Psychological wellbeing after laparoscopic and abdominal hysterectomy—a randomised controlled multicentre study

Authors


Dr P Persson, Department of Obstetrics and Gynaecology, University Hospital, 751 85 Uppsala, Sweden. Email par.persson@akademiska.se

Abstract

Objective  To compare laparoscopic hysterectomy and abdominal total hysterectomy regarding influence on postoperative psychological wellbeing and surgical measures.

Design  A prospective, open, randomised multicentre trial.

Setting  Five hospitals in the South East of Sweden.

Population  Hundred and twenty-five women scheduled for hysterectomy for benign conditions were enrolled in the study, and 119 women completed the study. Fifty-six women were randomised to abdominal hysterectomy and 63 to laparoscopic hysterectomy.

Methods  Psychometric tests measuring general wellbeing, depression and anxiety preoperatively and 5 weeks and 6 months postoperatively.

Main outcome measures  Effects of operating method on the psychological wellbeing postoperatively. Analysis of data regarding operating time, peroperative and postoperative complications, blood loss, hospital stay and recovery time.

Results  No significant differences in the scores were observed between the two groups in any of the four psychometric tests. Both the surgical methods were associated with a significantly higher degree of psychological wellbeing 5 weeks postoperatively compared with preoperatively. The operating time was significantly longer for the laparoscopic hysterectomy group, but the duration of the stay in hospital and sick-leave were significantly shorter for laparoscopic hysterectomy group compared with the abdominal hysterectomy group.

Conclusions  General psychological wellbeing is equal after laparoscopic and abdominal hysterectomy within 6 months after the operation. The advantages of the laparoscopic hysterectomy are the shorter stay in hospital and shorter sick-leave, but these issues must be balanced by a longer duration of the operation.

Introduction

Hysterectomy is the most common major gynaecological operation. It is most often performed for benign conditions such as bleeding disorders or uterine fibroids and as such is performed in order to improve women’s quality of life. Traditionally, hysterectomy is performed through a laparotomy. Laparoscopic hysterectomy was introduced in 19891 and was assumed to give substantial advantages for woman in terms of recovery time.

Several studies have compared safety and cost-effectiveness of laparoscopic and total abdominal hysterectomy with contradictory results.2–8 Conflicting results regarding the psychological outcomes of hysterectomy have been published, but most of the literature demonstrates that the majority of women show no adverse psychological outcomes after hysterectomy.9–15 However, the diverse design of these studies (retrospective or prospective, longitudinal but not randomised) makes the results difficult to interpret. It was thought that woman would recover sooner after laparoscopic compared with abdominal hysterectomy and that this benefit would include psychological benefits, but this has been poorly studied. One study of 74 women randomised to laparoscopic or abdominal hysterectomy found that the postoperative psychological wellbeing was not related to the mode of surgery.16 There are still very few randomised prospective studies which have focused on postoperative psychological states,16–18 which remains an important outcome in addition to feasibility and cost-effectiveness evaluations of new procedures.

The objective of this study was to assess, in a prospective randomised multicentre study, whether the psychological outcome differs between laparoscopic and abdominal hysterectomy. Our hypothesis was that laparoscopic hysterectomy would provide a more favourable psychological outcome than abdominal hysterectomy.

Methods

This was a randomised, prospective, open, controlled multicentre study of laparoscopic hysterectomy versus abdominal hysterectomy. The departments of Obstetrics and Gynaecology at five hospitals in the southeast Health Region of Sweden participated in the study. The hospitals were two county hospitals, two central hospitals and one university hospital.

Women admitted to the departments for hysterectomy due to benign gynaecological conditions between October 1996 and May 2003, in whom laparoscopic hysterectomy was considered to be possible, were eligible for the study. Only women who fluently spoke and understood the Swedish language were included in the study. The ethical principles of the study conformed to the Helsinki declaration.

