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ENROLLING BY INVITATION
NCT06864377

Ventral Hernia Improvement of Treatment and Life

Sponsor: Line Marker

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2025-01-01

Completion Date

2027-10-31

Last Updated

2025-03-21

Healthy Volunteers

No

Interventions

OTHER

Quality of life questionnair

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.

Locations (1)

Department of surgery, Zealand University Hospital

Køge, Denmark