OBJECTIVE: To report the 4-year follow-up quality-of-life data of a randomized controlled trial between abdominal and laparoscopic hysterectomy and to investigate whether any difference in quality of life would remain long-term.
METHODS: Patients scheduled for hysterectomy for benign indications were randomized and received the Dutch version of the Short Form 36 questionnaire. The Short Form 36 consists of eight domains in which 100 points can be obtained. Higher scores denote a higher quality of life. A linear mixed model was used to study the differences between the two groups up to 4 years after surgery for each of the domains and the total Short Form 36 score separately.
RESULTS: Fifty-nine patients were randomized (27 to laparoscopic hysterectomy and 32 to abdominal hysterectomy). Median follow-up after surgery was 243 weeks (range, 188–303 weeks). The overall response rate on the Short Form 36 questionnaire after 4 years was 83% (49 of 59 patients). Total Short Form 36 questionnaire scores were significantly higher in patients after laparoscopic compared with abdominal hysterectomy up to 4 years after surgery (overall mean difference 50.4 points [95% confidence interval 1.0–99.7] in favor of laparoscopic hysterectomy). Higher scores were also found on the domains physical role functioning, social role functioning, and vitality.
CONCLUSION: With a follow-up of 4 years, patients who underwent laparoscopic hysterectomy reported a better quality of life compared with abdominal hysterectomy. Therefore, patients in whom vaginal hysterectomy is not possible should be able to have a laparoscopic hysterectomy, if feasible, in terms of uterine size.
CLINICAL TRIAL REGISTRATION: ISRCTN Register, www.controlled-trials.com/isrctn, ISRCTN15214439.
LEVEL OF EVIDENCE: I
Laparoscopic hysterectomy results in better long-term quality of life compared with abdominal hysterectomy.
From the Departments of Obstetrics and Gynecology and Epidemiology and Biostatistics, Radboud University Nijmegen Medical Centre, Nijmegen, and the Department of Obstetrics and Gynecology, Máxima Medical Centre Veldhoven, Veldhoven, The Netherlands.
The authors thank Dr F. ten Cate for her valuable contributions in collecting the Short Form 36 questionnaires.
Presented in part at the National Congress for Gynecologists, November 11–12, 2010, Arnhem, The Netherlands.
Corresponding author: Theodoor E. Nieboer, MD, 791, Department of Obstetrics and Gynecology, PO Box 9101, 6500 HB Nijmegen, The Netherlands; e-mail: email@example.com.
Financial Disclosure Dr. Vierhout is a member of the OAB faculty of Astellas. The other authors did not report any potential conflicts of interest.
In studies reporting on surgical procedures, emphasis often lies on outcome measures such as operation time, surgical complications, hospital stay, and recurrence rate. From the patient's point of view, however, results such as symptom resolution, return to normal activities, and patient satisfaction are at least as important as the classical outcomes.1 These patient-centered outcomes may well be summarized in the measurement of quality of life with validated questionnaires. Especially in surgery for benign diseases, quality of life may be one of the most important outcome measures and should be used more systematically in trials,2 because it is now only reported in up to 5% of randomized trials.3 In cancer studies, the importance of patient-centered outcomes are likewise emphasized4 and reported.5,6
More than 500,000 hysterectomies for benign pelvic diseases are performed in the United States each year.7 Despite this high number of hysterectomies, a small minority of studies on hysterectomy have evaluated quality of life after different types of surgical approaches.8–16 A recent review and meta-analysis of randomized trials reported that, compared with abdominal hysterectomy, women who received laparoscopic hysterectomy had a lower intraoperative blood loss, lower drop in hemoglobin, lower percentage of wound infections, and quicker return to normal activities but a higher rate of urinary tract injuries.17 A large observational study from Finland has shown that the risk of urinary tract injuries in laparoscopic hysterectomy decreases with surgical experience.18 Only two studies reported quality of life as a primary outcome measure,8,11 whereas an additional seven mentioned quality of life as a secondary outcome measure.9,10,12–16 Conclusions from two of these studies were that, up to 12 weeks postoperatively, quality of life was higher after laparoscopic hysterectomy as compared with abdominal hysterectomy. However, because the longest follow-up was 1 year, no conclusions could be drawn on any long-term effect.
