Can prolonged sick leave after gynecologic surgery be predicted? An observational study in the Netherlands

BACKGROUND: Sick leave frequently has been used as an outcome to evaluate minimal invasive surgery compared with conventional open surgery. However, sick leave is determined not only by the surgical approach. Recently, a postoperative recovery-specific quality-of-life questionnaire, the Recovery Index (RI-10), has been developed and validated. This study investigated the relation of the Recovery Index 10, the RI-6 (a subset of 6 questions), and the type of surgery to sick leave. METHODS: The study enrolled 46 patients with a paid job scheduled for elective gynecologic surgery, who filled out the RI-10. After 8 weeks, the patients were approached by telephone to give information on their return to work. RESULTS: Of the 46 patients, 23 (50%) returned to work completely after 8 weeks, 14 (30%) resumed work partly, and 9 (20%) did not resume work at all. In the analysis, the patients who completely returned to work were compared with those who did not return or partially returned. Recovery as expressed in the RI-6 improved with time after surgery. It appeared that the measurement 2 weeks after surgery showed the best discriminative capacity to predict sick leave after 8 weeks, with an area under the curve of 0.88 (confidence interval, 0.74-1.03). The subjective postoperative recovery as expressed by the RI-6 is more closely related to the type of surgery (p = 0.001) sick leave is (p = 0.14). CONCLUSIONS: The subjective recovery scored by the patient on a questionnaire of six questions is a better outcome than sick leave for evaluating surgical approaches. If administered 2 weeks after surgery, it may predict prolonged sick leav

Electronic Continuous Pain Measurement vs Verbal Rating Scale in gynaecology:A prospective cohort study

OBJECTIVE: To compare pain measured with a new electronic device - the Continuous Pain Score Meter (CPSM) - and the Verbal Rating Scale (VRS) during gynaecological procedures in an outpatient setting, and to correlate these outcomes with baseline anxiety and patient (in)tolerance to the procedure. STUDY DESIGN: This prospective cohort study was undertaken in two centres: a university hospital and a large teaching hospital in The Netherlands. Patients undergoing an outpatient hysteroscopy, colposcopy or ovum pick-up procedure for in-vitro fertilization in one of the two participating hospitals with availability of the CPSM were included. Pain was measured by both the CPSM and the VRS. Patient tolerance to the procedure was reported. Various outcomes of the CPSM were compared with those of the VRS and related to baseline anxiety scores. RESULTS: Ninety-one of 108 included patients (84 %) used the CPSM correctly during the procedure, and it was possible to analyse the CPSM scores for 87 women (81 %). The CPSM scores were all linearly related to the VRS. The peak pain score on the CPSM (CPSM-PPS) had the strongest correlation with the VRS score for all three procedures. Higher CPSM-PPS was related to patient (in)tolerance to the procedure (p = 0.03-0.002). Anxiety at baseline was not correlated with pain perception, except for VRS during colposcopy (r = 0.39, p = 0.016). CONCLUSION: The majority of patients were able to use the CPSM correctly, resulting in detailed information on pain perception for each individual pain stimulus during three outpatient gynaecological procedures. The CPSM-PPS had the strongest correlation with the VRS score and patient (in)tolerance to the procedure

Total laparoscopic hysterectomy versus total abdominal hysterectomy with bilateral salpingo-oophorectomy for endometrial carcinoma: a randomised controlled trial with 5-year follow-up

This report is on recovery and long-term outcomes in a small-scale randomised controlled trial (RCT) after total laparoscopic hysterectomy versus total abdominal hysterectomy in (potential) endometrial carcinoma patients. An RCT was performed among women with atypical endometrial hyperplasia and endometrial carcinoma scheduled for hysterectomy in a teaching hospital in The Netherlands. Women were randomised to total laparoscopic hysterectomy versus total abdominal hysterectomy both with bilateral salpingo-oophorectomy and were followed until 5 years after the intervention. Patients completed the RAND 36-Item Short Form Health Survey (RAND-36), Quality of Recovery-40 (QoR-40) and Recovery Index-10 (RI-10) until 12 weeks after surgery. Main outcome measure was quality of life and recovery in the first 12 weeks after surgery. A linear mixed model was used for statistical analysis while accounting for baseline values where applicable. Seventeen women were included, of whom 11 allocated to the laparoscopic arm and 6 to the abdominal arm. Laparoscopic hysterectomy performed better on all scales and subscales used in the study. A statistically significant treatment effect, favouring laparoscopic hysterectomy, was found in the total RAND-36 (difference between groups 142 units, 95% confidence interval 46; 236). Clinical follow-up was completed after median 60 months, but this study was too small for conclusions regarding the safety and survival. Laparoscopic hysterectomy results in better postoperative quality of life in the first 12 weeks after surgery when compared with abdominal hysterectomy

Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed.</p> <p>Methods/Design</p> <p>We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old) undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university) hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery.</p> <p>Discussion</p> <p>The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably.</p> <p>Trial registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2087">NTR2087</a></p

Bipolar radio frequency endometrial ablation compared with balloon endometrial ablation in dysfunctional uterine bleeding: Impact on patients' health-related quality of life

Objective: To compare health-related quality of life (HRQoL) after bipolar radio frequency ablation and thermal balloon ablation in women with dysfunctional uterine bleeding. Design: Randomized clinical trial. Setting: Teaching hospital. Patient(s): Women suffering from dysfunctional uterine bleeding. Intervention(s): Bipolar radio frequency ablation and thermal balloon ablation. Main Outcome Measure(s): Patients were asked to complete HRQoL questionnaires at baseline, and at 2 days, 2 weeks, 3 months, 6 months, and 12 months after surgery. The questionnaires contained the medical outcomes study Short-Form 36 (SF-36), the Self-rating Depression Scale, the Rotterdam Symptom Checklist, State-Trait Anxiety Inventory, and a structured clinical history questionnaire. Result(s): Data on HRQoL were available on at least two different time points in 115 and 126 randomized patients. HRQoL improved significantly over time in both groups, except for the domain of general health in the SF-36. None of the dimensions showed a significant difference between both groups, neither was there a significant interaction between time and treatment effect. Conclusion(s): Both methods significantly improved HRQoL in women with dysfunctional uterine bleeding. However, despite better amenorrhea and satisfaction rates after bipolar radio frequency ablation, there was no difference in HRQoL between the two groups. (c) 2005 by American Society for Reproductive Medicin

Cost-effectiveness of the use of transvaginal sonography in the evaluation of postmenopausal bleeding

OBJECTIVES: To assess the cost-effectiveness of transvaginal sonography (TVS) in the diagnostic work-up of women with postmenopausal bleeding. METHODS: We performed a decision analysis in which we estimated life expectancy and cost of four strategies for the evaluation of postmenopausal bleeding: TVS (I), TVS and office endometrial biopsy (II), TVS and hysteroscopy (III), and endometrial biopsy (IV). In strategies incorporating TVS, calculations were performed for three different cut-off values between 3 and 9 mm double layer. Expectant management, i.e. no diagnosis or treatment was considered to be the reference strategy to which the other four strategies were compared. Data were obtained from the published literature. In extensive sensitivity analyses, we varied patient's age, discount rate, prevalence of endometrial carcinoma and atypical hyperplasia, and costs. RESULTS: The strategy with endometrial biopsy and the strategy with TVS followed by endometrial biopsy in case of an increased endometrial thickness were the most cost-effective strategies. The strategy starting with endometrial biopsy was the most cost-effective when the prevalence of endometrial carcinoma was > or =15.3%, whereas the strategy with TVS and endometrial biopsy was the most cost-effective for women in which the prevalence of endometrial carcinoma was lower. In these strategies, a cut-off level for abnormality of 9 mm resulted in lowest cost per life-year gained. CONCLUSIONS: TVS is of use in women with postmenopausal bleeding and a probability of endometrial carcinoma below 15

Randomised controlled trial of bipolar radio-frequency endometrial ablation and balloon endometrial ablation

OBJECTIVE: To compare the effectiveness of two second-generation ablation techniques, bipolar radio-frequency impedance-controlled endometrial ablation (NovaSure) and balloon ablation (ThermaChoice), in the treatment of menorrhagia. DESIGN: Double-blind, randomised, controlled trial. SETTING: A large teaching hospital with 500 beds in The Netherlands. POPULATION: Women suffering from menorrhagia referred by their general practitioner. METHODS: Women suffering from menorrhagia, without intracavitary abnormalities, were randomly allocated to bipolar radio-frequency ablation (bipolar group) and balloon ablation (balloon group) in a 2:1 ratio. At follow up, both women and observers were unaware of the type of treatment that had been performed. MAIN OUTCOME MEASURES: The main outcome measure was amenorrhea at 3, 6 and 12 months after randomisation. RESULTS: One hundred and twenty-six women were included in the study, of which 83 were allocated to the bipolar group, and 43 to the balloon group. No complications occurred in either of the treatment groups. At the one-year follow up stage, amenorrhea rates were 43% (34/83) in the bipolar group and 8% (3/43) in the balloon group (treatment effect in time P < 0.001). At this stage, 90% of the patients in the bipolar group were satisfied with the result of the treatment against 79% in the balloon group (treatment effect in time P= 0.003). CONCLUSION: The bipolar radio-frequency impedance-controlled endometrial ablation system is more effective than balloon ablation in the treatment of menorrhagi