Improving Decisions and Outcomes in Parastomal Hernia Surgery
ConditionParastomal Hernia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErling Oma
About this trial
The goal of this observational study is to help improve decisions about planned surgery for parastomal hernia and understand the results of treatment. A parastomal hernia is a bulge that develops around a stoma, an opening in the abdomen created during surgery to allow bowel contents to pass into a bag. These hernias can cause discomfort, problems with stoma care, and reduced quality of life. Surgery may help, but it also carries risks, and the hernia may return.
The study will include approximately 250 patients assessed for parastomal hernia at Bispebjerg Hospital in Denmark. It will include both patients who undergo planned hernia surgery and patients who are managed without surgery.
The main questions are:
What are the short- and long-term results of planned parastomal hernia surgery, including complications, hospital readmissions, further operations, return of the hernia, and quality of life?
How often do patients who are initially not offered planned surgery need emergency hospital care or emergency surgery?
Which patient characteristics, symptoms, and hernia features are associated with treatment decisions and outcomes?
How does quality of life change over time in patients managed with and without surgery?
Participants will receive their usual care. Decisions about treatment will be made by patients and their clinical team independently of study participation. The study does not assign treatments or require additional invasive examinations.
Researchers will collect information from routine clinical assessments, imaging, medical records, and questionnaires. Participants will complete two questionnaires about stoma-related quality of life and general health, called Stoma-QOL and EQ-5D-5L, when they join the study and at subsequent outpatient assessments.
Participants will also be invited to complete the questionnaires at home through secure digital mail. Patients who have not undergone hernia surgery will receive annual invitations starting one year after joining the study. Patients who undergo planned hernia surgery will receive invitations after surgery and annually thereafter. This allows researchers to follow quality of life over time in both groups.
Participants will be followed for up to five years from joining the study. The findings may help clinicians and patients make better-informed decisions about whether to proceed with planned parastomal hernia surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Parastomal hernia confirmed by clinical assessment and imaging.
Assessed in the specialist stoma outpatient clinic at Abdominalcenter K, Bispebjerg Hospital.
Able to understand the oral and written participant information.
Provides written informed consent.
Disqualifiers
Diagnosis of parastomal hernia ruled out.
Unwilling or unable to provide informed consent.
Trial population
Patients assessed in the specialist stoma outpatient clinic at Abdominalcenter K, Bispebjerg Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 2 trial groupsGroup A: non-operative management
Group B: operative management
Trial outcomes
Primary outcomes
1
Rate of hernia recurrence
hernia recurrence following elective parastomal hernia repair
Time frame
5 yearsSecondary outcomes
1
Rate of emergency presentations
acute hernia-related complications requiring emergency care +/- emergency surgery
Time frame
5 years2
Changes in stoma related quality of life
Stoma related quality of life changes over time for both patients treated conservatively and with surgery. Assessed with the stoma-related quality of life questionnare Stoma Quality of Life questionnaire (Stoma-QOL) at first visit, 3 months postoperatively for patients who undergo elective parastomal hernia repair, and subsequently once a year until 5 years for all included patients. Stoma-QOL: A 20-item, stoma-specific patient-reported outcome measure assessing quality of life in patients with a colostomy or ileostomy. The total score ranges from 0 to 100, with higher scores indicating better stoma-related quality of life.
Time frame
5 years3
changes in general quality of life
Quality of life changes over time for both patients treated conservatively and with surgery. Assessed with the quality of life questionnare EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at first visit, 3 months postoperatively for patients who undergo elective parastomal hernia repair, and subsequently once a year until 5 years for all included patients. EQ-5D-5L: A generic patient-reported measure of health-related quality of life assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels of severity. Using the Danish EQ-5D-5L value set, responses are converted into an index value ranging from -0.757 to 1.000, where higher values indicate better health-related quality of life and 1.000 represents full health. The instrument also includes the EQ Visual Analogue Scale (EQ VAS), ranging from 0 (worst health imaginable) to 100 (best health imaginable).
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Erling Oma
Lead sponsor
Bispebjerg Hospital
Sponsor institution
Source ClinicalTrials.gov
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