Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life and costs.
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total blood loss during laparoscopic myomectomy will be our main study
parameter.
Null-hypothesis: Ulipristal is non-inferior to GnRHa in terms of blood loss
during surgery when the average difference between the two groups is below 150
ml (standard deviation 250 ml).
Secondary outcome
Secondary outcomes parameters will be reduction of fibroid volume after
pre-treatment assessed by 3 dimensional ultrasound (possibility to perform
detailed volume assessments afterwards), hemoglobin levels pre- and post
operatively, conversion rate to laparotomy, complication rate, re-intervention
rate, operative time, surgical ease (see table beneath tis paragraph),
breaching of uterine cavity, pain scores and use of analgesia post operatively,
quality of life during pre-operative treatment and post-operatively up till 6
months. The fibroid tissue will be histologically investigated to assess
vascular density and histological composition. A small part of the removed
tissue will be kept apart for this purpose. Direct and indirect medical and
non-medical costs will be used to perform a cost utility analysis.
Also, patients that do not want to participate (no pre-treatment) will be asked
to be included in the non-randomized control group:
Title: pre-treatment versus no pre-treatment prior to laparoscopic myomectomy:
a non-randomized comparison.
Objectives: same objectives as main study (pre-treatment versus
no-pre-treatment)
Methods: Eligible patients that are not willing to participate in the trial
will not be pre-treated, or will be treated with the gold standard: GnRHa.
Those patients that choose not to be pre-treated will be asked to participate
in the untreated, not-randomized control group and will (after informed
consent) follow the same study flow as the randomized patients. This way,
pre-treatment in general can be compared to no pre-treatment.
Background summary
Rationale: Laparoscopic myomectomy is increasingly performed over laparotomic
myomectomy, because of the many benefits for the patient in terms of pain,
hospital stay and recovery. In order to increase the success rate of a
laparoscopic procedure pre-treatment to decrease the volume might be
beneficial. Gonadotropin-releasing hormone agonists (GnRHa) are used for this
purpose with good results in terms of volume reduction, but sometimes resulting
in loss of distinction of the right surgical planes. Ulipristal is a new
pre-operative treatment option for symptomatic fibroids, which has demonstrated
good results in terms of volume reduction. The effect on cleavage planes is
unknown. This study is performed to evaluate if Ulipristal is as effective as
GnRHa in terms of surgical outcome.
Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of
intra-operative blood-loss (primary outcome), surgical time, surgical ease,
complications, quality of life and costs.
Study objective
Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of
intra-operative blood-loss (primary outcome), surgical time, surgical ease,
complications, quality of life and costs.
Study design
Study design: Double blind randomized controlled multi-center trial.
Intervention
Intervention: Three months of Ulipristal 5 mg once daily combined with a saline
injection (produced as placebo of Leuproreline) or (comparison)a single 11.25
mg Leuproreline injection with placebo tablets (once daily) .
Study burden and risks
Both Ulipristal and GnRHa have been registered for this indication. Safety has
been tested and no specific risks apply.
De Boelelaan 1117
Amsterdam 1081 HZ
NL
De Boelelaan 1117
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Women visiting the gynecological outpatient department with symptomatic fibroids will be screened for eligibility. In order to be eligible to participate in this trial, a subject must meet all of the following criteria:
* provide written consent prior to any study related procedures
* pre-menopausal
* a planned resection of a maximum of 2 FIGO (PALM-COEIN classification)
type 3, 4, 5, 6 or 2-5 fibroids of >5 cm
* the(se) fibroid(s) should be between 5 and 12 cm (maximum diameter)
* other fibroids should be small (<2 cm), not clinically relevant, or not resectable
(e.g. difficult position), or type 7 (any size)
* eligible for laparoscopic myomectomy
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this trial:
* pregnancy
* (suspicion of) malignancy
* any type 0-2 fibroids smaller than 5 cm
* more than 2 type 3-6 fibroids > 5 cm that need to be removed (except type 7
fibroids of any size)
* use of any hormonal agents and not willing to discontinue their use
* use of anticoagulants
* coagulopathy
* Use of NSAIDs impacting bleeding before surgery
* Contraindication to laparoscopy procedure or causes of complications
(multiple laparotomies, frozen pelvis, severe endometriosis)
* allergy to leuprolide acetate/comparable nonapeptides or Ulipristal
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-002832-15-NL |
| CCMO | NL49916.029.14 |