Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399744
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2024-05-01
Brief Title:
Role of Sclerotherapy in Treatment of Non-neoplastic Ovarian Cyst
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
Official Title:
Role of Sclerotherapy in Treatment of Non-neoplastic Ovarian Cyst
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 285 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
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 285 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None