The objective of the study is to examine the opinion of women about the accuray of frozen section diagnosis. A important question is how women feel about a second operation in case of a false negative testresult.
ID
Source
Brief title
Condition
- Ovarian and fallopian tube disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The questionnaires will be analysed.
Secondary outcome
not applicable
Background summary
To reach optimal surgical treatment of ovarian masses it is important to
differentiate between the malignant ovarian masses and benign ovary. During
surgery frozen section diagnosis can be useful. The pathologist examines the
most suspected part of the tumor and judges whether it is benign or malignant.
This fast type of examination has a high specificity with acceptable
sensitivity. The diameter of the tumor and its histological type influence the
accuracy of frozen section diagnosis. In case of a false negative testresult
the surgeon removes just one of the ovaries under suspicion of benign
pathology. After one week the parafine diagnosis shows malignancy and the
patient needs a second operation in which the other ovary, the uterus and
omentum have to be removed, lymfnode sampling has to take place and biopsies of
the peritoneum.
Study objective
The objective of the study is to examine the opinion of women about the accuray
of frozen section diagnosis. A important question is how women feel about a
second operation in case of a false negative testresult.
Study design
All women who are scheduled for surgery because of an ovarian mass in the
Maxíma Medical Centre are eligible for inclusion into the study. The
gynecologist provides verbal and written information to the patient. If the
patient agrees to cooperate the study nurse contacts the patient by telepfone.
The study nurse invites the patients for a visit at the out patients'
department. After informed consent has been signed, the study nurse offers help
during answering the questionnaire. The study nurse is not informed about the
kind of pathology of the ovarian mass and consequently not aware of a possible
increased risk of malignancy. After six weeks the patient is asked to answer
the questionnaire again.
Study burden and risks
There are no risks for the study population. Treatment of the patient is
independent of the questionnaire. The study nurse is not informed about the
kind of pathology of the ovarian mass and consequently not aware of a possible
increased risk of malignancy.
Postbus 7777
5500 MB Veldhoven
Nederland
Postbus 7777
5500 MB Veldhoven
Nederland
Listed location countries
Age
Inclusion criteria
patients with an ovarian mass, prepared to answer a questionnaire
Exclusion criteria
none
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 | NL12470.015.06 |