K59.2 S14 S24 S34 T09
Conditions
Interventions
Group 1: End stoma. Monocentric retrospective observational group of adult patients with spinal cord injury who received an end intestinal stoma at the spinal cord injury center / BG Klinikum Boberg d
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age = 18 years at the time of stoma creation Confirmed spinal cord injury (traumatic or non-traumatic) Creation of a permanent or temporary intestinal stoma (colostomy or ileostomy) at the Spinal Cord Injury Center / BG Klinikum Boberg during the defined observation period from 2015-01-01 to 2025-12-31 Complete operative documentation and available baseline data, in particular level of lesion and AIS classification (American Spinal Injury Association Impairment Scale), where available
Exclusion criteria
Exclusion criteria: Missing or severely incomplete medical records Deceased at the time of a potentially planned survey (applies to the questionnaire component of the study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exploratory primary endpoints are differences between end stoma and loop stoma with regard to: Health-related quality of life (HRQoL) What: health-related quality of life after stoma creation. When: assessed once during the prospective follow-up survey in living and contactable patients; current status after stoma creation. How: standardized patient questionnaire using the SF-36 (Short Form-36 Health Survey). Stoma-specific / bowel-related quality of life What: stoma-related and bowel-related quality of life and difficulties associated with bowel management. When: assessed once during the prospective follow-up survey in living and contactable patients; current status after stoma creation. How: standardized patient questionnaire using SCI-QoL Bowel Management Difficulties (Spinal Cord Injury – Quality of Life, Bowel Management Difficulties), Stoma-QoL (Stoma Quality of Life Questionnaire), and the Burwood Questionnaire. Rate of stoma-associated complications What: occurrence of stoma-associated complications such as parastomal hernia, prolapse, stenosis, skin complications, ileus/obstruction, dehydration, or diversion colitis. When: retrospectively assessed over the entire observation period from stoma creation until the end of documented follow-up. How: review of routine clinical documentation (operative reports, discharge letters, rehabilitation reports, inpatient progress notes, and outpatient follow-up reports). Rate of stoma-associated rehospitalizations What: number and occurrence of stoma-associated rehospitalizations. When: retrospectively assessed over the entire documented follow-up period after stoma creation. How: review of medical records / routine clinical documentation. Need for revision surgery or stoma reversal What: revision surgery, stoma reversal, reconnection, or conversion of the stoma. When: retrospectively assessed over the entire documented follow-up period after stoma creation. How: review of operative reports and clinical follow-up document | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints Time expenditure for bowel management / stoma care What: time required for bowel management or stoma care before and after stoma creation. When: assessed once during the prospective follow-up survey; retrospective self-report for the period before stoma creation and current status after stoma creation. How: standardized patient survey (study-specific items within the questionnaire set; reported in minutes/day or hours/week, supplemented by stoma-specific questionnaires such as Stoma-QoL). Level of independence in bowel/stoma care What: independence in bowel management / stoma care (independent, partially assisted, fully assisted). When: assessed once during the prospective follow-up survey for the current status after stoma creation. How: standardized patient questionnaire with study-specific items. Neurogenic bowel dysfunction / bowel symptom burden What: severity of neurogenic bowel dysfunction and bowel-related symptom burden. When: assessed once during the prospective follow-up survey for the current status. How: NBD score (Neurogenic Bowel Dysfunction score) and additionally SCI-QoL Bowel Management Difficulties. Impact of timing of stoma creation on outcomes What: association of time from spinal cord injury to stoma creation and duration of insufficient bowel management with clinical and functional outcomes. When: retrospectively across the full observation period; additionally assessed in the one-time survey subgroup. How: linkage of routine clinical data with patient-reported questionnaire data. Stoma location and configuration What: differences in stoma location and configuration between groups. When: at the time of stoma creation. How: review of operative reports and routine clinical documentation. | — |
Countries
Germany
Contacts
Public ContactValerie Isabel Nottberg
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed