Primary Objective: The painscores regarding abdominal pain among women with primary outflow obstruction in comparison with an age matched control group.Secondary Objective(s): The prevalence of sexual problems due to the congenital anomalies or theā¦
ID
Source
Brief title
Condition
- Congenital and hereditary disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The painscores regarding abdominal pain among women with primary outflow
obstruction in comparison with an age matched control group.
Secondary outcome
The prevalence of sexual problems due to the congenital anomalies or the
subsequent therapy.
The rate of women that tried to become pregnant and experienced problems
regarding fertility due to the congenital anomalies or sequalae.
The use of painkillers and other therapies among women with primary outflow
obstruction in comparison with an age matched control group.
Background summary
The menstrual outflow of blood can be obstructed due to congenital anomalies of
the vagina, uterus or the uterine cervix. These anomalies are very low
prevalent in the female population, but it results in a typically severe
abdominal pain.
It is important to improve the care for girls with this anomalies, to
minimalize the side effects such as long lasting pain before the first surgery,
psycho-emotional harm, scar formation or organ damage.
Over the first few months of obstructed menstrual blood outflow the girls
experience a progressive abdominal pain. The obstruction can cause
endometriosis in the abdomen due to reversed menstrual blood into the abdominal
cavity. Sensitization of the nervous system (pain hypersensitivity) may also
play a role in subsequent pain problems.
Long-term studies on the effects of these problems, before and after the
primary surgery, are scarce. There is a study that describes the lessons from
30 cases of congenital anomalies of the uterine cervix (American society for
Reproductive Medicine 2010 (94), Rock J., Roberts C. et al). But in this
article the long term complications are not the object of study. This article
also explains that the obstetric complications have not been fully reported.
To improve the care for women with the congenital anomalies as described above,
it is important to investigate the long-term complications that woman report
who underwent a surgical correction of the outflow canal of the vagina or the
uterus. We also want to investigate whether these women experienced problems
during sexual intercourse and fertility (to become pregnant or problems during
their pregnancy) due to the congenital anomalies or the sequalae of the surgery.
It is important to inform doctors and patients on long-term effects and
complications, and therefore it is considered necessary to perform this case
control study.
Study objective
Primary Objective: The painscores regarding abdominal pain among women with
primary outflow obstruction in comparison with an age matched control group.
Secondary Objective(s): The prevalence of sexual problems due to the congenital
anomalies or the subsequent therapy.
The rate of women that tried to become pregnant and experienced problems
regarding fertility due to the congenital anomalies or sequalae.
The use of painkillers and other therapies among women with primary outflow
obstruction in comparison with an age matched control group.
Study design
This is a long-term case control study among women with congenital anomalies of
the vagina, the uterus or the uterine cervix who underwent a surgical
correction of the menstrual outflow canal in the Radboudumc dept ob/gyn in the
past 30 years. There are two surgeon*s patient lists (Wim Willemsen and Kirsten
Kluivers) which are expected to be complete since 1980 and will be used for the
purpose. We will send a letter, without details on the conditions studied, to
ask the women whether they are willing to participate in a questionnaire study.
The family doctors will be contacted to check whether addresses are still
actual among women who have not been seen in the clinic for more than 5 years.
After receiving patient*s agreement we will sent out a questionnaire and ask
them to fill-out that list. With their answers we make an inventory of the
problems they experienced after their reconstruction surgery as well as
effective treatments/ strategies. They main issues of the questionnaire are on
experienced abdominal pain, problems regarding sexual intercourse and
fertility.
We also make a comparision to questionnaire scores and VAS-painscore in a
cohort women without obstructive anomalies. The control group will be recruited
through a family doctor, who asks women of the same age as the researchgroup,
without gynaecological problems, whether they want to fill-out the
questionnaires for the study purpose.
Study burden and risks
This study is an inventory of the problems that women experienced in the years
after the surgery of their congenital anomalies of their vagina, uterus of
uterine cervix, so there are no risks associated with participation. It can be
a burden to fill-out the questionnaires. We expect that women will be willing
to participate.
Risk: time consumption 30 minutes.
Geert Grooteplein 10 Zuid -
Nijmegen 6525 GA
NL
Geert Grooteplein 10 Zuid -
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
The subjects of the group of patients meet the following requirements:
Women with congenital anomalies of the vagina, the uterus or the uterine cervix who underwent a reconstruction surgery of the menstrual outflow canal in the past.
The subjects of the control group meet the following requirements:
Women visiting the family doctor for other than gynaecological problems of the same age as the women in de patient group.
Exclusion criteria
Women will not be eligible for entry into the present study if they meet one of the following criteria:
a. Are unwilling or unable to fill-out the questionnaire.
b. The current address of the women can not be found.
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 | NL50025.091.14 |