Clinical trial · Observational
Surviving Rectal Cancer at the Cost of a Colostomy International Validation of the Colostomy Impact Score
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The formation of a colostomy following surgery for rectal cancer changes body image, challenges patient practical skills and threatens quality of life. As the oncological results have improved over the last decades the number of survivors from rectal cancer who have to adjust to a cancer free life in their own homes is increasing. To enable the identification of the patients with stoma-related reduced health-related Quality of life (HRQoL) in a quick and reliable way we recently developed the Colostomy Impact Score (CI-score) comprising 7 items of stoma related factors with significant impact on HRQoL. The purpose of the present project is to perform an international validation of the CI-score and to demonstrate its applicability. The construct validity of the CI-score will be studied internationally on crosssectional cohorts of patients with permanent colostomy after abdominoperineal excision (APE) or Hartmann's procedure in Denmark, Sweden, Spain, the Netherlands, United Kingdom, Turkey, Brazil, Egypt, Russia, Lithuania, Israel, Portugal, South Africa, Australia and China. This will be done by testing the CI-score against five anchor questions stoma impact on HRQoL, the 5 Level version og the EuroQol measuer (EQ-5D-5L) and version 3.0 of the Quality of Life Questionnaire from the European Organisation for Research and Treatment of Cancer (EORTC QLQ C30 questionnaire v3.0). The impact of the challenges related to having a stoma may vary with different demographic, socioeconomic and cultural factors. Supplementary data on stoma care, demographics and socioeconomic status will be gathered to study the impact of patient-related factors and cultural differences on HRQoL in rectal cancer survivors with an ostomy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colostomy Stoma | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires on HRQoL and sociodemography | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (15)
- label
- Australia
- description
- Patients with a permanent colostomy after curative surgery for rectal cancer
- interventionNames
- Other: Questionnaires on HRQoL and sociodemography
- label
- Brazil
- description
- Patients with a permanent colostomy after curative surgery for rectal cancer
- interventionNames
- Other: Questionnaires on HRQoL and sociodemography
- label
- China
- description
- Patients with a permanent colostomy after curative surgery for rectal cancer
- interventionNames
- Other: Questionnaires on HRQoL and sociodemography
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Curative intended Hartmann's procedure or abdominal perineal excision \>12 months ago for carcinoma of the rectum * Permanent colostomy Exclusion Criteria: * Age \< 18 years * Recurrence of cancer * Mental dementia * Unable to understand the actual language
References
Publications (0)
Data not yet available