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Recruiting NCT07909148

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

Conditions: Parastomal Hernia, Colorectal Cancer (Diagnosis)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 135
Sponsor: Region Skane

Location: Region Skåne, Skåne University Hospital Malmö Skåne County

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.

Eligibility 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07909148). StuddyBuddy aggregates publicly available trial information.