Medical inclusion criteria were menometrorrhagia, dysmenorrhoea, dysplasia of the cervix, endometrial hyperplasia without atypia, fibroids or other benign gynaecological diseases. At least one ovary was to be preserved at the operation. Exclusion criteria were genital tract malignancy, preoperative treatment with gonadotrophin-releasing hormone analogues, postmenopausal women without hormone replacement therapy (HRT) and severe psychiatric disorders. Women with HRT were allowed to participate in the study if the HRT was continued until the last follow up 6 months postoperatively.

After written and verbal informed consent, the women were randomised to either abdominal or laparoscopic hysterectomy according to a random table. The randomisation was conducted as a bloc-randomisation with five blocs, one for each participating hospital. Each bloc contained 25 objects with approximately equal number of the two surgical methods. The surgical procedure was written on a label sealed in opaque envelopes that were numbered consecutively in accordance with the random table. The envelopes were opened in consecutive number order. The women were assigned to the treatment group approximately 1 week before the surgery and informed about their assignment before surgery. If the recruitment rate in a participating hospital was less than three women per year, the hospital was excluded from recruitment of further women into the study. The remaining sealed envelopes from that hospital were taken over by the university hospital for completion of the study.

Abdominal hysterectomies were performed or supervised by experienced gynaecological surgeons and laparoscopic hysterectomies were carried out by skilled gynaecological laparoscopists. All women received prophylactic antibiotics with a single dose of 1.5 g cefuroxime and 1 g metronidazole intravenously. In case of allergy to penicillin, each hospital used prophylactic antibiotics according to the local policy.

Abdominal hysterectomy was performed through a Pfannenstiel skin incision. The uterine cervix was dissected extrafascially. After removal of the uterus, the vaginal cuff was closed with a traditional front-to-back closure technique and the uterosacral ligaments were anchored with sutures to the vaginal cuff. Peritonealisation of the pelvic peritoneum was not performed. For laparoscopic hysterectomy, a three-port technique was used. Resection of the parametrium and uterine artery was performed either with bipolar coagulation or an endoscopic stapling devise. The remaining parts of the cardinal ligaments and the uterosacral ligaments were resected through the vaginal part of the operation. The specimen was removed through the vagina. The uterosacral ligaments were attached to the vaginal cuff, which was closed from the vagina with the front-to-back closure technique and no pelvic peritonealisation was carried out.

Demographic data including age, length, weight, parity, smoking habits and actual medication were registered preoperatively in a standardised protocol. Peroperative data included indication for surgery, date of surgery, operating time (from skin incision to final closure of the skin) and peroperative blood loss as estimated by the anaesthetist. Furthermore, data included information on the volume of intravenous infusions or blood transfusions given perioperatively, intra and postoperative complications and duration of hospital stay.

The woman was discharged from hospital when she was mobilised, had sufficient pain relief with oral analgesics and was voiding spontaneously with sufficient urinary bladder emptying. At discharge, the woman had a sick-leave of 14 days, which is a shorter time compared with the 28 days that we have used as standard time previously. The research nurse contacted the woman and asked about general wellbeing after approximately 10 days and then weekly until the woman had recovered. The sick-leave was prolonged by 1 week at a time if necessary, until the woman was able to return to work.

The woman visited the outpatient clinic at 5 weeks and 6 months postoperatively. During these visits, a clinical examination was carried out and data on postoperative complications, present medication and the actual duration of sick-leave were recorded.

Psychological measures

Psychological functioning was measured approximately 1 week preoperatively (baseline) and 5 weeks and 6 months postoperatively by psychometric measurements. The Psychological General Well-Being (PGWB) and the Women Health Questionnaire (WHQ) were used to assess general psychological wellbeing. They are both well-validated instruments for that purpose.19–22 Also, the Spielberger Trait Anxiety Inventory (STAI) and the Beck’s Depression Inventory (BDI) were used for measuring specific psychological functioning. The reasons for choosing the STAI and the BDI tests in the present study were to provide the possibility to detect changes in anxiety and depression modes.

