An observational study in Parastomal Hernia and Colorectal Cancer (Diagnosis), sponsored by Region Skane. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Region Skane · Observational
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 135 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients surgically treated for colorectal cancer within Region Skåne resulting in a permanent end colostomy (abdominoperineal resection or Hartmann's procedure), who undergo routine oncological follow-up surveillance with computed tomography (CT) at 1 and 3 years postoperatively.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Routine thoracoabdominal CT scans performed at 1 and 3 years postoperatively as part of the standard colorectal cancer follow-up program.
Mean Difference in Total Colostomy Impact Score (CIS) at 3 Years
The mean difference in total Colostomy Impact Score (CIS) between patients with and without a radiologically confirmed parastomal hernia at the 3-year follow-up. The CIS is a validated questionnaire with a total score ranging from 0 to 38, where higher scores indicate worse quality of life/greater symptom burden (scores 0-9: minor impact, 10-38: major impact).
Time frame: 3 years post-surgery
Mean Difference in Total Colostomy Impact Score (CIS) at 1 Year
The mean difference in total Colostomy Impact Score (CIS) between patients with and without a radiologically confirmed parastomal hernia at the 1-year follow-up.
Time frame: 1 year post-surgery
Mean Difference in EQ-5D-5L Index Values at 1 Year
The mean difference in EQ-5D-5L index values between patients with and without a radiologically confirmed parastomal hernia at the 1-year follow-up. The index score ranges from 0 (representing death) to 1 (representing full health), with negative values for states worse than death; higher scores indicate better health-related quality of life.
Time frame: 1 year post-surgery
Longitudinal Change in Generic Quality of Life (EQ-5D-5L Index)
The longitudinal change in the EQ-5D-5L index value for the total cohort between the 1-year and 3-year follow-ups. The score ranges from 0 to 1, where higher scores indicate better health-related quality of life.
Time frame: From 1 year to 3 years post-surgery
Incidence of Parastomal Hernia on CT Scans
The incidence of parastomal hernia at 1 and 3 years post-stoma creation, diagnosed by standardized review of routine oncological follow-up CT scans.
Time frame: 1 year and 3 years post-surgery
Rate of Radiological Parastomal Hernia Progression
The rate of hernia progression between the 1-year and 3-year follow-ups, defined by new hernia development, increase in fascial defect size, or change in European Hernia Society (EHS) classification.
Time frame: From 1 year to 3 years post-surgery
Diagnostic Correlation Between Patient-Reported Suspicion and Radiological Hernia
The correlation between patient-reported suspicion of a hernia and radiologically confirmed parastomal hernia at the 1-year follow-up.
Time frame: 1 year post-surgery
Plan to share: No — Data cannot be shared publicly due to patient confidentiality, the Swedish Ethical Review Act, and GDPR regulations.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2030, 49 months later.
Of 528 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's planned 49 months is below that.
Counting every sponsor, half of 645 studies reached it within 51 months; a quarter within 27 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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