The primary objective of this study is to evaluate the technical success, feasibility and safety of hysteroscopic US guided cryomyolysis procedure.
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Safety of the procedure will be assessed by incidence and severity of intra
and post procedure related adverse events (AE) up to 4 weeks post procedure.
2) Technical success and procedure feasibility will be assessed by:
o Identification of fibroid under ultrasound
o Visibility of needles under ULS
o Insertion of needles to the fibroid and positioning of the needle in the
fibroid
o Visibility of the fibroid and needle by the hysterospcope optics
o Visibility of ice ball propagation and fibroid optimal coverage
o Type of fibroid and location and impact on success rate
Secondary outcome
o Hysteroscopic cryomyolysis related pain will be measured by self reported
pain severity Visual Analogue Scale (VAS) completed by the patient prior to
discharge from hospital.
o Time (in days) to return to normal activity (reported by the patient at 4
weeks follow-up visit and recorded in the CRF).
o Average duration of post operative hospital stay.
o Evaluation of length of an average procedure.
o Physician's satisfaction from the ease and convenience of the hysteroscopic
cryoablation procedure will be documented in a satisfaction questionnaire.
Background summary
The reported literature reports promising results for the use of cryomyolysis
as a minimally invasive, conservative treatment modality for uterine myomas.
Thus far, most studies have used either laparoscopic guidance or MRI-guidance
for the procedure.
This proposed feasibility study is looking to examine the technical success,
safety and feasibility of a hysteroscopic approach for the treatment of
symptomatic fibroids. This technique involves a hysteroscopically placed
Galil-Medical 17-G Cryotherapy needle(s) during conventional hysteroscopy with
an operative hysteroscope.
This treatment could offer several potential benefits over a laparoscopic
approach or MRI guided procedure. First, a hysteroscopic procedure is
associated with fewer risks than a laparoscopic procedure. No abdominal access
is needed with hysteroscopy, and thus is not associated with the rare but
potentially morbid complications associated with laparoscopy. Furthermore, the
use of MRI has limited availability and high associated costs. Hysteroscopy is
available to most gynecologists in most centers, and so could be used by many
providers without significant extra training.
Most importantly, submucous myomata that comprise 10-15% of all fibroids, are
the most likely fibroids to cause symptoms such as heavy uterine bleeding.
These fibroids are best accessed via a hysteroscopic or transvaginal approach.
Study objective
The primary objective of this study is to evaluate the technical success,
feasibility and safety of hysteroscopic US guided cryomyolysis procedure.
Study design
The procedure is planned after preparatory counseling and examinations as usual
for hysteroscopic treatment of submucous myoma*s.
The procedure is performed in the operating theater under visual ultrasound
guidance. See protocol 7.1
Intervention
Hysteroscopic cryomyolysis under visual ultrasound guidance
Study burden and risks
Risks:
The risks associated with hysteroscopic cryomyolysis are similar to other
hysteroscopic procedures. There is a large experience with diagnostic and
operative hysteroscopy in which the complication rate is in the 1-2% range. In
experienced hands however the complication rate is even much lower: up to a 16
fold difference between experienced (> 1000 procedures) and less experinced (<
1000 procedures) has been reported.
* Uncommon complications associated with operative hysteroscopy include;
Infection, bleeding, and uterine perforation possibly leading to injury to
internal organs such as bladder, bowel and blood vessels. Additionally, there
is a risk of fluid absorption as fluid is used for uterine distention during
operative hysteroscopy. Weighted measuring systems and strict rules regarding
fluid deficits are used in all hysteroscopic procedures making this
complication extremely rare.
* Additional potential complications from the cryomyolysis include extension of
the ice ball past the fibroid and uterine myometrium with the possibility of
damaging adjacent organs.
* To limit this risk, the cryomyolysis is performed under ultrasound guidance
to monitor the ice ball formation. The ice ball is only formed to within the
fibroid, leaving a margin of safety,
* since the iceball margins reach temperature of zero which is not lethal. The
cryoneedle can be manually controlled to stop the freezing process at any time.
* Intraoperative or postoperative bleeding requiring blood transfusion and/or
conversion to open surgery. Bleeding occurring from the fibroid surface after
extraction of the cryoneedles * refers usually to oozing which is controlled by
local cauterization of the bleeding site.
* Adhesion formation may result like in any other surgical procedure but its
risk is minimized by minimizing serosal surface trauma, bleeding and infection
* Thromboembolism can occur like in any other Gynecologic procedure, although
the procedure does not involve manipulation of pelvic vasculature or prolonged
immobility. Hysteroscopic cryomyolysis treatment will be performed under
standard Thromboembolism-preventing care.
* Risks of anesthesia * may occur like in any other procedure. The risk from
anesthesia may include allergic reaction to medications which may result in
serious patient injury or even death.
Potential Benefits:
Individuals participating in this study may benefit from hysteroscopic
cryomyolysis in several ways:
* If successful, this procedure allows the patient to preserve her uterus by a
minimally invasive procedure.
* Type II submucous myomas, which are often very difficult to completely and
safely remove hysteroscopically, are often treated through an open or
laparoscopic procedure. Hysteroscopic procedure does not involve
intraperitoneal intervention and is therefore expected to be associated with
less intra-operative and post-operative complications.
* Fast recovery: after hysteroscopic cryomyolysis only minimal self resolving
discomfort is expected and the patient should be able to return to her normal
activity within 24-48 hours.
* Hysteroscopic cryomyolysis could broaden the number of providers able to
offer patients a hysteroscopic treatment option.
Tavor Building, POB 224
20692 Yokeam
Israel
Tavor Building, POB 224
20692 Yokeam
Israel
Listed location countries
Age
Inclusion criteria
* Primary complaint is excessive bleeding
* Subject is able to understand and give informed consent for participation in the study
* Pre-menopausal woman between the ages of 30 and 50 (inclusive)
* Has completed childbearing and not contemplating future fertility
* Has symptomatic uterine fibroids
o Symptomatic subjects defined as
* Abnormal uterine bleeding
* Either menorrhagia or metrorrhagia, or menometrorrhagia (with no infectious or pre-malignant/malignant cause of bleeding)
* Socially disruptive bleeding
* Bleeding defined as bothersome to the patient that interferes with daily activities
* Fibroids type, size, location and number
o 1 submucosal fibroid
o Type I and Type II fibroids
o 2 to 4cm
* Using contraception to prevent pregnancy
Exclusion criteria
* Any evidence of known or suspected infection or pre-malignancy/malignancy
* Desire for future child bearing
* Use of GnRH analogues within 3 months prior to cryotherapy treatment
* Fibroids
o Size > 4 cm
o 2 or more submucosal fibroids
o Fibroid distance from serosa is less than 1 cm
Design
Recruitment
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 |
|---|---|
| CCMO | NL20928.029.07 |