The PGWB consists of 22 questions referring to anxiety, depression, wellbeing, self-control, health and vitality.19 Each question is rated on a 6-point scale ranging from 1 to 6. The sum score ranges from 22 to 132. The higher the sum score, the higher degree of wellbeing. The PGWB has been tested for validity against various validated mental health scales. Its Swedish version has also been validated.20

The WHQ is a questionnaire providing a detailed examination of minor psychological and somatic symptoms experienced by perimenopausal and postmenopausal women.21,22 It consists of 36 questions grouped in nine sections describing somatic symptoms, depressive mood, cognitive difficulties, anxiety, sexual function, vasomotor symptoms, sleep problems, menstrual symptoms and attraction. Each question is rated from 1 to 4 and the sum score ranges from 36 to 144. A higher sum score indicates more distress and dysfunction. The Swedish translation of the WHQ has been validated.23

STAI is a questionnaire that assesses anxiety in two different forms representing state and trait. In this study, the trait form is used. The trait form (Y-2) consists of 20 statements that evaluate how respondents feel ‘generally’.24 Individuals respond to each item on a 4-point Likert scale, indicating the frequency with which each strategy is used. The sum score ranges from 20 to 80, and the sum score increases in response to physical danger and psychological stress. The STAI has been widely used in assessing general anxiety in medical, surgical and psychiatric patients and has been translated to Swedish but not validated for Swedish circumstances.

The BDI is a quantitative self-report scale for measuring the presence and severity of depression in clinical and normal populations of adults and adolescents.25 It is made up of 21 items. Each item is rated on a 4-point scale (0–3) in increasing severity, adding up to a total score range from 0 to 63. A high sum score indicates a more depressive state. The BDI has been translated to but not validated for Swedish circumstances.

Ethics

The study was approved by the ethics research committee of the Faculty of Health Sciences, Linköping University.

Statistics

For the analyses of the descriptive and demographic data, Student’s t test was applied for continuous data. Yates-corrected χ2 and Fisher’s exact test were used for nominal data. Analysis of variance (ANOVA) for repeated measurements was used to compare the results of the psychological measurements between the two groups from baseline to 6-month follow up. Statistical significance was set at the 5% level.

The sample size was calculated with the assumption that an increase in PGWB sum score of 10 units was clinically relevant. In order to demonstrate that a difference was statistically significant in 90% of the women at a 5% level (two-sided testing), i.e. with a 90% power, 92 women were necessary. We estimated the drop-out rate to be 20%, thus approximately 120 women were needed in the study. All analyses were on an intention-to-treat basis.

Missing data in the questionnaire

Missing data were handled in the following way. If there was a missing answer to an item in a questionnaire, the missing score was substituted with the mean value of the rest of the scores in the questionnaire from the same women. The frequency of missing answers was 0.5% for all of the questionnaires.

Inclusion of participants in ANOVA for repeated measures requires individual data for every moment of measurement. If a questionnaire was not completed by one of the women on a single occasion, the mean value of that specific questionnaire for the group at the same occasion was used in order to reduce the drop-outs from the ANOVA analyses. In all, 16 questionnaires (four participants) were not complete (1.1%).

Results

The flow chart of women assessed for eligibility in the study and the included women is illustrated in Figure 1. There were 125 women enrolled and randomised in the study. Six women (five allocated to abdominal hysterectomy and one to laparoscopic hysterectomy) withdrew after informed consent prior to the operation or withdrew in the postoperative period before the 5-week follow up. The remaining 119 women completed the study. Eighteen women were recruited from the county hospitals, 29 from the central hospitals and 72 from the university hospital. Fifty-six women were randomised to abdominal hysterectomy and 63 to laparoscopic hysterectomy. There were no statistically significant differences between the two groups regarding the descriptive, clinical and demographic data (Table 1).

