Parastomal HerniaNCT07909148
Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life
An observational study of Parastomal Hernia and Colorectal Cancer (Diagnosis), run by Region Skane at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia, Colorectal Cancer (Diagnosis)
- What is being tested?
- Routine Surveillance Computed Tomography (CT)
- How many people
- 135 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2026to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- Severe cognitive impairment or language barriers precluding the completion of the QoL questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Region Skåne, Skåne University Hospital
Malmö, Skåne County, 21428
Ali Al Mukhtar, MD, +46707182726, ali.almukhtar@skane.se
About this study
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.
- Conditions
- Parastomal Hernia, Colorectal Cancer (Diagnosis)
- Being tested
- Routine Surveillance Computed Tomography (CT)
- Keywords
- End Colostomy, Colostomy Impact Score, EQ-5D-5L, Quality of Life, Stoma care
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Surveillance Computed Tomography (CT)Diagnostic test
Routine thoracoabdominal CT scans performed at 1 and 3 years postoperatively as part of the standard colorectal cancer follow-up program.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 years post-surgery
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Marie-Louise Lydrup, Region Skane
- Investigators
- Marie-Louise Lydrup, MD, Assoc. Prof., Principal investigator, Region Skåne and the Department of Clinical Sciences, Faculty of Medicine, Lund University, Malmö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909148
- Sponsor's protocol ID
- Dnr 2026-03856-01
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data cannot be shared publicly due to patient confidentiality, the Swedish Ethical Review Act, and GDPR regulations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT07909148
- Acronym / sponsor ID
- Dnr 2026-03856-01
- Conditions
- Parastomal Hernia, Colorectal Cancer (Diagnosis)
- Keywords
- End Colostomy, Colostomy Impact Score, EQ-5D-5L, Quality of Life, Stoma care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Severe cognitive impairment or language barriers precluding the completion of the QoL questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
Mean Difference in Total Colostomy Impact Score (CIS) at 3 Years
Time frame: 3 years post-surgery
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).
6 secondary outcomes
Mean Difference in Total Colostomy Impact Score (CIS) at 1 Year
Time frame: 1 year post-surgery
Mean Difference in EQ-5D-5L Index Values at 1 Year
Time frame: 1 year post-surgery
Longitudinal Change in Generic Quality of Life (EQ-5D-5L Index)
Time frame: From 1 year to 3 years post-surgery
Incidence of Parastomal Hernia on CT Scans
Time frame: 1 year and 3 years post-surgery
Rate of Radiological Parastomal Hernia Progression
Time frame: From 1 year to 3 years post-surgery
Diagnostic Correlation Between Patient-Reported Suspicion and Radiological Hernia
Time frame: 1 year post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. Data cannot be shared publicly due to patient confidentiality, the Swedish Ethical Review Act, and GDPR regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Louise Lydrup, MD, Assoc. Prof. principal investigator
Region Skåne and the Department of Clinical Sciences, Faculty of Medicine, Lund University, Malmö, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parastomal Hernia and Colorectal Cancer (Diagnosis), run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Al Mukhtar, MD (+46707182726, ali.almukhtar@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference in Total Colostomy Impact Score (CIS) at 3 Years (time frame: 3 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.