Endometrial Ablation: Complications and Outcome

' ' ' ' ' '

GYNAECOLOGY

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ENDOMETRIAL ABLATION: COMPLICATIONS AND OUTCOME S.A. Farrell, MD, FRCSC, T.F. Baskett, MB, FRCSC,

Departments of Gynaecology, Halifax Infirmary and, Obstetrics and Gynaecology, Dalhousie University ABSTRACT

Objective: to review the peri-operative complications and outcome of endometrial ablation. Design: review of 100 consecutive endnmetrial ablations using electrosurgery. Setting: teaching hospital. Patients: one hundred patients with disabling dysfunctional uterine bleeding, unresponsive to medical therapy, who chose endometrial ablation instead of hysterectomy. Results: peri-ojxrative complications were minimal with the exception of one uterine perforation resulting in hysterectomy. The shortterm success rate of surgery was 90 jJercent. Life table analysis suggests that lry thirty months, success rates will have declined to 65 percent. Conclusions: endometrial ablation using electrosurgery has a low rate of peri-operative complications. Short-term success rates are high but life table analysis suggests long-term success rates may be much lower. RESUME

Objectif: Analyser les complications peri-operatoires et les resultats de !'ablation de l'endometre. Plan d' experience : Analyser 100 cas consecutifs d' ablation de l' endometre par electrochirurgie. Cadre : HojJital universitaire. Patientes : Cent patientes souffrant d'hemrmagies uterines dysfonctionnelles invalidantes, ne reagissant pas a Ia therapie medicale et qui ant tmifere l' ablation de l' endometre al' hysterectomie. Resultats : Les complications peri-operatoires ant ete minimes, al' excejJtion d' une perforation de l' uterus qui a entrafne l'hysterectomie. Le taux de reussite chirurgicale acourt terme a ere de 90 %. D' apres l' analyse de Ia table de vie, on peut cons tater qu' a trente mois, le taux de succes aura baisse a65 %. Conclusions : L' ablation de l' endometre par electrochirurgie ne comporte qu' un faible taux de complications peri-operatoires. Les taux de succi's acourt terme sont eleves' mais d' apres l' analyse de Ia table de survie' les taux de reussite along terme pourraient etre beaucoup plus faibles.

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KEY WORDS

Endometrial ablation, complications, outcome. Received on October lOth, 1995. Revised and accepted on November 1st, 1995.

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1996;18:223-32

' ' ' Prior to endometrial ablation, patients were presented with a detailed informed consent which included the following points: 1) prediction of operative outcome. We quote the following outcome rates: 25 to 3 5 percent amenorrhoea, 50 to 60 percent reduced menses, and a ten percent failure rate." Long-term success rates are lower. 2) permanent sterilization is recommended. 3) operative complication rates: fluid overload (1-2% ), 9 uterine perforation ( 1'Yc,), 1''· 11 · 12 haemorrhage ( 1%), extra-uterine pelvic organ injury ( < 1% ). 4) patients are prepared for the possibility of laparotomy and hysterectomy. 5) after endometrial ablation, post-menopausal hormone replacement should include a progestin to accompany the estrogen. Pre-operative medical preparation to decrease the thickness of the endometrium was recommended. Perioperative antibiotic prophylaxis was given as a single ( 1 gram) intravenous dose of ampicillin. The procedure was undertaken under general anaesthesia. After dilatation of the cervix to number 10 to 11 Hegar, a 2 7 French Storz uterine resectoscope attached to a camera and monitor was introduced into the uterine cavity. Irrigation was gravity fed from a 2. 7 percent sorbitol 0.54 percent mannitol solution in three litre bags elevated to approximately one metre above the patient. A careful running tally of fluid balance was maintained. Guidelines for management of fluid overload were as follows: 1) for :2: 1,500 ml, intravenous furosemide 20 to 40 mg was given and the procedure was completed as quickly as possible, 2) for :2: 2,000 ml, intravenous furosemide was given and the procedure was discontinued. Patients experiencing fluid overload had a Foley catheter inserted, electrolyte levels were determined, and patients were monitored closely in the recovery room for signs of pulmonary oedema. The electrosurgical unit was set at 100 watts for both coagulation and cutting currents with blend one. The endometrium was systematically treated from the uterine fundus down to the level of the internal cervical os using various combinations of roller ball (37 patients), loop (20 patients), and combined loop and roller ball (43 patients) cautery attachments. Postoperatively, patients