Figure 1.

Flow chart of the women in the study. The number of women assessed for eligibility corresponds to the total number of hysterectomies on benign indications performed in the participating hospitals during the study period. Hysterectomies carried out in association with operations for benign ovarian tumours or genital prolapse are not included. No systematic information was collected during the study course about the reason for why a woman was not enrolled in the study. In a retrospective review of the diagnosis of the 1235 women who were excluded, 711 (58%) had the primary diagnosis of uterine fibroids, indicating that in a substantial part of the excluded women, laparoscopic hysterectomy was not considered possible.

Table 1.  Descriptive, clinical and demographic data
 Abdominal hysterectomy, n= 56Laparoscopic hysterectomy, n= 63
  1. BMI, body mass index.

  2. Data are expressed as median (range) or number (%).

Age (years)44 (29–60)44 (32–62)
BMI (kg/m2)24.4 (18.4–33.5)24.0 (18.2–40.4)
Parity2 (0–5)2 (0–5)
Smokers16/55 (29)19/60 (32)
Indication for surgery
Meno/metrorrhagia44 (78.6)48 (76.2)
Endometriosis3 (5.4)2 (3.2)
Fibroids2 (3.6)2 (3.2)
Dysplasia of the cervix3 (5.4)3 (4.8)
Dysmenorrhoea3 (5.4)6 (9.5)
Endometrial hyperplasia0 (0)1 (1.6)
Others1 (1.8)1 (1.6)
HRT users
At baseline2 (3.6)3 (4.8)
At 5-week follow up3 (5.4)5 (7.9)
At 6-month follow up6 (10.7)6 (9.5)

The results of the psychological measures are presented in Table 2. No statistically significant differences in the sum scores were observed between the two groups for any of the four questionnaires. However, all measures showed a significant change over time, reflecting an improvement for psychological wellbeing in general and more specifically for anxiety and depression.

Table 2.  Questionnaire scores from women before and after abdominal total hysterectomy or laparoscopic hysterectomy
QuestionnaireTimingAbdominal hysterectomy, n= 56Laparoscopic hysterectomy, n= 63ANOVA
 Mean scoreMean scoreMain effect between groupsMain effect over timeInteraction
  1. Data are mean sum score (SD).

  2. PGWB score 22–132; high score indicates greater wellbeing.

  3. WHQ score 36–144; high score indicates greater distress/dysfunction.

  4. STAI score 20–80; high score indicates greater psychological stress.

  5. BDI score 0–63; high score indicates more depressed state.

PGWBBaseline96.5 (16.5)96.7 (17.9)P= 0.719P < 0.0001P= 0.772
 5 weeks102.1 (16.4)100.4 (16.7) 
 6 months106.1 (16.0)104.7 (18.5) 
WHQBaseline63.9 (18.2)64.9 (13.9)P= 0.800P < 0.0001P= 0.953
 5 weeks54.3 (17.1)54.6 (12.8) 
 6 months54.2 (17.2)55.0 (14.4) 
STAIBaseline34.7 (10.1)35.6 (9.1)P= 0.418P= 0.0002P= 0.762
 5 weeks31.7 (10.6)32.7 (8.7) 
 6 months31.7 (9.2)33.6 (10.2) 
BDIBaseline6.9 (6.1)6.6 (5.8)P= 0.788P= 0.0002P= 0.223
 5 weeks5.0 (6.5)4.6 (5.5) 
 6 months4.0 (5.2)5.3 (6.8) 

Data regarding surgery and the postoperative period including complications are shown in Table 3. The median operating time was significantly longer for laparoscopic hysterectomies compared with abdominal hysterectomies. The median duration of hospital stay and sick-leave was significantly longer in the abdominal hysterectomy group. Three women in the laparoscopic hysterectomy group were converted to laparotomy during surgery: one because of an injury of the urinary bladder, one due to technical surgical problems and the third due to massive adhesions in the pelvis. The operation and postoperative period was uncomplicated in 43 (77%) of the abdominal hysterectomy group and in 43 (68%) of the laparoscopic hysterectomy group (P > 0.05). Major complications comprising intra-abdominal bleeding exceeding 1000 ml, intra-abdominal infection or bladder injury and minor complications were infrequent and occurred equally in the two groups (Table 3).

