|- candidate number||23982|
|- NTR Number||NTR5615|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-feb-2016|
|- Secondary IDs||NL52652.029.15 METC VUMC|
|- Public Title||QUality of life after Embolization vs. hySTerectomy in Adenomyosis.|
|- Scientific Title||Uterine artery embolization versus hysterectomy for symptomatic adenomyosis:a randomized controlled trial.|
|- ACRONYM||QUESTA trial: QUality of life after Embolization vs. hySTerectomy in Adenomyosis.|
|- hypothesis||This study aims to evaluate the impact of UAE on Quality of life (QOL) in comparison to hysterectomy in adenomyosis patients. |
|- Healt Condition(s) or Problem(s) studied||Adenomyosis|
|- Inclusion criteria||• Premenopausal women with MRI confirmed symptomatic adenomyosis or dominant adenomyosis in combination with fibroids. |
• Premenopausal women with an indication for hysterectomy.
• No wish to conceive in the present or future
• Able to understand Dutch language.
|- Exclusion criteria||• Younger than 18 years of age|
• Pelvic infection/Suspicion or presence of malignancy
• Current pregnancy
• Contra-indication for angiography (such as contrast fluid allergy, coagulopathy and renal failure), when not treatable
• Deep infiltrating endometriosis requiring surgery or with risks on intestinal stenosis
• Concurrent removable submucous fibroids (Patients eligible after removal)
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-nov-2015|
|- planned closingdate||1-nov-2018|
|- Target number of participants||96|
|- Interventions||Uterine artery embolization -> experimental treatment|
Hysterectomy -> standard care
Randomization in 2:1 ratio (embolisation 2 versus hysterectomy 1)
|- Primary outcome||• Quality of life: |
To demonstrate non inferiority of treatment of adenomyosis with uterine artery embolization compared to treatment by hysterectomy in terms of quality of life at 26, 52 and 104 weeks after treatment (measured by WHOQOL-Bref and SF-12)
|- Secondary outcome||The two treatments will also be compared in terms of:|
• Clinical outcomes (PBAC, NRS 0-100 scale, Facet 1:Pain and discomfort WHOQOL-100, Satisfaction with allocated treatment (likert-scale), patient preference)
• Recovery related outcomes (RI-10)
• Quality of life outcomes (HOQOL-Bref and SF-12)
• Cost outcomes (EQ-5D)
• Imaging outcomes (uterine size reduction, infarction rate, junctional zone reduction, concomitant fibroids)
|- Timepoints||Measurements: will be taken at baseline and 6, 12, 26, 52 and 104 weeks after therapy.|
|- Trial web site||www.questa-studie.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Annefleur de Bruijn|
|- CONTACT for SCIENTIFIC QUERIES||Dr W.J.K. Hehenkamp|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief summary||Adenomyosis is defined as the benign invasion of endometrial stroma and glands in the myometrium, surrounded by hypertrophic and hyperplastic myometrium. Hysterectomy is established as the final treatment option when conservative treatment fails. Case series for UAE (uterine artery embolization) in adenomyosis patients show promising results. However, a randomized controlled trial is lacking.
Objective of the study:
This study aims to evaluate the impact of UAE on Quality of life (QOL) in comparison to hysterectomy in adenomyosis patients. A cost-effectiveness study will be part of the trial as well as a cohort hysterectomy group to clearify imaging and diagnosis of adenomyosis.
Non-blinded randomized controlled trial and cohort alongside the trial.
Premenopausal women without the desire to conceive and who have symptomatic MRI confirmed pure adenomyosis or dominant adenomyosis in combination with fibroids. (If the deep fibroids are clearly less to the extent of adenomyosis in terms of volume we consider it dominant adenomyosis)
Intervention (if applicable):
UAE, performed by experienced interventional radiologists versus hysterectomy (laparoscopically, abdominally or vaginally).
Primary study parameters/outcome of the study:
Primary endpoint: quality of life as measured by a combination of the World Health Organization Quality-of-Life Scale (WHOQOL-Bref) and short-form-12 (SF-12) questionnaire at 26 weeks after therapy.
Secundary study parameters/outcome of the study (if applicable):
The two treatments will also be compared in terms of Clinical outcomes, Recovery related outcomes, Quality of life outcomes and cost outcomes. Also imaging outcomes will be investigated at baseline in order to identify potential predictive parameters for therapy effect.
|- Main changes (audit trail)|
|- RECORD||17-feb-2016 - 18-feb-2016|