INTRODUCTION

In 1981, Goldrath first reported the successful treatment of dysfunctional uterine bleeding by hysteroscopic endometrial ablation. 1 Previous attempts to ablate the endometrium by the blind introduction of probes or chemicals into the uterine cavity were unreliable and caused morbidity. 2 Goldrath used the neodymium: YAG laser to coagulate the endometrium systematically under direct hysteroscopic guidance. In 1987, DeCherney modified the surgical technique, using a urological resectoscope to excise the endometrium. 3 Further modifications were introduced by Vancaillie 4 with the roller ball cautery attachment, and by Townsend with the fenestrated outflow sheath.' By dispensing with the requirement for an expensive laser, the development of electrosurgical instruments made widespread adoption of hysteroscopic endometrial ablation feasible. Initially, endometrial ablation was offered only as an alternative to conservative management in patients with medical or surgical contra-indications to hysterectomy.' As endometrial ablation can usually be performed as an outpatient procedure with more rapid return to normal activities when compared to hysterectomy, the procedure gained popularity and is now offered to patients considering hysterectomy for dysfunctional uterine bleeding. As new techniques require careful evaluation, a pilot project of endometrial ablation was undertaken by the two authors in our centre. 6 In this report, we review the results of the first 100 procedures. MATERIALS AND METHODS

From September 1990 to May 1994, one hundred patients with dysfunctional uterine bleeding underwent endometrial ablation. In order to assess the safety of the procedure, the first ten patients were observed overnight postoperatively in hospital. Subsequently, hospital admission was restricted to patients with significant medical problems. Criteria for endometrial ablation were as follows: 1) disabling dysfunctional uterine bleeding unresponsive to medical therapy; 2) no pelvic or intra-uterine lesions other than small ( < 3 em) submucous fibroids or endometrial polyps; 3) uterine cavity sounded to < 10 em, and 4) benign endometrial histological findings in samples taken within the last six months.

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What would a major advancement • mean tn the treatm ent of osteoporosis?

' ' ' were discharged from the recovery room, given oral analgesics, and instructed to report excessive bleeding, abdominal pain or fever. An appointment was given for outpatient review in six weeks.

TABLE 2

RESULTS

Fluid Overload

PERI-OPERATIVE COMPLICATIONS OF ENDOMETRIAL ABLATION (No=%)

Between September 1990 and May 1994, one hundred patients underwent endometrial ablation. The mean age was 39 years (range 27 to 52 years). Ninetyseven had dysfunctional uterine bleeding and three, postmenopausal bleeding. In eleven, there was a medical and/or surgical contra-indication to hysterectomy: obesity (4 ), severe asthma (2), coagulation disorder (2), central shunt (1), extensive pelvic adhesions (1), and amyotrophic lateral sclerosis (1). After the initial10 patients, only seven of the next 90 patients were admitted pre-operatively for associated medical conditions. The pre-operative medical preparation of the endometrium is listed in Table 1. Intra-uterine findings included fifteen endometrial polyps, three submucous fibroids, and one septum. Additional procedures at the time of endometrial ablation included thirteen laparoscopic tubal ligations, one diagnostic laparoscopy, and a labial resection. The mean operative time was 49 minutes (range 23 to 135 mins). Mean fluid volume used was 7,674 ml (range 2,800 ml to 15,200 ml). Peri-operative complications are listed in Table 2. The uterine perforation was suspected because of a positive fluid balance of 3, 700 ml. Laparotomy was performed, extra-uterine damage ruled out, and abdominal hysterectomy performed. Two patients had fluid overload > 2,000 ml. One developed transient pulmonary oedema and the other had hyponatraemia (serum sodium 119 mmol/L) requiring intravenous correction. Correlation coefficients were calculated for a number of factors which might have contributed to fluid overload. Operating time was found to

