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      Clinical outcomes and health care utilization pre- and post-laparoscopic radiofrequency ablation of symptomatic fibroids and laparoscopic myomectomy: a randomized trial of uterine-sparing techniques (TRUST) in Canada

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          Abstract

          Objective

          The objective of this study was to compare laparoscopic ultrasound-guided radiofrequency ablation of fibroids (Lap-RFA) and laparoscopic myomectomy in terms of 1) health care utilization and 2) serious complication rates. The secondary objectives were comparison of subject responses to validated symptom and quality-of-life questionnaires. We hypothesized that Lap-RFA health care utilization and clinical outcomes would not be worse than those of laparoscopic myomectomy in the aggregate.

          Patients and methods

          Post-market, randomized, prospective, multicenter, longitudinal, non-inferiority interventional comparative evaluation of health care utilization and clinical outcomes in premenopausal women with symptomatic uterine fibroids who desired uterine conservation was conducted. Both procedures were planned as outpatient day surgeries. Health care resource utilization was measured during the procedure day and at 1 week, 1 and 3 months post-surgery. Symptom severity and quality of life were based on patients’ responses to the Uterine Fibroid Symptom Severity and Quality-of-Life Questionnaire, EuroQol-5D-visual analog scale general health status and menstrual impact questionnaires, and time from work.

          Results

          Forty-five participants provided written informed consent and were enrolled (Lap-RFA, n=23; myomectomy, n=22) in Canada. Hospitalization time (primary endpoint) was 6.7±3.0 hours for the Lap-RFA group and 9.9±10.7 hours for the myomectomy group (Wilcoxon, p=0.0004). Intraoperative blood loss was lesser for Lap-RFA subjects: 25.2±21.6 versus 82.4±62.5 mL ( p=0.0002). Lap-RFA procedures took lesser time than myomectomy procedures: 70.0 versus 86.5 minutes ( p=0.018), and Lap-RFA required −34.9% (130 fewer) units of surgical equipment. At 3 months, both cohorts reported the same significant symptom severity reduction (−44.8%; p<0.0001). Lap-RFA subjects also took lesser time from work: 11.1±7.6 versus 18.5±10.6 days ( p=0.0193). One myomectomy subject was hospitalized overnight after experiencing a 20-second asystole during the procedure. One Lap-RFA subject underwent a reintervention. The combined per patient direct and indirect costs of the two procedures were comparable: Lap-RFA (CAD $5,224.96) and myomectomy (CAD $5,321.96).

          Conclusion

          Compared to myomectomy, Lap-RFA is associated with significantly lesser intraoperative blood loss, shorter procedure and hospitalization times, lesser consumption/use of disposable and reusable surgery equipment, reduced health care resource utilization, and faster return to work through 3 months posttreatment. Direct and indirect costs of Lap-RFA and myomectomy are comparable.

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          Most cited references 19

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          The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata.

          To create and validate a questionnaire for assessing symptom severity and symptom impact on health-related quality of life for women with leiomyomata. The questionnaire was derived from focus groups of women with leiomyomata. Content validity was established through cognitive debriefings of women with leiomyomata and review by expert clinicians. Patients for the validation study were recruited from five gynecologists' offices, an interventional radiology department, and a University campus. Instruments used for validation were the Short Form-36, Menorrhagia Questionnaire, the Revicki-Wu Sexual Function Scale, and a physician and a patient assessment of severity. Item and exploratory factor analysis were performed to assess the subscale structure of the questionnaire. Psychometric evaluation was conducted to assess reliability and validity. Test-retest was performed on a random subset of the sample within 2 weeks of the initial visit. A total of 110 patients with confirmed leiomyomata and 29 normal subjects participated in the validation. The final questionnaire consists of eight symptom questions and 29 health-related quality of life questions with six subscales. Subscale Cronbach's alpha ranged from 0.83 to 0.95, with the overall health-related quality of life score alpha = 0.97. The Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire subscales discriminated not only from normal controls but also among leiomyomata patients with varying degrees of symptom severity. Test-retest reliability was good with intraclass correlation coefficients of 0.76-0.93. The UFS-QOL appears to be a useful new tool for detecting differences in symptom severity and health-related quality of life among patients with uterine leiomyomata. Additional study is underway to determine the responsiveness of the UFS-QOL to therapies for leiomyomata.
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            On tests of the overall treatment effect in meta-analysis with normally distributed responses.

