Clinical trial Recruiting at 1 site Observational Ages 18 and up

Parastomal Hernia After Colorectal Cancer Surgery: Do Radiology Findings Match Quality of Life

Official title: Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life

Run by Region Skane · NCT07909148 · Data updated 2026-11-12

We’re testing how often parastomal hernias appear and change on CT scans after colorectal cancer surgery with a permanent end colostomy, and whether these findings relate to patients’ quality of life.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment135 (estimated)
SponsorRegion Skane
Academic / other
Locations1 site (Malmö, Skåne County)
StatusRecruiting
StartedNovember 2026
Main results expectedDecember 2030
Study endsDecember 2030
Registry record updatedNovember 2, 2026
Trial IDNCT07909148 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with a prior colorectal cancer surgery resulting in a permanent end colostomy, enrolled in Region Skåne, and scheduled for routine CT surveillance at 1 and/or 3 years postoperatively who can complete Swedish QoL questionnaires.

Probably not a fit

Patients without a detectable or progression-prone parastomal hernia or those unable to complete QoL questionnaires may derive limited benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, longitudinal observational study of 135 patients in Region Skåne who had a permanent end colostomy for colorectal cancer. Participants will have routine CT scans at 1 and 3 years postoperatively, which will be reviewed to classify parastomal hernias by the European Hernia Society system and to track anatomical progression. At the same time, patients will answer validated stoma- and generic-quality of life questionnaires to see how imaging-detected hernias correspond to symptom burden and overall well-being. The study uses standard surveillance imaging and patient-reported outcomes to explore links between radiologic findings and QoL.

Why it matters

Potential benefit: If the study shows a clear link between CT-detected hernias and QoL, it could inform follow-up practices and patient counseling.

How similar studies have gone: Previous work in this area has established methods for classifying parastomal hernias and using QoL measures, but longitudinal links to QoL are still being explored.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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).

Exclusion Criteria:

* Severe cognitive impairment or language barriers precluding the completion of the QoL questionnaires.

Where it's running

  • Region Skåne, Skåne University Hospital
    Malmö, Skåne County, Sweden
    Recruiting

Study contacts

  • Principal investigator: Marie-Louise Lydrup, MD, Assoc. Prof. — Region Skåne and the Department of Clinical Sciences, Faculty of Medicine, Lund University, Malmö, Sweden
  • Study coordinator: Ali Al Mukhtar, MD
  • Email: ali.almukhtar@skane.se
  • Phone: +46707182726

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.