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Ventral Hernia Improvement of Treatment and Life

NCT06864377 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-03-21

No results posted yet for this study

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

  • Incisional Hernia
  • Parastomal Hernia
  • Ventral Hernia

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.

Sponsors & Collaborators

  • Aage og Johanne Louis-Hansens Fond

    collaborator OTHER

  • Line Marker

    lead OTHER

Principal Investigators

  • Frederik Helgstrand, DMSc · Zealand University Hospital, Køge

  • Line Marker, MD · Zealand University Hospital, Køge

  • Pernille D.K. Diasso, MD, Ph.d. · Zealand University Hospital, Køge

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-12-31
Completion
2027-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06864377 on ClinicalTrials.gov