EDITORS’ CHOICE
Hysteroscopic endometrial resection versus laparoscopic supracervical hysterectomy for menorrhagia: A prospective randomized trial Errico Zupi, MD,a Fulvio Zullo, MD,b,c Daniela Marconi, MD, PhD,a Marco Sbracia, MD,d Massimiliano Pellicano, MD,c,e Eugenio Solima, MD, PhD,a and Giuseppe Sorrenti, MDa Rome, Catanzaro, and Naples, Italy OBJECTIVE: This study was undertaken to compare the relative efficacy and safety of hysteroscopic endometrial resection and laparoscopic supracervical hysterectomy in the treatment of abnormal uterine bleeding. STUDY DESIGN: One hundred eighty-one patients affected by menometrorrhagia and unresponsive to medical treatment agreed to be randomized to either laparoscopic supracervical hysterectomy or hysteroscopic endometrial ablation. They were monitored for 2 years to evaluate perioperative and postoperative outcomes, resolution of symptoms, and patient satisfaction. RESULTS: Duration of hospitalization, period of convalescence, perioperative complications, and resumption of normal activity were similar between the two groups. Operative time was significantly shorter in the hysteroscopic group, but patient satisfaction was significantly higher in the laparoscopic group. CONCLUSION: For the treatment of menorrhagia, hysterectomy has the distinct advantage of being curative but the disadvantage of being more invasive than the hysteroscopic approach. However, laparoscopic supracervical hysterectomy preserves the curative effect of hysterectomy without its increased surgical invasiveness, as suggested by the current study. (Am J Obstet Gynecol 2003;188:7-12.)
Key words: Endometrial ablation, hysteroscopy, laparoscopy, menorrhagia, supracervical hysterectomy
Abnormal uterine bleeding and menorrhagia are common gynecologic complaints that frequently lead to hysterectomy,1 the most common major surgical procedure among women of reproductive age.2 To reduce perioperative morbidity and patient discomfort, several minimally invasive surgical procedures have been recently introduced, ranging from various types of laparoscopic hysterectomies to different techniques of endometrial destruction by hysteroscopy. Five controlled randomized trials (RCT)3-7 compared hysterectomy and endometrial resection, and all concluded that hysteroscopic surgery is From the Department of Obstetrics and Gynecology, University of Rome “Tor Vergata,”a the Department of Gynecologic and Pediatric Sciences, University of Catanzaro,b the Endogyn Service, Private Endoscopic Associates,c the Center for Endocrinology and Reproductive Medicine,d and the Department of Obstetrics and Gynecology, University of Naples “Federico II.”e Received for publication January 24, 2002; revised March 28, 2002; accepted July 2, 2002. Reprint requests: Marco Sbracia, MD, Center for Endocrinology and Reproductive Medicine, Via Carlo Porta 10, 00153, Rome, Italy. E-mail:
[email protected] © 2003, Mosby, Inc. All rights reserved. 0002-9378/2003 $30.00 + 0 doi:10.1067/mob.2003.60
associated with lower postoperative morbidity, faster return to normal activities, and a significant cost advantage, but a much higher failure rate, with a reoperation rate of 22%.8 Hysterectomy, however, has been reported to be more effective in relieving menstrual symptoms and has a higher patient satisfaction rate but is significantly more invasive, whether it is performed by the abdominal or the vaginal route.9 Introduced by Semm in the late 1980s, laparoscopic supracervical hysterectomy (LSH) was designed with the purpose of being the least invasive, least traumatic, and the quickest way to remove the uterus. Because LSH is usually associated with lower risk of injury to the ureter or bladder and without adverse effects to either vaginal support or sexual function, it is considered less invasive. For these reasons, we designed this prospective, randomized study comparing LSH and hysteroscopic endometrial resection (HER) for perioperative outcome and cure rates, as well as patient satisfaction, using a validated questionnaire on the quality of life. Material and methods The study was conducted at Tor Vergata University of Rome and approved by the Ethics Committee and the In7
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Table I. Demographics of the patients treated with endometrial resection (HER) or supracervical laparoscopic hysterectomy (LSH) Characteristics
HER
No. of patients 89 Age (y) 43.2 ± 3.5 BMI 35.6 ± 1.4 Parity 1.8 ± 1.0 Uterine dimensions (cm3) 315 ± 43 Preoperative hemoblogin 9.9 ± 0.8 Symptoms pattern (No. [%]) Irregular periods 56 (62.9) Length of period >7 d 71 (79.7) Cycle 1000 mL) Cervical tear Conversion to LSH Conversion to abdominal surgery Blood transfusion
HER (n = 89)
LSH (n = 92)
41.7 ± 19.2* 89 ± 42
71.5 ± 28.1 97 ± 56
— —
13 3
4 5 1 2 1 0
5 — — — 2 2*
P < .01 NS
NS NS NS NS NS NS
NS, Not statistically significant. *Because of postsurgery bleeding in case of complications.
Table III. Postoperative course of patients treated with HER or LSH
Discharge time (d) Complications Fever Hematoma Urinary infection Hemoglobin at discharge Postoperative pain (VAS) at discharge At 3 d At 7 d Vaginal bleeding (d) Normal domestic activities (d) Return to work (d) Resumption of sexual activity (wk)
HER (n = 89)
LSH (n = 92)
1.3 ± 1.1
1.6 ± 1.5
NS
2 0 1 9.1 ± 1.2 3.8 ± 0.6 0.7 ± 0.6 0 7.6 ± 3.0 8.8 ± 4.3 3.2 ± 1.1 3.0 ± 0.9
3 2 1 8.8 ± 1.4 6.3 ± 1.9 0.9 ± 0.8 0 6.8 ± 3.1 10.3 ± 6.5 3.5 ± 1.4 3.2 ± 1.3
NS NS NS NS P < .01 NS NS NS NS NS NS
NS, Not statistically significant.
agreed to return home. At discharge, pain and hemoglobin were reevaluated and patients were asked to record their pain for 1 week. They were also asked to record the duration of vaginal bleeding, and the date when they resumed work, normal activities, and sexual intercourse. No particular instruction was given to patients to resume their normal activity. The follow-up visits were at 3 months and 1 and 2 years, when patients were checked for hemoglobin levels and queried about pain and bleeding patterns. The patients completed the SF-36 on quality-of-life issues, administered by a nurse blinded to the assigned treatment, before treatment and after 1 year of follow-up. No specific assessment for premenstrual syndrome or pelvic pain was done. The power analysis (1 – b) was based on a difference of 50% in satisfaction rate between patients treated with LSH or HER, in groups of 90 women each was more than 0.80 for 0.05 significance level. The statistical analysis was performed with the use of a commercial software program STATISTICA for Windows (Statsoft, Inc, Tulsa, Okla). Differences in age, parity, and body mass index (BMI) between groups were compared with the use of the
two-tailed Student t test for unpaired data. Preoperative basal values were compared with the postoperative values in each group with a Student t test for paired data. Postoperative complications were compared using the χ2 test. A repeated measures analysis of variance (ANOVA) was performed to detect differences in the postoperative pain score and satisfaction profile between the two groups. Operative time differences, estimated blood loss, duration of symptoms, and mean discharge time were compared with the use of the Wilcoxon rank sum test. P < .05 was defined as statistically significant. Results Two hundred three eligible patients gave written consent to the trial, but nine women (five assigned to HER and four to LSH group) withdrew before knowing the random assignment, and 13 refused the allocated treatment (eight in HER group and five in the LSH group). The final number of patients included in the study was 181, 89 treated by HER (group 1) and 92 by LSH (group 2). The two groups were similar in terms of age, parity, BMI, uterine dimensions, preoperative hemoglobin, patterns, and duration of symptoms (Table I). The patients
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Table IV. The follow-up results at 3 months, 1 and 2 years 3 mo
Hemoglobin levels Pain Bleeding Further surgical needs
1y
2y
HER
LSH
HER
LSH
HER
LSH
11.9 ± 2.2 3 0 1
12.1 ± 2.0 1 0 0
12.6 ± 2.5 5 3 5
13.0 ± 2.4 0 0 0
12.2 ± 2.3 9 11 12
13.5 ± 2.0 2 0* 1*
*P < .01.
