NCT07909148Recruiting
Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This prospective, longitudinal observational cohort study aims to investigate the radiological incidence, anatomical progression, and impact on quality of life (QoL) of parastomal hernia (PH) in patients operated on for colorectal cancer with a permanent end colostomy (abdominoperineal resection or Hartmann's procedure). A total of 135 patients within Region Skane will be followed at 1 and 3 years postoperatively in conjunction with their routine oncological follow-up computed tomography (CT) scans. The CT images will undergo standardized, independent review to classify parastomal hernias according to the European Hernia Society (EHS) classification and to assess anatomical progression over time. Simultaneously, participants will complete validated stoma-specific (Colostomy Impact Score, CIS) and generic (EQ-5D-5L) quality of life questionnaires to evaluate the clinical symptom burden associated with radiologically detected parastomal hernias.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 135 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2030
- Lead sponsor
- Region Skane
- Diseases
- Colorectal cancer
- NCT number
- NCT07909148
What you commit to
- Study type: Observational
- Planned participants: 135
- From Nov 2026 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe cognitive impairment or language barriers precluding the completion of the QoL questionnaires.
Who the study is looking for
- Age 18 years or older at the time of enrollment.
- Previous surgical resection for colorectal cancer resulting in a permanent end colostomy (abdominoperineal resection \[APR\] or Hartmann's procedure) performed within Region Skåne.
- Scheduled for routine oncological surveillance with thoracoabdominal computed tomography (CT) at 1 and/or 3 years postoperatively according to national clinical guidelines.
- Ability to provide written informed consent and completing Swedish self-administered questionnaires (Colostomy Impact Score and EQ-5D-5L).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Skåne, Skåne University Hospital Coordinator of this site? Confirm its status | Malmö | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.