anorectal malformation Hirschsprung's disease sacrococcygeal teratoma
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed