The primary aim is to evaluate sexual function in adults with congenital colorectal disease and sacrococcygeal teratoma. The secondary aim of this study is to evaluate whether additional information and care on this subject has been missed and would…
ID
Source
Brief title
Condition
- Congenital and hereditary disorders NEC
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the outcomes of the questionnaires used as
follows. For the exact content of the questionnaires we refer to section F1.
All the used questionnaires (including the quality of life questionnaire
mentioned in the secondary study parameters/endpoints) are used in
international studies, are validated in Dutch, and cross-culturally normed. For
these questionnaires, cut-off values are available in defining what is normal
and what is *sexual dysfunction*.
For female patients:
- Female sexual function index (FSFI): 19 items about sexual function.
- Female sexual distress scale (FSDS): 12 items about sexual distress.
For male patients:
- International index of erectile function (IIEF): 15 items about sexual
function and distress combined.
Secondary outcome
Secondary outcome parameters are to assess the disease-specific quality of life
in these patients, and to recruit a sounding board in providing the most
optimal information for future patients. This information will be obtained
through the following questionnaires.
For all patients:
- Hirschsprung*s disease and Anorectal malformation Quality of Life
questionnaire (HAQL):
o For patients without a stoma: 51 items about miction, defecation, and
quality of life.
o For patients with a stoma: 33 items about miction and stoma function, and
quality of life.
- A short self-developed questionnaire about satisfaction on the education
patients received on possible sexual problems: 6 items.
Patient characteristics from responders and non-responders will be obtained
from the medical records and will be compared. The results of the sexual
function questionnaires of patients with a low anorectal malformation will be
compared to those with a high malformation (according to the Krickenbeck
classification). For Hirschsprung*s disease, the same will be done for patients
with short segment vs. long segment + total aganglionosis.
Background summary
In 1999, we established a prospective long-term follow up outpatient clinic in
our department for children with congenital anatomical malformations, amongst
others congenital colorectal disease and sacrococcygeal teratoma. This
follow-up program is now standard of care. In this program the ages and
assessments at follow-up are standardized and tailor-made for the different
congenital anatomical malformations. The oldest participants of this follow-up
program now reach adolescent age and may become sexually active. Only a few
studies are available on sexuality in (young) adults with congenital colorectal
disease, with limited study samples and limited study questions. To provide
optimal care and education for the current population of adolescents with
colorectal malformations, more information on sexual function at older age is
needed.
Study objective
The primary aim is to evaluate sexual function in adults with congenital
colorectal disease and sacrococcygeal teratoma. The secondary aim of this study
is to evaluate whether additional information and care on this subject has been
missed and would have been necessary.
Study design
Cross-sectional study with internationally validated questionnaires on sexual
function and sexual distress.
Study burden and risks
Main benefit of participating in this study is that patients may become aware
that potential sexual problems could have a relationship with their congenital
anatomical malformation. Adequate referral for further evaluation and treatment
may be facilitated by our group. Patients will receive general information on
sexual problems (a brochure of the dept. of sexology) and in addition contact
names and addresses of the investigators will be given at the last
questionnaire. Patients can be referred to the general practitioner or the
sexologist specialized in sexual function problems in this patient group if
necessary. Risks of participating in the study are minimal.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Over 18 years of age at time of study, i.e. born before or in 1995.
- Anorectal malformation, Hirschsprung*s disease, or sacrococcygeal teratoma, treated in one of the participating centers.
Exclusion criteria
- Known with mental impairment (for example retrieved from medical record that the patient suffers from a syndrome with mental retardation such as Down*s syndrome), i.e. not capable of completing the questionnaires.
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 | NL46087.078.13 |