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Trials / Enrolling By Invitation

Enrolling By InvitationNCT06864377

Ventral Hernia Improvement of Treatment and Life

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Line Marker · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
OTHERQuality of life questionnairThe 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.

Timeline

Start date
2025-01-01
Primary completion
2026-12-31
Completion
2027-10-31
First posted
2025-03-07
Last updated
2025-03-21

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT06864377. Inclusion in this directory is not an endorsement.