In the present study, we report the long-term follow-up (4 years) from a randomized controlled trial between laparoscopic and abdominal hysterectomy for benign gynecologic disease.11 The goal of this study was to investigate whether any difference in quality of life would remain a long time after surgery.
MATERIALS AND METHODS
Between August 2002 and January 2005, patients scheduled for hysterectomy for a benign condition, in whom vaginal hysterectomy was not possible, were randomized between laparoscopic and abdominal hysterectomy. Exclusion criteria were size of the uterus greater than 18 weeks of gestation, a suspicion of malignancy, a previous lower midline incision, the need for simultaneous interventions like prolapse repair, and inability to speak Dutch. Furthermore, patients using antidepressant drugs or with a history of psychiatric disease or other severe medical issues were excluded. Randomization took place by opening numbered, sealed opaque envelopes. For concealment, an independent person had randomly assigned an equal number of 38 papers with either intervention to the envelopes. Closed envelopes were randomly drawn at each new inclusion. Neither the patients nor the medical team were blinded to the intervention.
The study was conducted in the Máxima Medical Centre, a large teaching hospital in the south of The Netherlands. The gynecology department is experienced in minimal access surgery and the first laparoscopic hysterectomy was performed in 1992. Laparoscopic hysterectomies were all intentionally total laparoscopic hysterectomies and abdominal hysterectomy was performed by the standard extrafascial technique. Laparoscopic hysterectomies were performed by three experienced gynecologists. There was a standard operative procedure, which has been described in detail before.11 Approval from the local medical ethical committee (METC-MMC) was acquired and informed consent from each participant was obtained.
Short-term quality of life was the primary outcome measure of the trial and these results have been published before.11 After a median follow-up of 4 years, the participants from the primary study were sent the Dutch version of the Short Form 36 questionnaire (similarly as used in the first study) by regular mail. The Short Form 36 is a general health-based survey of quality of life. It has been validated, is used widely across medical disciplines, and can be self-administered by the patient with reliability.2,19 The Short Form 36 consists of eight domains (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health) and on each domain, 100 points can be obtained. As a consequence, the total Short Form 36 score may range from 0 to 800 points. Higher scores denote a better quality of life. In a previous study, the Short Form 36 has been identified as the superior questionnaire to assess quality of life after hysterectomy.20 Furthermore, the patients were asked if any adverse health event had occurred since last follow-up.
Sample size was calculated for quality of life as measured by the Medical Outcome Trust 36-Item Short Form Health Survey questionnaire. A difference of 15 points per scale was considered clinically relevant.8 With a standard deviation of 20, a type I error of 0.05, and 80% power, 28 patients were needed per arm. A linear mixed model was used to study the differences between the two groups up to 4 years after surgery while accounting for the baseline values for each of the domains and for the total Short Form 36 score separately. The dependent variable was a Short Form 36 (domain) score. The independent continuous variable was the baseline value of the dependent variable. The independent class variables were group (laparoscopic and abdominal hysterectomy) and weeks postsurgery (2, 4, 6, 12, and 212). The interaction term between these two variables was also included in the model. The intercept of each patient was treated as random variable in the model. This technique allows us to estimate differences between treatments given the baseline value, whereas differences in recovery among patients are allowed.
Initially, the actual time at the last follow-up and the interaction term with group were included in the model to study the effect of the variation in time of the last follow-up (range, 3.6–5.8 years) on the outcome. However, these terms were omitted from the final model, because these never reached the level of statistical significance. The estimated regression parameters with standard errors of the final model of the Short Form 36 (domain) score were used to calculate the average level with (confidence interval [CI]) per week of the patients in each group. These levels with CI bands are further presented in figures. The data were analyzed using SAS 9.2 and SPSS 16.0. P<.05 was considered statistically significant.