Table 3.  Surgical and clinical data
 Abdominal hysterectomy, n= 56Laparoscopic hysterectomy, n= 63P value
  1. NS, not significant; UTI, lower urinary tract infection.

  2. Data are expressed as median and (range) or number (%).

  3. Other complications included lower limb fracture, pleuritis, urinary retention, urolithiasis, partial bowel obstruction.

  4. A woman may have had more than one complication.

Operating time (minutes)64 (35–150)99 (50–190)<0.0001
Blood loss (ml)175 (25–800)150 (50–1200)NS
Blood transfusion (no. of women)3 (5.4)2 (3.2)NS
Intravenous fluids per/postoperatively (l)4.0 (2.0–8.5)4.0 (2.0–8.0)NS
Uterine weight (g)130 (45–995)160 (49–350)NS
Duration of hospital stay (days)3.0 (2–7)2.0 (1–11)0.0006
Duration of sick-leave (days)33.5 (14–61)26.0 (3–86)0.0081
No complications reported43 (77)43 (68)NS
Complications (no. of women) 
Intra-abdominal bleeding exceeding 1000 ml1 (1.8)4 (6.3)NS
Intra-abdominal infection1 (1.8)1 (1.6)NS
Bladder injury0 (0)1 (1.6)NS
Vault haematoma3 (5.4)0 (0)NS
Incision haematoma1 (1.8)2 (3.2)NS
Wound infections or UTI2 (3.6)6 (9.5)NS
Pain3 (5.4)4 (6.3)NS
Fatigue2 (3.6)2 (3.2)NS
Others3 (5.4)2 (3.2)NS

Antidepressant medication was used by eight women at baseline, by three (5.4%) in the abdominal hysterectomy group and five (7.9%) in the laparoscopic hysterectomy group. At the 6-month follow up, three women, two in the laparoscopic hysterectomy group and one in the abdominal hysterectomy group, had stopped using antidepressants and one woman (in the laparoscopic hysterectomy group) had started medication.

Discussion

This study shows that postoperative psychological function did not differ significantly between women who had undergone an abdominal or laparoscopic hysterectomy. Shortly after its introduction, laparoscopic hysterectomy was thought to be superior to abdominal hysterectomy26–28 and to give advantages for woman in all outcome measures. Since then, several randomised studies have tested different aspects of the techniques against each other but little emphasis has been placed on postoperative psychological wellbeing. Our data demonstrated that laparoscopic hysterectomy was not superior to abdominal hysterectomy in terms of psychological wellbeing.

Hysterectomy in general is associated with an increase of women’s overall health-related quality of life but the aspects of depression and anxiety have been debated. Regarding depression, different definitions of depressive state have been used in the literature, but the prevalence of depression among women who undergo hysterectomy has declined during the recent decades.29 A significant improvement of preoperative depression and anxiety has been shown in several studies after hysterectomy.9,12,13,17 However, preoperative psychopathology has been shown to be predictive of postoperative psychopathology.30 Some earlier studies have shown a rather high prevalence of depression in women who were scheduled for hysterectomy.31,32 We excluded women with obvious severe psychiatric disorders, and at baseline, no woman met the BDI criteria for a severe depressive state with a score above 28.33 Nevertheless, we found a significant decline of the mean BDI score after the hysterectomy, indicating a reduction in the prevalence of depressive mood. It must be kept in mind that this might not be of any clinical importance since the score of most of the women before and after the hysterectomy were within the limits of normality. The prevalence of women with antidepressant or mood-enhancing medication was low in our study and did not change significantly between the time of operation and the 6-month follow up. Thus, the improvement in BDI and STAI scores do not seem to be caused by medication.