Table V. Differences in patients’ quality of life assessed by SF-36 before and after surgery HER
General health* Physical function Role (physical) Role (emotional)† Mental health Social function‡ Vitality§ Pain
LSH
Pre (A)
Post (B)
Pre (C)
Post (D)
51.9 ± 12.7 62.6 ± 14.4 58.3 ± 13.0 60.8 ± 12.0 58.1 ± 12.3 56.4 ± 11.0 56.7 ± 11.0 57.1 ± 19.2
59.6 ± 13.7 66.4 ± 15.1 61.3 ± 14.8 64.2 ± 14.4 60.5 ± 14.8 67.3 ± 12.7 61.0 ± 12.8 58.6 ± 17.0
52.1 ± 12.1 62.8 ± 10.9 59.2 ± 15.4 60.3 ± 11.9 59.8 ± 12.9 53.6 ± 9.7 55.4 ± 10.3 56.4 ± 18.5
69.4 ± 14.2 67.6 ± 13.2 62.1 ± 13.9 68.1 ± 15.2 63.2 ± 13.6 88.5 ± 11.5 72.3 ± 11.3 60.1 ± 14.0
*AvsB, CvsD, BvsD, P < .01. †CvsD, P < .01. ‡AvsB, CvsD, BvsD, P < .01. §CvsD, BvsD, P < .01.
who failed randomization did not show differences in demographic characteristics with respect to the study group. All patients refusing randomization did so because they preferred to choose their own. Perioperative data are reported in Table II. The operative time was significantly lower in the HER group (41.7 ± 19.2 minutes) than in the LSH group (71.5 ± 28.1 minutes, P < .01). Blood loss and intraoperative complications were not different between the two groups. Two patients were transfused after postsurgery complications. Three patients undergoing HER were converted to LSH or abdominal surgery for extensive myomatosis, and two patients undergoing LSH were converted to abdominal surgery for extensive pelvic adhesion. Table III summarizes the postoperative course in both groups. Discharge time and postoperative complications were not significantly different between the two groups. Immediately after surgery and at the time of discharge, the pain was significantly higher in the hysterectomy group in comparison with the HER group (P < .01). Follow-up of patients is reported in Table IV. A higher reoperation rate and bleeding recurrence were observed in the HER group in comparison with the LSH group (P < .01). Table V reports quality of life scores in both groups of patients, before and after surgery. There was an improvement after surgery, regardless of the treatment group, for all parameters, but only the parameters of General
Health and Social Function reached statistical significance (P < .01) for both treatment groups and only for the LSH group in the case of Emotional Role and Vitality (P < .01). However, LSH patients showed statistically significant differences with respect to HER women for the following parameters: General Health, Social Function, and Vitality (P < .01). Comment Five previous trials,3-7 comparing traditional hysterectomy (abdominal or vaginal) with HER, concluded that hysteroscopic surgery is associated with lower postoperative morbidity, faster recovery to normal activities, and a significant cost advantage, whereas hysterectomy is more effective in the relief of menstrual symptoms, has a greater satisfaction rate, and is associated with a dramatically lower reoperation rate. This trial was designed to evaluate if the advantages reported with HER are still realistic when compared with LSH, which allows the fastest recovery of the patient; it is also the first trial comparing these two techniques. The perioperative course was similar for the two surgical groups in all aspects, except for the duration of surgery, which was significantly longer for the LSH than the HER group (71.5 ± 28.1 min vs 41.7 ± 19.2 min). However, compared with total abdominal hysterectomy or vaginal hysterectomy, as previously reported,3-7 LSH is associated with shorter duration, less blood loss, and fewer
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complications, supporting the hypothesis that LSH is less invasive than the more traditional abdominal or vaginal hysterectomies. The minimal surgical invasiveness of LSH is further supported by the postoperative course that was similar to that of the patients treated by HER in all aspects except for the early postoperative pain scores, which were slightly greater for the LSH group during the first postoperative day. However, by the third postoperative day, the degree of pain was similar between the two treatment groups. Similarly, the recovery time after surgery, measured by the temporal interval between surgery