Valle RF. Rollerball endometrial ablation. Baillières Clin Obstet Gynaecol 1995;9:299316.
10. Chullapram T, Song LY, Fraser IS. Medium-term follow-up of women with menorrhagia treated by rollerball endometrial ablation. Obstet Gynecol 1996;88:716.[Abstract]
11. Unger JB, Meeks GR. Hysterectomy after endometrial ablation. Am J Obstet Gynecol 1996;175:14327.[Medline]
12. Vercellini P, Oldani S, Milesi M, Rossi M, Carinelli S, Crosignani PG. Endometrial ablation with a vaporizing electrode. I. Evaluation of in-vivo effects. Acta Obstet Gynecol Scand 1998;77:6837.
13. Vercellini P, Oldani S, De Giorgi O, Milesi M, Merlo D, Crosignani PG. Endometrial ablation with a vaporizing electrode. II. Clinical outcome of a pilot study. Acta Obstet Gynecol Scand 1998;77:68893.[Medline]
14. Brooks PG. Resectoscopic myoma vaporizer. J Reprod Med 1995; 40:7915.[Medline]
15. Kaplan SA, Te AE. Transurethral electrovaporization of the prostate: A novel method for treating men with benign prostatic hyperplasia. Urology 1995;45:56672.[Medline]
16. Higham JM, OBrien PMS, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 1990;97: 7349.[Medline]
17. Brooks PG, Serden SP, Davos I. Hormonal inhibition of the endometrium for resectoscopic endometrial ablation. Am J Obstet Gynecol 1991;164:16018.[Medline]
18. Vercellini P, Perino A, Consonni R, Trespidi L, Parazzini F, Crosignani PG. Treatment with a gonadotropin-releasing hormone agonist before endometrial resection: A multicentre randomised controlled trial. Br J Obstet Gynaecol 1996;103:5628.[Medline]
19. Ankum WM, Vonk J. The spring balance: A simple monitoring system for fluid overload during hysteroscopic surgery. Lancet 1994;343:8367.[Medline]
20. Chandler CJ, Ford PM. Monitoring of fluid overload during hysteroscopic surgery. Lancet 1994;343:1368.[Medline]
21. Sutton CJG, Macdonald R, Magos AL, Broadbent JAM. Endometrial resection. In: Lewis BG, Magos AL, eds. Endometrial ablation. Edinburgh, UK: Churchill Livingstone, 1993:91131.
22. Onbargi LC, Hayden R, Valle RF, Del Priore G. Effect of power and electrical current density variations in an in vitro endometrial ablation model. Obstet Gynecol 1993;82:9128.
23. Baskett TF, Farrell SA, Zilbert AW. Uterine fluid irrigation and absorption in hysteroscopic endometrial ablation. Obstet Gynecol 1998;92:9768.[Abstract]
24. Duffy S, Reid PC, Smith JHF, Sharp F. In vitro studies of uterine electrosurgery. Obstet Gynecol 1991;78:21320.
25. Garry R. Good practice with endometrial ablation. Obstet Gynecol 1995;86:14451.[Abstract]
26. Soderstrom R. Principles of electrosurgery as applied to gynecology. In: Rock JA, Thompson JD, eds. Te Lindes operative gynecology. 8th ed. Philadelphia: Lippincott-Raven, 1996:32136.
27. Garry R, Shelley-Jones D, Mooney P, Phillips G. Six hundred endometrial laser ablations. Obstet Gynecol 1995;85:249.[Abstract]
28. Singer AA, Almanza R, Gutierrez A, Haber G, Bolduc L, Neuwirth RS. Preliminary clinical experience with a thermal balloon endometrial ablation method to treat menorrhagia. Obstet Gynecol 1994;83:7324.[Medline]
29. Neuwirth RS, Duran AA, Singer A, MacDonald R, Bolduc L. The endometrial ablator: A new instrument. Obstet Gynecol 1994;83: 7926.[Medline]
30. Amso NN, Stabinsky SA, McFaul P, Blanc B, Pendley L, Neuwirth R. Uterine thermal balloon therapy for the treatment of menorrhagia: The first 300 patients from a multi-centre study. Br J Obstet Gynaecol 1998;105:51723.[Medline]
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |