Clinical trial NCT06864377: Ventral Hernia Improvement of Treatment and Life
Official title: Ventral Hernia Improvement of Treatment and Life
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Incisional Hernia
Parastomal Hernia
Ventral Hernia
Keywords: Incisional hernia
Parastomal hernia
Quality of life
Patient-reported outcomes
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Aage og Johanne Louis-Hansens Fond
First posted: 2025-03-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are referred with a ventral hernia to the surgical outpatient clinic at Zealand University Hospital.

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* \>18 years
* Incisional hernia or parastomal hernia

Exclusion Criteria:

- Can't understand or read Danish

Primary outcomes:
measure: Change in quality of life after ventral hernia repair for pateints with incisional hernia
timeFrame: From enrollment to the end of follow-up at 36 months.
measure: Quality of life in patient with incisional hernia
timeFrame: From enrollment to the end of follow-up at 36 months.
measure: Quality of life in patients with parastomal hernia
timeFrame: From enrollment to the end of follow-up at 36 months.
measure: Changes in quality of life after ventral hernia repair in patients with parastomal hernia
timeFrame: From enrollment to the end of follow-up at 36 months.
Secondary outcomes:
measure: Time to surgery
timeFrame: From enrollment to the end of follow-up at 36 months.
measure: Postoperative complications
timeFrame: From enrolment to the end of follow-up at 36 months
measure: Risk of emergency surgery during the waiting time
timeFrame: From enrollment to the end of follow-up at 36 months
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Department of surgery, Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital, Køge
name: Frederik Helgstrand, DMSc
role: STUDY_DIRECTOR
affiliation: Zealand University Hospital, Køge
name: Line Marker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zealand University Hospital, Køge
name: Pernille D.K. Diasso, MD, Ph.d.
role: STUDY_DIRECTOR
References:
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