By InvitationNot Applicable

Ventral Hernia Improvement of Treatment and Life

Denmark300 participantsStarted 2025-01-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \>18 years * Incisional hernia or parastomal hernia Exclusion Criteria: \- Can't understand or read Danish

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Quality of life in patient with incisional hernia

Timeframe: From enrollment to the end of follow-up at 36 months.

Quality of life in patients with parastomal hernia

Timeframe: 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

Timeframe: From enrollment to the end of follow-up at 36 months.

Trial details

NCT IDNCT06864377

SponsorLine Marker

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Incisional Hernia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \>18 years * Incisional hernia or parastomal hernia Exclusion Criteria: \- Can't understand or read Danish

What they're measuring

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.

Quality of life in patient with incisional hernia

Timeframe: From enrollment to the end of follow-up at 36 months.

Quality of life in patients with parastomal hernia

Timeframe: 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

Timeframe: From enrollment to the end of follow-up at 36 months.