4

GnRH Analogue None

2

4

correlate most closely, with a coefficient of0.47. Two patients were kept postoperatively for medical management of pre-existing coagulopathy. Four patients had postoperative endomyometritis; two were readmitted to hospital for intravenous antibiotics and two were treated as outpatients. One of these patients also developed symptoms of partial small bowel obstruction which resolved with conservative management. One patient continued to experience chronic pelvic pain and eventually opted for hysterectomy. During the first six-month follow-up period, 90 percent of patients had a successful result from their surgery which was defined as either amenorrhoea or menstrual flow perceived by the patient to be normal. Five patients had immediate failures, three were lost to follow-up, and two patients underwent hysterectomy, one for perforation at the time of ablation and the other experienced persistent pelvic pain attributed to the uterus. Postoperative menstrual patterns at six months were as follows: amenorrhoea- 27 percent, spotting- 25 percent, normal menstrual flow- 38 percent, and persistent menorrhagia- five percent. The predictive value of the menstrual pattern at six months was evaluated. The long-term failure rates in the groups which experienced amenorrhoea or spotting during the first six-month follow-up were comparable at seven to eight percent. The long-term failure rate in the group experiencing normal flow during the first six months was 16 percent, twice the rate of the other two groups (Table 2). We studied the effects of pre-operative medical preparation of the endometrium on endometrial thickness at the time of surgery, surgical success rates, and fluid balance. Fifty-two percent ( 12 of 23) of the patients who

4

23 100

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2

Peri-operative Haemorrhage

21

63 6

2

Uterine Perforation

(No=%)

Medroxyprogesterone

4

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Hyponatraemia

Endomyometritis

PRE-OPERATIVE MEDICAL PREPARATION FOR ENDOMETRIAL ABLATION

Combination Oral Contraceptive

6

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TABLE 1

Danazol

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FOSAMAX® is a bone metabolism regulator. FOSAMAX® is indicated for the treatment of osteoporosis in postmenopausal women. • Bone Mineral Density •• In clinical studies, over 96% of patients studied for up to three years had a measured increase in spine BMD. 1 t FOSAMAX® I 0 mg daily produced statistically significant and clinically important increases in BMD at the hip, spine, and wrist (ultradistal forearm) relative to placebo at three years (po£0.001).'' t Combined data from two large, identically designed, double-blind, placebo-controlled, three-year multicenter studies in 994 women with osteoporosis, defined as low bone mass, 397 received placebo and 196 of whom received FOSAMAX® I 0 mg/day. To ensure an adequate calcium intake, all patients were supplemented with 500 mg of calcium per day. 1 I Liberman UA eta\. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Eng\ I Med 1995;333(22): 1437-43. 2. Data on file, Merck Frosst Canada Inc: Two double-blind, randomized, placebo-controlled, parallelgroup, multicenter studies to evaluate the safety and effect on bone density of daily oral MK-217 for two years in osteopenic postmenopausal women. with a one-year open treatment extension [Protocol No. 035 (US) and 037 (lnternational)J-Three Year Data.

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' ' ' received no preparation were found to have thick endometrium at the time of surgery compared to a 25 percent (19 of 77) rate in those who had had pre-operative medical preparation (chi square p < 0.001 ). In the initial six-month follow-up, success rates for the two groups were as follows: no pre-operative treatment, 95 percent; preoperative medical treatment, 90 percent. Over the longer term, 26 percent (6 of 23) patients without medical preparation experienced recurrent heavy bleeding. Excluding the two patients who underwent hysterectomy

