K59.2 S14 S24 S34
Conditions
Interventions
Group 1: Prospective observation of patients before and after elective stoma formation. Adult patients with spinal cord injury and planned elective intestinal stoma formation for treatment of neurogen
additionally Stoma-QoL after stoma formation at T1 and T2). In addition, study-specific items are collected on time required for bowel/stoma management, level of independence, care support needs, rest
Sponsors
Universistätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age = 18 years Confirmed spinal cord injury (traumatic or non-traumatic) Planned elective creation of an intestinal stoma (colostomy or ileostomy) for treatment of neurogenic bowel dysfunction Ability to participate in questionnaire assessments (written and/or oral) Capacity to consent and written informed consent for study participation
Exclusion criteria
Exclusion criteria: Emergency stoma formation (e.g. perforation, acute ischemia, tumor obstruction) without primary indication of neurogenic bowel dysfunction Severe cognitive impairment preventing valid completion of the questionnaires Insufficient German language skills to safely complete the questionnaires Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in stool-specific quality of life between T0 and T2. What: change (?) in the FLQAI total score (Fragebogen zur Lebensqualität bei Analinkontinenz; German version of the Fecal Incontinence Quality of Life Scale, FIQLS). A higher score indicates better stool-specific quality of life. When: T0 = within 14 days before planned elective stoma formation; T2 = approximately 12 months (± 8 weeks) after stoma formation. How: standardized patient-reported assessment using the FLQAI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in neurogenic bowel dysfunction What: change (?) in the NBD score (Neurogenic Bowel Dysfunction Score). When: T0 to T2; the protocol additionally specifies longitudinal analyses from T0 to T1/T2. How: standardized patient-reported assessment using the NBD score. Change in general health-related quality of life What: change (?) in the SF-36 total score and SF-36 subscales (Short Form-36 Health Survey). When: T0 to T2; additionally assessed longitudinally from T0 to T1/T2. How: standardized patient-reported assessment using the SF-36. Change in SCI-specific quality of life What: change in SCI-QoL (Spinal Cord Injury – Quality of Life). When: T0 to T1/T2. How: standardized patient-reported assessment using SCI-QoL. Change in stoma-specific quality of life after stoma formation What: change in Stoma-QoL (Stoma Quality of Life Questionnaire). When: T1 = approximately 3 months (± 4 weeks) after stoma formation and T2 = approximately 12 months (± 8 weeks) after stoma formation. How: standardized patient-reported assessment using Stoma-QoL; applied only after stoma formation. Change in time required for bowel/stoma management What: change in time expenditure measured in hours per week. When: T0 to T1/T2; in the endpoint set, especially T0 to T2. How: study-specific patient-reported assessment. Change in autonomy and independence in care What: change in the degree of independence in bowel/stoma care (independent / partially assisted / fully assisted) and change in the proportion of fully independent patients. When: T0 to T1/T2; in the endpoint set, especially T0 vs. T2. How: study-specific patient-reported assessment. Change in care support requirements What: change in care hours per week specifically related to bowel/stoma care. When: T0 to T1/T2; in the endpoint set, especially T0 to T2. How: study-specific patient-reported assessment. Change in additional patient-reported burden parameters What: change in VAS scores (visual analogue | — |
Countries
Germany
Contacts
Public ContactValerie Isabel Nottberg
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed