Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06399744 |
| Other study ID # |
sclerotherapy |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
February 28, 2024 |
Study information
| Verified date |
October 2022 |
| Source |
Al-Azhar University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study was to evaluate the role of sclerotherapy (injection of tetracycline or
injection of Polidocanol - 95% hydroxypolyethoxydodecane and 5% ethanol -) in treatment of
non-neoplastic ovarian cysts by, percutaneous trans-abdominal approach or trans-vaginal
approach.
Description:
Ovarian cysts are fluid-filled sacs that form in or on an ovary. Such cysts are relatively
common. Most are non-cancerous (benign) and disappear on their own. Ovarian cancer is more
likely to occur in women over 50.
Most of the patients with ovarian cyst are symptomless and resolves spontaneously. If
untreated, complications such as rupture, torsion, malignant transformation may occur.
Cyst rupture can lead to peritoneal signs, abdominal distension and bleeding, irregularity of
the menstrual cycle and abnormal vaginal bleeding, dull bilateral pelvic pain may result from
the lutein cysts.
Until recent times, surgery in the form of laparotomy or laparoscopy has been the first
choice. However, ultrasonography guided aspiration of the cysts as an alternative treatment
is the fast catching up and may even be procedure of choice in the management of ovarian
cysts in a selected group of women as it has low recurrence rate, low risk, less cost and in
most cases no hospital stay.
There are various types of ovarian cysts, such as functional cysts, follicular cysts, corpus
luteum cysts, hemorrhagic cysts, theca-lutein cysts, peritoneal inclusion cysts or
pseudo-cysts, polycystic ovaries and endometriomas.
Functional cysts do not regress when treated with combined oral contraceptives that they do
with expectant management.
Ovarian cysts are common, affecting 20% of women at some point in their lives . Unlike
unilocular cysts including septations, solid irregular wall, or internal plaques, the simple
ovarian cyst is defined as an anechoic round or oval lesion. The maximum diameter of simple
ovarian cysts in premenopausal women is less than 5 cm, they often disappear during the
menstrual cycle and do not require further intervention. Larger cysts (5-7 cm) should be
followed using ultrasonography. Cysts larger than 7 cm may require advanced imaging or
surgery.
Differential diagnosis in the management of an adnexal mass is complex because of the scope
of the disorders that may have caused it and the numerous therapies that may be appropriate.
It is the risk of malignancy that propels protocols and procedures, as well as the
fundamental concept that early diagnosis and treatment in cancer are related to lesser
mortality and morbidity. Non neoplastic ovarian cysts in women with menstrual cycles are the
most frequently detected masses involving the adnexa. Many of these cysts are functional and
resolve spontaneously within a few days to 2 weeks, but they can persist longer.
The management of women with benign ovarian cysts remains controversial. Various treatment
protocols use medical treatment (mainly oral contraceptives), ultrasound-guided aspiration,
laparoscopy (cystectomy or drainage and ablation of the cystic wall) and laparotomy
(cystectomy) Sclerotherapy of ovarian cysts has been attempted to decrease the probability of
recurrence. Although ultrasound-guided aspiration is simple and safe, the recurrence rate is
high, ranging from 28.5% to 100%. In order to reduce this rate, ultrasound-guided ethanol
sclerotherapy for ovarian cysts was first introduced in 1988, and it has been reported by
several authors to be simple and safe.
Tetracycline, methotrexate, and ethanol are the most common agents used for sclerotherapy.
When compared to women without cysts, sclerotherapy applied to infertile women with ovarian
cysts has been shown to reduce pelvic pain without affecting the number of follicles, term
pregnancy and abortion rates, the number of obtained oocytes, embryo quality, or hormonal
levels.
We chose either tetracycline or Polidocanol as sclerosing agents. Tetracycline because of its
antibacterial effect, which may help to control infections. Tetracyclines (tetracycline,
doxycycline, minocycline) have been used as sclerosing agent in various clinical settings
such as pleural effusions, pneumothoraxes, hydroceles, benign lymphoepithelial cysts of the
parotid gland and lymphoceles after renal transplantation.
Polidocanol is a nonionic surfactant sclerosing agent, which consists of 95%
hydroxypolyethoxydodecane and 5% ethanol. Polidocanol was invented as an anesthetic agent.
Polidocanol is a liquid surfactant having endothelial cell lytic properties.
The mechanism underlying the sclerosing effect was generally attributed to the results of
local chemical irritation or inflammatory response. Ethanol induces a combination of
cytotoxic damage, dehydration of cells, and production of mediators for inflammation and
fibrosis.