in the peri-operative period, and including the three patients lost to follow-up as failures, 16 percent (12 of 75) of patients who used medical preparation pre-operatively experienced recurrence of heavy bleeding. This difference did not achieve statistical significance (chi square with Yates connection p = 0.06). Pre-operative medical preparation did not have a significant effect on fluid balance. Table 3 shows the results of life table analysis of surgical outcomes. The table includes as failures the 17 patients who have sought further therapy. Patient numbers beyond 30 months of TABLE3 follow-up are too small to be credited with LIFE TABLE ANALYSIS OF LONG-TERM SUCCESS RATES FOLLOWING ENDOMETRIAL ABLATION significance. This table clearly indicates that the successful surgical outcome Time in Under Failure Withdrawn Cummulative Probability Months Observation of Continued Success achieved during the first six to twelve 0-6 100 7 20 0.933 months is not maintained over the long 6- 12 19 0.907 73 2 term. Figure 1 graphically displays the 12- 18 52 1 13 0.888 outcome of life table analysis. 18- 24 38 5 18 0.723 Some authors have noted better long24-30 15 9 0.658 term success rates in older patients. 13 Fifty30-36 5 1 2 0.493 one of our patients were < 40 years of age. 36-42 0.493 2 0 This group had an overall success rate of 80 42-48 0 0.493 percent. When compared to the overall success rate of 86 percent experienced by the forty-five patients > 40 years, there was TABLE4 no significant difference (chi square test). RESULTS OF ENDOMETRIAL ABLATION USING ELECTROCOAGULATION Life table analysis was done for these two (1394 PATIENTS) age subgroups. The group < 40 years Author No. of Amenorrhoea Bleeding$ Failure Percent showed a higher incidence of earlier failure Success Patients Normal Menses 100% DeCherney 19 18 0 followed by a plateau at a 60 percent suc15 10 4 93% Vancaille 1 cess rate at two years. The group aged~ 40 100% 50 35 15 Townsend 0 years experienced a more gradual decline Derman 62 23% 77% in success rates reaching a low of 40 percent 250 10% 90% Magos at three years. 21 Pyper 80 6 48 72% Twenty patients were dissatisfied with 90% 12 Lefler 6 2 20 the results of their surgery at the time of 100% 12 8 4 Mclucas 0 this analysis. The reasons for dissatisfac88% 15 20 Petrucco 40 5 tion included the following: recurrent dysMaher 21 66 11 89% 100 functional bleeding (15), disabling 100% Brooks+ 26 23 3 0 dysmenorrhoea ( 1) , persistent discharge 87 Wortman 57% 40% 3 97% (1), severe PMS (1), persistent pain (1), 94% 77 Fraser 25% 69% 6 90% 61 18 37 Daniell 6 and perforation at the time of ablation Rankin 396 15% 85% (1). These patients were managed in the Dwyer 99 15% 85% following way; hysterectomy ( 11), repeat Nicholson 376 38% 62% endometrial ablation (2), further medical + patients > 50 years of age. therapy ( 4), and observation (3).

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48% reduction in the proportion of patients treated with FOSAMAX® experiencing one or more vertebral fractures relative to those treated with placebo in pooled analysis (5~20 rng) (p=0.034) I,~

Low bone mass is a major predictor of increased risk of osteoporotic fractures 3

'I[ Vertebral fractures occurred in 6.2% (22/355) of patients who received placebo and 3.2% ( 17/526) of patients who received FOSAMAX® (5 or 10 mg for 3 years or 20 mg for 2 years followed by 5 mg for I year).' 3. Consensus Development Conference: Diagnosis, prophylaxis, and treatment of osteoporosis. Am I Med 1993;94:646-9.

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' ' ' FIGURE 1

effect of danazol on the endometrium is less consistent but treatment results are good." A significant proportion of our patients could not afford to take the pre-operative medication and, thus, served as a control group. They did not differ in any significant way from the patients who received pre-operative medical preparation. In this study, patients who received pre-operative medical preparation did not experience higher rates of long-term cure. Unlike reports from other authors, perimenopausal status did not seem to confer a better chance of long-term success. 11 Proposed modifications in surgical technique have included pre-operative curettage, the injection of intracervical vasopressin, 21 and a more complete resection of the endometriumY These modifications await confirmation by further studies. Several authors have reported the successful outcome of endometrial ablation using the uterine resectoscope (Table 4). n,;,Jl,l 111 The mean duration of follow-up in

GRAPHIC DEPICTION OF ENDOMETRIAL ABLATION LIFE TABLE ANALYSIS

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Time (months)

