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RECRUITING
NCT07909148

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

Sponsor: Region Skane

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

135

Start Date

2026-11

Completion Date

2030-12

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Routine Surveillance Computed Tomography (CT)

Routine thoracoabdominal CT scans performed at 1 and 3 years postoperatively as part of the standard colorectal cancer follow-up program.

Locations (1)

Region Skåne, Skåne University Hospital

Malmö, Skåne County, Sweden