In studies regarding laparoscopic and abdominal hysterectomy, only a few deal with psychological outcome. In a previous randomised study, also from Sweden and using PGWB, no difference between abdominal and laparoscopic hysterectomy were found.16 A large multicentre study, which used quality of life as a secondary outcome measurement assessed by a brief questionnaire, also failed to show a difference between abdominal and laparoscopic hysterectomy.8 Our study showed a similar result. In both these studies,8,16 the samples comprised women after hysterectomy with or without bilateral oophorectomy. This makes the results more difficult to interpret since the changes in estrogen levels may influence the psychological wellbeing.34 Besides, the use of HRT in the study by Garry et al.8 was not specified preoperatively or postoperatively. In our study, the use of HRT is specified and at least one ovary was preserved in order to retain the ovarian function postoperatively. In that way, we intended to avoid a surgical menopause that could interfere with the psychological functioning. We included only a few postmenopausal women who had to comply with the inclusion criteria concerning HRT that was kept during the study period.

Several life events unrelated to the hysterectomy can occur in a woman’s life during 6 months that could influence her psychological health. The lack of information of major life events during the study period might influence the interpretation of the results of the study. None of the previously mentioned studies was controlled for major life events. We did not specifically include a test for detecting other major life events, but in the follow up at 6 months, the women were asked for new problems which had occurred during the follow-up period or if new medications or other medical treatments were instituted. Thus, we believe that other possible major life events play a very little role in the results of our study. The preoperative measurement of the psychological wellbeing was carried out 1 week before surgery. It might be assumed that the women at that time were more distressed by the imminent operation than in general. However, the result of the randomisation, i.e. the allocated method of hysterectomy, did not seem to influence the psychological function differently in the two groups. In both the groups, significant psychological improvements according to the measures were found at the 5-week follow up compared with the baseline assessment. This is consistent with other studies concerning abdominal hysterectomy.35 The improvements found at the 5-week follow up were either preserved or increased by the 6-month assessment.

The operation time was significantly longer for laparoscopic hysterectomy, but the time in hospital and the sick-leave was significantly shorter than after abdominal hysterectomy. These findings are in accordance with several studies in the meta-analysis by Johnson et al.36 A short hospital stay and the need of a short sick-leave might be assumed to be of benefit to woman in terms of psychological wellbeing, but these issues did not obviously influence the psychological wellbeing at follow up. It is interesting that the median duration of sick-leave for the abdominal hysterectomy group in our study is shorter than that for the laparoscopic group in the ‘eVALuate’ study.8 The women in our study decided themselves when to return to work, whereas in the ‘eVALuate’ study the surgeon’s practice standardised the advice concerning resumption of normal activities including work.

Conclusions

In benign gynaecological disorders, laparoscopic hysterectomy does not provide a significant benefit in psychological general wellbeing for woman compared with abdominal hysterectomy up to 6 months after the operation. Operating time is significantly longer for laparoscopic hysterectomy but the stay in hospital and sick-leave are significantly shorter. The effects of surgery on other functions such as sexual behaviour and function have still not been fully evaluated, particularly for laparoscopic hysterectomy.

Acknowledgements

The study was supported financially by grants from the Medical Research Council of South East Sweden. The physicians and research nurses in the multicentre study group are thanked for their invaluable work and support in the study. The gynaecological surgeons who participated in the study group were: Raymond Lenrick, Ryhov Central Hospital, Jönköping; Urban Jürgensen, Johan Holmberg, County hospital, Eksjö; Magnus Jägerhorn, Mikael Algovik, Västervik County Hospital, Västervik; Kenneth Krohn, Vrinnevi Central Hospital, Norrköping; Lars Fåhraeus, P.P. and P.K., University Hospital, Linköping.

Ancillary