DISCUSSION

Since Goldrath's initial report,' endometrial ablation has been increasingly accepted as an alternative to hysterectomy for dysfunctional uterine bleeding. Implementation of training guidelines in our centre has resulted in a low incidence of serious peri-operative complications. Uterine perforation is the most serious potential complication and is more common when the loop attachment of the resectoscope is used. Unfortunately, despite the best efforts to achieve a thin endometrium prior to surgery, some patients continue to present at the time of surgery with thick endometrium which can only be managed successfully by resection using the loop attachment. As a compromise, the authors have used the roller ball to treat the fundal and cornual areas (the most common sites of perforation) and have switched to the loop to resect the remaining endometrium. Fluid overload occurred more often than perforation in this study. Even with careful monitoring, rapid fluid absorption sometimes occurs and serious complications have been reported. 14·'' Our analysis shows that the duration of the procedure correlates most closely with the volume of fluid absorption. Other studies have suggested that intra-uterine pressures play a significant role.'' We did not apply pressure to our fluid infusion system, but relied upon gravity alone to provide sufficient fluid pressure to keep the uterine cavity distended. To improve the outcome of endometrial ablation, most authors recommend pre-operative medical preparation of the endometrium. 17 ·18' 19 The GnRH analogues have produced consistent pre-operative atrophy of the endometrium and high rates of amenorrhoea.''·' 8 The

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these reports, excluding the studies by Derman and Nicholson, was 10 months (range 4 to 24 months). Although these reports reflect accurately the risk of perioperative complications, the short duration of follow-up and lack of life table analysis severely limits their usefulness in predicting long-term success rates. Derman reported a life table analysis on 62 patients. n Defining failure as the need for further surgery, his success rate at three years was 91 percent. Nicholson reported an overall success rate of 62 percent in 500 patients whose follow-up ranged from six months to five years. 11 The results of our life table analysis which included all patients who were dissatisfied enough to seek further therapy, predict a success rate similar to that of Nicholson. Although our life table analysis suggests that enthusiastic projections of long-term success must be tempered, further treatment modifications may improve results. Changes in pre-operative medical preparation, the addition of postoperative medical therapy, and changes in surgical technique may improve the long-term outcome. From the perspective of many patients, endometrial ablation is an attractive alternative to hysterectomy. Most patients were impressed by the minimal impact of the procedure. They experienced only mild postoperative cramping and minimal discharge. Although all patients were given a prescription for a codeine containing analgesic, few needed to take it. Those patients who encountered postoperative problems presented shortly after the procedure and were treated appropriately with

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has been evaluated for safety in clinical studies in 994 postmenopausal patients. ~The overall safety profiles of FOSAMAX® 10 mg per day and placebo were similar. ~Adverse

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' ' ' 16. Vulgaropulos SP, Haley LC, Hullka JF. Intrauterine pressure and fluid absorption during continuous flow hysteroscopy. Am J Obstet Gynecol 1992;167:386-91. 17. Serden SP, Brooks PG. Preoperative therapy in preparation for endometrial ablation. J Reprod Med 1992;37:679-81. 18. Brooks PG, Serden SP, Davos I. Hormonal inhibition of the endometrium for retroscopic endometrial ablation. Am J Obstet Gynecol 1991 ;164:1601-8. 19. Lewis BV. Guidelines for endometrial ablation. Br J Obstet Gynaecol 1994; 101 :470-3. 20. Gimpelson RJ, Kaigh J. Mechanical preparation of the endometrium prior to endometrial ablation. J Rep rod Med 1992;37:691-4. 21. Lefler HT, Sullivan GH, Hullka JF. Modified endometrial ablation: electrocoagulation with vasopressin and suction curettage preparation. Obstet Gynecol1991 ;77:949-53. 22. Wortman M, Daggett A. Hysteroscopic endomyometrial resection: a new technique for the treatment of menorrhagia. Obstet Gynecol 1994;83:295-8. 23. Rankin L, Steinberg LH. Transcervical resection ofthe endometrium: a review of 400 consecutive patients. Br J Obstet Gynaecol 1992;91 :911-4. 24. Mclucas B. Endometrial ablation with the roller ball electrode. J Reprod Med 1990;35:1055-8. 25. Petrucco OM, Gillespie A. The neodymium YAG laser and the resectoscope for the treatment of menorrhagia. Med J Aust 1991 ;154:518-9. 26. Maher PJ, Hill DJ. Transcervical endometrial resection for abnormal uterine bleeding- report of 100 cases and review of the literature. Aust NZ J Obstet Gynaecol 1990;30:357 -60. 27. Brooks PG, Serden SP. Endometrial ablation in women with abnormal uterine bleeding aged fifty and over. J Reprod Med 1992;37:682-5. 28. Wortman M, Dagge HA. Hysteroscopic management of intractable uterine bleeding. J Reprod Med 1993;38: 505-10. 29. Fraser IS, Angsuwathana S, Mahmoud F, Yezerski S. Short and medium term outcomes after roller ball endometrial ablation for menorrhagia. Med J Aust 1993;158:454-7. 30. Daniell JF, Kurtz BR, Ke RW. Hysteroscopic endometrial ablation using roller ball electrode. Obstet Gynecol 1992;80:329-32. 31. Dwyer N, Hulton J, Stirrat GM. Randomized controlled trial comparing endometrial resection with abdominal hysterectomy for surgical treatment of menorrhagia. Br J Obstet Gynaecol1993;100:237-43. 32. Pyper RJD, Haeri AD. A review of 80 endometrial resections for menorrhagia. Br J Obstet Gynaecol 1991 ;98: 1049-54. 33. Derman SG, Rehnstrom J, Neuwirth RS. The long-term effectiveness of hysteroscopic treatment of menorrhagia and leiomyomas. Obstet Gynecol1991 ;77:591-4.

