An observational study in Incisional Hernia, Parastomal Hernia and Ventral Hernia, sponsored by Line Marker. Enrolling by invitation at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Line Marker · Observational
The goal of this clinical trial called the VITAL study is to learn if surgery has a positive impact on the quality of life in patients with incisional or parastomal hernia. The main questions it aims to answer are:
Does surgery alleviate patients from their initial problem? Does new discomfort arise after surgery? Do the symptoms worsen, and does quality of life deteriorate in patients who are not offered surgery? The project will also look at time to surgery and postoperative complications. Researchers will send questionnaires to the patients to answer.
Participants will:
Answer the baseline questionnaire. Answer the follow-up questionnaires at 1 month, 3 months, 6 months, 1 year, and 3 years after surgery or after the baseline questionnaire has been completed for those patients being managed conservatively with observation
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 75 observational studies indexed under Incisional Hernia.
Browse Incisional Hernia studies →This is the only study on the registry with Line Marker as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients who are referred with a ventral hernia to the surgical outpatient clinic at Zealand University Hospital.
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:
Patients with incisional hernias who are either offered surgery or conservative treatment
Patients with parastomal hernias who are either offered surgery or conservative treatment
The questionnaire used is the Abdominal Hernia Q, which is specific to ventral hernias. Patients will receive the questionnaire at baseline and at 1, 3, 6, and 12 months after ventral hernia repair. If treated conservatively, the questionnaire will be administered at 1, 3, 6, and 12 months after completing the baseline questionnaire.
Also known as: Patient reported outcome
Change in quality of life after ventral hernia repair for pateints with incisional hernia
The patients will receive a questionnaire at baseline and at 1, 3, 6, 12, and 36 months of follow-up. The project will use the Abdominal Hernia-Q. It features both a pre- and postoperative form, including a total of 24 items with responses scored on a 4-point Likert scale. Patient responses will be averaged, producing a possible score range of 0 to 4.
Time frame: From enrollment to the end of follow-up at 36 months.
Quality of life in patient with incisional hernia
The patients will receive a questionnaire at baseline and at 1, 3, 6, 12, and 36 months of follow-up. The project will use the Abdominal Hernia-Q. It features both a pre- and postoperative form, including a total of 24 items with responses scored on a 4-point Likert scale. Patient responses will be averaged, producing a possible score range of 0 to 4.
Time frame: From enrollment to the end of follow-up at 36 months.
Quality of life in patients with parastomal hernia
The patients will receive a questionnaire at baseline and at 1, 3, 6, 12, and 36 months of follow-up. The project will use the Abdominal Hernia-Q. It features both a pre- and postoperative form, including a total of 24 items with responses scored on a 4-point Likert scale. Patient responses will be averaged, producing a possible score range of 0 to 4.
Time frame: From enrollment to the end of follow-up at 36 months.
Changes in quality of life after ventral hernia repair in patients with parastomal hernia
The patients will receive a questionnaire at baseline and at 1, 3, 6, 12, and 36 months of follow-up. The project will use the Abdominal Hernia-Q. It features both a pre- and postoperative form, including a total of 24 items with responses scored on a 4-point Likert scale. Patient responses will be averaged, producing a possible score range of 0 to 4.
Time frame: From enrollment to the end of follow-up at 36 months.
Time to surgery
Days or months from the indication of surgery being set to ventral hernia repair.
Time frame: From enrollment to the end of follow-up at 36 months.
Postoperative complications
Any adverse events or conditions that occur following a surgical procedure.
Time frame: From enrolment to the end of follow-up at 36 months
Risk of emergency surgery during the waiting time
Number of patients who are undergoing emergency surgery during the waiting time for planned surgery.
Time frame: From enrollment to the end of follow-up at 36 months
Plan to share: No — Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following the review and approval of a research proposal and Statistical Analysis Plan (SAP), along with the execution of a Data Sharing Agreement (DSA).
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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