Fifty-nine patients were randomized (27 to laparoscopic and 32 to abdominal hysterectomy).11 After 4 years, 49 patients (83%) returned the Short Form 36 questionnaire. Median follow-up after surgery was 243 weeks (range, 188–303 weeks). Patient and surgical characteristics at baseline are summarized in Table 1. These results are consistent with the short-term outcomes, except for the observed difference in uterine weight.
Table 2 shows the estimated mean difference of the Short Form 36 domains postsurgery between the laparoscopic hysterectomy group and the abdominal hysterectomy group using a linear mixed model. The second column of Table 2 shows that on average the total Short Form 36 score, after correction for baseline values, was statistically significant higher in the laparoscopic hysterectomy group compared with the abdominal hysterectomy group up to 4 years (ie, 212 weeks) postsurgery. In other words, the mean total Short Form 36 score was estimated to be 50.4 points (95% CI 1.0–99.7) higher in the laparoscopic hysterectomy group at each point of measurement up to 4 years postsurgery in case the mean values presurgery would have been identical. Similarly, higher scores for laparoscopic hysterectomy were also found on the domains vitality (12.8, 95% CI 5.9–19.8), physical functioning (8.5, 95% CI 0.6–16.4), and social functioning (8.4, 95% CI 0.7–16.2). Regarding the domains general health, physical role functioning, emotional role functioning, social functioning, and mental health, the differences between the two groups never reached the level of statistical significance. Note that the 95% CI of the adjusted overall mean difference between the groups of these domains included (easily) the value zero (ie, no difference).
Figures 1 and 2 visualize the agreement of the observed data with the estimated mean profiles in both groups. Specifically, the observed means of the total Short Form 36 score and the domains vitality, physical functioning, and social functioning are in agreement with the estimated means using a model of equal differences at each point of measurement up to 4 years postsurgery (ie, the parallel-line model).
Table 2 shows that regarding the bodily pain, on average, the score in the laparoscopic hysterectomy group was statistically significantly higher compared with the abdominal hysterectomy group in the early weeks postsurgery. However, this difference was found to be not statistically significant at 12 weeks and 212 weeks (ie, 4 years) postsurgery. Figure 2 also visualizes the agreement of the observed data and the nonparallel-line model of bodily pain postsurgery.
Note that the differences between both groups in Figures 1 and 2 are larger compared with the estimated differences in Table 2, because Table 2 shows the estimated differences adjusted for the baseline values. In other words, Table 2 shows the difference one may expect given equal baseline values.
One patient (laparoscopic hysterectomy) reported loss of sensation during intercourse, which she attributed to the removal of her cervix. Besides this case, no specific surgery-related long-term complications were reported. One patient (abdominal hysterectomy) had developed rheumatism in the upper extremities, one patient (laparoscopic hysterectomy) had developed fibromyalgia, one patient (abdominal hysterectomy) was treated for pulmonary carcinoma, and one patient (abdominal hysterectomy) had cardiac problems (not otherwise specified).
In this study, quality-of-life data at 4 years follow-up in a randomized controlled trial between laparoscopic and abdominal are presented. It was observed that 4 years after surgery, laparoscopic hysterectomy still offers advantages over abdominal hysterectomy in terms of quality of life as measured with the Short Form 36 questionnaire.
