| Title |
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
|
|---|---|
| Published in |
ClinicoEconomics and Outcomes Research: CEOR, April 2018
|
| DOI | 10.2147/ceor.s155038 |
| Pubmed ID | |
| Authors |
Darrien D Rattray, Laura Weins, Lexy C Regush, James M Bowen, Daria O’Reilly, John A Thiel |
| Abstract |
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. 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. 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). 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. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Canada | 1 | 50% |
| Unknown | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 2 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 50 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 50 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 8 | 16% |
| Researcher | 6 | 12% |
| Student > Bachelor | 5 | 10% |
| Other | 4 | 8% |
| Student > Doctoral Student | 3 | 6% |
| Other | 3 | 6% |
| Unknown | 21 | 42% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 17 | 34% |
| Pharmacology, Toxicology and Pharmaceutical Science | 2 | 4% |
| Biochemistry, Genetics and Molecular Biology | 2 | 4% |
| Business, Management and Accounting | 1 | 2% |
| Arts and Humanities | 1 | 2% |
| Other | 4 | 8% |
| Unknown | 23 | 46% |
Attention Score in Context
This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 23 April 2018.
All research outputs
#15,578,661
of 25,461,852 outputs
Outputs from ClinicoEconomics and Outcomes Research: CEOR
#286
of 525 outputs
Outputs of similar age
#188,844
of 344,029 outputs
Outputs of similar age from ClinicoEconomics and Outcomes Research: CEOR
#5
of 8 outputs
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