            For the meta-analysis of controlled clinical trials or epidemiological studies, in which the responses are at least approximately normally distributed, a refined test for the hypothesis of no overall treatment effect is proposed. The test statistic is based on a direct estimation function for the variance of the overall treatment effect estimator. As outcome measures, the absolute and the standardized difference between means are considered. In simulation studies it is shown that the proposed test keeps the prescribed significance level very well in contrast to the commonly used tests in the fixed effects and random effects model, respectively, which can become very liberal. Furthermore, just for using the proposed test it is not necessary to choose between the fixed effects and the random effects approach in advance. Copyright 2001 John Wiley & Sons, Ltd.
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              Complications of hysterectomy.

              Hysterectomy is the most common gynecologic procedure performed in the United States, with more than 600,000 procedures performed each year. Complications of hysterectomy vary based on route of surgery and surgical technique. The objective of this article is to review risk factors associated with specific types of complications associated with benign hysterectomy, methods to prevent and recognize complications, and appropriate management of complications. The most common complications of hysterectomy can be categorized as infectious, venous thromboembolic, genitourinary (GU) and gastrointestinal (GI) tract injury, bleeding, nerve injury, and vaginal cuff dehiscence. Infectious complications after hysterectomy are most common, ranging from 10.5% for abdominal hysterectomy to 13.0% for vaginal hysterectomy and 9.0% for laparoscopic hysterectomy. Venous thromboembolism is less common, ranging from a clinical diagnosis rate of 1% to events detected by more sensitive laboratory methods of up to 12%. Injury to the GU tract is estimated to occur at a rate of 1-2% for all major gynecologic surgeries, with 75% of these injuries occurring during hysterectomy. Injury to the GI tract after hysterectomy is less common, with a range of 0.1-1%. Bleeding complications after hysterectomy also are rare, with a median range of estimated blood loss of 238-660.5 mL for abdominal hysterectomy, 156-568 mL for laparoscopic hysterectomy, and 215-287 mL for vaginal hysterectomy, with transfusion only being more likely after laparoscopic compared to vaginal hysterectomy (odds ratio 2.07, confidence interval 1.12-3.81). Neuropathy after hysterectomy is a rare but significant event, with a rate of 0.2-2% after major pelvic surgery. Vaginal cuff dehiscence is estimated at a rate of 0.39%, and it is more common after total laparoscopic hysterectomy (1.35%) compared with laparoscopic-assisted vaginal hysterectomy (0.28%), total abdominal hysterectomy (0.15%), and total vaginal hysterectomy (0.08%). With an emphasis on optimizing surgical technique, recognition of surgical complications, and timely management, we aim to minimize risk for women undergoing hysterectomy.
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                Author and article information

                Journal
                Clinicoecon Outcomes Res
                Clinicoecon Outcomes Res
                Clinicoecon Outcomes Res
                ClinicoEconomics and Outcomes Research: CEOR
                Dove Medical Press
                1178-6981
                2018
                05 April 2018
                : 10
                : 201-212
                Affiliations
                [1 ]Department of Gynecology, Regina General Hospital, Regina, SK, Canada
                [2 ]Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan, Regina, SK, Canada
                [3 ]Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada
                [4 ]Programs for Assessment of Technology in Health (PATH), Research Institute of St Joe’s Hamilton, Hamilton, ON, Canada
                Author notes
                Correspondence: John A Thiel, Medical Professional Corporation, 100-2631 28th Avenue, Regina, Saskatchewan S4S6X3, Canada, Tel +1 306 586 1800, Fax +1 306 586 3511, Email drjthiel@ 123456aol.com
                Article
                ceor-10-201
                10.2147/CEOR.S155038
                5894744
                © 2018 Rattray et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Original Research

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