The finding that quality of life is still better 4 years after laparoscopic hysterectomy is striking. The benefits of avoiding laparotomy seem to work through after several years. Until now, laparoscopic hysterectomy has only proven to result in better quality of life until 610 and 1211 weeks after surgery. There are several possible explanations for the long-term effect on quality of life. The ongoing advantages of laparoscopic hysterectomy may be related to the higher scores on the Body Image Scale, as observed by Garry et al.10 Patients undergoing laparoscopic hysterectomy may be influenced positively by the fact that they underwent what in layman press is known as the “minimally invasive method” (eg, www.hysterectomyoptions.com). Chronic abdominal pain may also contribute to less quality of life. In their review of chronic pain after surgery, Perkins et al state that chronic abdominal pain is common after cholecystectomy (range, 3%–56%).21 Nerve injury as well as psychological vulnerability and anxiety were mentioned as risk factors for developing chronic pain. In a prospective cohort study of patients having gastrointestinal surgery, Bruce et al reported that 4 years after laparotomy, the prevalence of chronic pain was 18%.22 In their cohort, risk factors for chronic postsurgical pain included female gender, younger age, and surgery for benign disease. This resembles the characteristics of patients having hysterectomy for benign gynecological disease as described in our study. Crombie et al described their experience with patients attending specialist chronic pain clinics.23 In their survey among 5,130 patients with chronic pain, 22.5% implicated surgery as the cause of their pain and was particularly associated with the development of abdominal pain. Furthermore, there is evidence that formation of peritoneal adhesions may play a role in the development and persistence of chronic abdominal complaints.24,25
The fact that laparoscopy is superior to laparotomy in terms of hospital stay, pain, and convalescence has been proven for inflammatory bowel disease,24,26,27 pancreatic surgery,28 cholecystectomy,29 appendectomy,30,31 inguinal hernia repair,32 benign ovarian tumor33 and hysterectomy.17 However, searching for randomized trials with quality of life as the outcome measure only revealed superiority of laparoscopy in acute appendicitis30 and hysterectomy.11 In the era of enhancing patient-centeredness, quality of life may well be the superior outcome measure comprising elements of surgery that patients find most important. As such, quality of life should be studied more often, especially in studies for benign indications.
The superiority of laparoscopic hysterectomy in terms of quality of life was consistent with better secondary outcomes such as hospital stay, use of analgesics, and convalescence.11 Contoupoulos et al performed a systematic review on reporting and interpretation of Short Form 36 outcomes in randomized trials published in 2005 in 22 journals with a high impact factor.2 Over 1,000 papers were screened of which 52 were identified as randomized trials using Short Form 36. They concluded that although Short Form 36 measurements sometimes produce different results from those of the primary efficacy outcomes, it rarely modifies the overall interpretation of randomized trials. Our findings are consistent with this.
This study has some limitations. First, there is a small sample size and not all patients returned the questionnaires after 4 years. However, a response rate of 83% after 4 years is still acceptable. Like in the initial study, a sample size calculation was performed to detect a difference of 15 points per scale of the Short Form 36.11 In this way, 28 patients were needed per arm. Although the current number of participants failed to reach the acquired 56 patients, we still observed significant differences in the total Short Form 36 score and in three of eight domains. Furthermore, note that at baseline, there were some significant differences in quality of life data. These might be the result of the fact that patients completed the questionnaire after randomization. Corrections for this difference have, however, been made in the linear mixed model. Concerning the somewhat skewed diversion of patients in the laparoscopic and abdominal hysterectomy groups, this is probably the result of the exclusion of patients who appeared to have endometrial carcinoma and who were analyzed separately. With regard to the length of hospital stay, discharge did not occur on predefined criteria and, as a consequence, hospital stay in patients undergoing laparoscopic hysterectomy was longer compared with some other studies on this subject. Another limitation was the matter of patients self-reporting their newly diagnosed conditions. Consequently, no certainty on International Classification of Diseases diagnosis could be acquired. Other nonsurgical factors that may have influenced quality of life, eg, death of a spouse, have not been taken into account. As a consequence, these matters may have been a possible cofounder. Finally, in our study, laparoscopic procedures were all intentionally total laparoscopic hysterectomies. It is therefore debatable to extrapolate these findings to laparoscopic-assisted vaginal hysterectomy.
In conclusion, it was observed that with a follow-up of 4 years, patients who underwent laparoscopic hysterectomy reported better quality of life compared with patients undergoing abdominal hysterectomy. Therefore, all patients listed for hysterectomy in whom vaginal hysterectomy is not possible and with a moderately enlarged uterus should be able to opt for laparoscopic hysterectomy.
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© 2012 The American College of Obstetricians and Gynecologists
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