Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247923
Status:
COMPLETED
Last Update Posted:
2011-07-06
First Post:
2005-10-31
Brief Title:
Endometrial Polyps Pathophysiology and Clinical Consequences
Sponsor:
Ullevaal University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Endometrial Polyps Pathophysiology and Clinical Consequences
Status:
COMPLETED
Status Verified Date:
2009-02
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 these studies is to study the natural history the symptoms of as well as the effect of hysteroscopic resection of endometrial polyps Furthermore another aim is to study new diagnostic techniques to differentiate between malignant and benign endometrial polyps
Detailed Description:
Study Part 1 New diagnostic methods for the prediction of malignancy in endometrial polyps A prospective pilot study
Study of angiogenesis by identification of specific angiogenesis factors in tissue biopsies from the endometrium and by Doppler ultrasound combined with IV contrast We hope to find specific characteristics with new vessel formation in the endometrial polyp which can play a role in the prognostic evaluation regarding the risk for cancer development We will compare women with endometrial polyps and women with endometrial cancer to see if these methods of angiogenesis evaluation may be useful in separating benign polyps from premalignant and malignant polyps
Study Part 2 The natural history of endometrial polyps A prospective randomised study of patients with endometrial polyps
Blood loss during menstruation is documented with the help of a standardized form PBAC The patients are randomized to hysteroscopic resection of the endometrial polyp or 6 months of observation A new registration of blood loss during menstruation is performed by patients in both groups In the intervention group a new gynaecological examination 6 months after the resection documents the presence of residual polyp or symptoms The other group is examined again after 6 months of observation Symptoms and findings with the second examination are compared with symptoms and findings at the first examination any changes are documented and the final outcome in the to groups are compared
Study Part 3 The occurrence and natural history of asymptomatic endometrial polyps in perimenopausal women A prospective controlled study
Registration of blood loss during menstruation is documented with the help of a standardized form PBAC and gynaecological examination including SIS of 1000 randomly selected women in the age group 45-50 Where endometrial polyps are identified we document the size and number of polyps and an endometrial biopsy is taken After including a woman with an endometrial polyp in the study the next woman without endometrial polyp is recruited to the control group After one year blood loss during menstruation is registered again and all women with endometrial polyps as well as the control group have a new examination including vaginal ultrasound SIS and endometrial biopsy Symptoms and findings are compared with symptoms and findings at the first examination and all changes are documented If the woman has a persistent endometrial polyp when examined at 1 year she is offered treatment with hysteroscopic polyp resection
Study of angiogenesis by identification of specific angiogenesis factors in tissue biopsies from the endometrium and by Doppler ultrasound combined with IV contrast We hope to find specific characteristics with new vessel formation in the endometrial polyp which can play a role in the prognostic evaluation regarding the risk for cancer development We will compare women with endometrial polyps and women with endometrial cancer to see if these methods of angiogenesis evaluation may be useful in separating benign polyps from premalignant and malignant polyps
Study Part 2 The natural history of endometrial polyps A prospective randomised study of patients with endometrial polyps
Blood loss during menstruation is documented with the help of a standardized form PBAC The patients are randomized to hysteroscopic resection of the endometrial polyp or 6 months of observation A new registration of blood loss during menstruation is performed by patients in both groups In the intervention group a new gynaecological examination 6 months after the resection documents the presence of residual polyp or symptoms The other group is examined again after 6 months of observation Symptoms and findings with the second examination are compared with symptoms and findings at the first examination any changes are documented and the final outcome in the to groups are compared
Study Part 3 The occurrence and natural history of asymptomatic endometrial polyps in perimenopausal women A prospective controlled study
Registration of blood loss during menstruation is documented with the help of a standardized form PBAC and gynaecological examination including SIS of 1000 randomly selected women in the age group 45-50 Where endometrial polyps are identified we document the size and number of polyps and an endometrial biopsy is taken After including a woman with an endometrial polyp in the study the next woman without endometrial polyp is recruited to the control group After one year blood loss during menstruation is registered again and all women with endometrial polyps as well as the control group have a new examination including vaginal ultrasound SIS and endometrial biopsy Symptoms and findings are compared with symptoms and findings at the first examination and all changes are documented If the woman has a persistent endometrial polyp when examined at 1 year she is offered treatment with hysteroscopic polyp resection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 22200205 | None | None | None |