no long-term complications. Outpatient treatment, minimal postoperative discomfort, and early return to work are features of endometrial ablation which continue to appeal to the patient. Even if only 50 percent of the patients treated by endometrial ablation avoid hysterectomy, the cost savings to the health care system will be significant. REFERENCES 1.

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Goldrath MH, FullerTA, Segal S. Laser photo vaporization of the endometrium for treatment of menorrhagia. Am J Obstet Gynecol 1981 ;140:14-9. Droegemueller W, Makowski E, Macsallea R. Destruction of the endometrium by cryosurgery. Am J Obstet Gynecol1971;110:467-9. DeCherney AH, Diamond MP, Lavy G, Polan ML. Endometrial ablation for intractable uterine bleeding: hysteroscopic resection. Obstet Gynecol1987;70:665-70. Vancaillie TG. Electrocoagulation of the endometrium with the ball-end resectoscope. Obstet Gynecol 1989; 7 4:425-7. Townsend DE, Richart RM, Paskowitz RA, Woolfork RE. "Rollerball" coagulation of the endometrium. Obstet Gynecol 1990; 76:31 0-13. Farrell SA, Baskett TF. Endometrial ablation for dysfunctional uterine bleeding. J SOGC 1992;14:31-7. Magos AL, Baumann R, Lockwood GM, Turnbull AC. Experience with the first 250 endometrial resections for menorrhagia. Lancet 1991 ;337:1074-8. Mongelli JM, Evans AJ. Pregnancy after transcervical endometrial resection. Lancet 1991 ;338:578-9. Chui PT, Short TG, Leung AKL, Tan PE, Oh TE. Systemic absorption of glycine irrigation solution during endometrial ablation by transcervical endometrial resection. Med J Aust 1992;157;667-9. Taylor PJ, Frinton V, MacFarlane JK. Uterine and bowel perforation during hysteroscopic endometrial resection: a case report. J SOGC 1992;14:98-9. Broadbent JAM, Molnar BG, Cooper MJW, Magos AL. Endoscopic management of uterine perforation occurring during endometrial resection. Br J Obstet Gynaecol 1992;99:1018. ltzkowic D, Beale M. Uterine perforation associated with endometrial ablation. Aust NZ J Obstet Gynaecol 1992;32:359-61. Nicholson SC, Slade RJ, Ahmed AIH, Gillmer MDG. Endometrial resection in Oxford: the first 500 cases- a five year follow-up. Br J Obstet Gynaecol 1995;15:38-43. Morrison LMM, Davis J, Sumner D. Absorption of irrigating fluid during laser photocoagulation of the endometrium in the treatment of menorrhagia. Br J Obstet Gynaecol 1989;96:346-52. Arieff AI, Ayus JC. Endometrial ablation complicated by fatal hyponatremic encephalopathy. JAMA 1993; 270:1230-2.

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