and resumption of domestic activity, sexual activity, and employment, was slightly longer for the LSH group but only for domestic activities. For resumption of sexual activity and employment, the recovery time was the same for the two groups, reaffirming the minimally invasive nature of laparoscopic supracervical hysterectomy, comparable to hysteroscopic surgery and much less life-disruptive than either abdominal or vaginal hysterectomy.15,16 In fact, Pinion et al3 reported that after abdominal hysterectomy, only 11% of patients resumed normal sexual activity versus 68% after hysteroscopic endometrial resection by 4 weeks. Furthermore, in our patients, the duration of vaginal bleeding after surgery was significantly longer for the HER than the LSH group. In a study evaluating the relative cost of transcervical endometrial resection versus abdominal hysterectomy for the treatment of menorrhagia, Schulpher et al17 reported that the hysteroscopic approach was associated with significant lower costs for the initial treatment. However, they did not assess the long-term cost associated with the repeated treatments, which is frequently the case where hysterescopic endometrial ablation failed, as reported by the Aberdeen Group.18 In this study, the authors reported that 38% of patients were re-treated during the 4-year follow-up time; this further reduced the relative cost difference between the HER and the hysterectomy groups. In our study, there was no significant difference in cost between HER and LSH treatment (data not shown). Consequently, any cost associated with re-treatment in the less definitive surgery of HER women would significantly exceed the cost associated with LSH. The parameters of quality of life improved after both surgical procedures, even though only two parameters, General Health and Social Function in both groups, and Role Emotional and Vitality in the LSH group, reached the statistical significance. However, the data showed that overall patient satisfaction was significantly better with LSH. The differences in SF-36 scores observed among patients treated with HER and LSH, especially regarding General Health, Social Function, and Vitality, highlight the effectiveness of LSH in solving patient problems. This treatment in active women permanently resolves the bleeding, pain, and urinary problems, with a faster recovery and sensible reduction in hospitalization and compli-
cations. The SF-36 is used in the routine assessment of patient satisfaction for several treatments and diseases worldwide.10-14 The main outcome was to measure the satisfaction profile of the patients, which for the vast majority of patients with menorrhagia, was the definitive eradication of the bleeding, best achieved with hysterectomy.15 Our data clearly show that the satisfaction profile at the 2-year follow-up is significantly higher after LSH than after HER, which is in agreement with all previous RCTs but the O’Connor study,6 which did not find statistical significant differences in patient satisfaction between the two treatments. This study showed the satisfaction rate in the hysteroscopic group was not significantly different from the hysterectomy group. In conclusion, as underlined by Lethaby et al8 in a Cochrane Review, all the major advantages of hysterectomy over endometrial destruction are substantiated in our trial: definitive improvement of symptoms and a better patient satisfaction profile. The previously reported advantages of hysteroscopic endometrial resection,4-7 shorter hospitalization and recovery time, or lower complication rates were not verified in our trial, suggesting that LSH is less invasive and less traumatic than the more traditional approaches, abdominal or vaginal hysterectomy. Furthermore, there was no total cost difference within a 2-year follow-up between the two treatments. These observations showed that LSH may be considered the best therapeutic choice for the management of abnormal uterine bleeding that is unresponsive to medical treatment, whereas hysteroscopic endometrial resection, with its associated incomplete resolution of bleeding problems, may be considered a less desirable surgical option.19
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