Ventral Hernia Improvement of Treatment and Life (VITAL)

March 18, 2025 updated by: Line Marker

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Department of Surgery, Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are referred with a ventral hernia to the surgical outpatient clinic at Zealand University Hospital.

Description

Inclusion Criteria:

  • >18 years
  • Incisional hernia or parastomal hernia

Exclusion Criteria:

- Can't understand or read Danish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with incisinal hernias
Patients with incisional hernias who are either offered surgery or conservative treatment
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.
Other Names:
  • Patient reported outcome
Patients with parastomal hernias
Patients with parastomal hernias who are either offered surgery or conservative treatment
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.
Other Names:
  • Patient reported outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life after ventral hernia repair for pateints with incisional hernia
Time Frame: From enrollment to the end of follow-up at 36 months.
The patients will receive a questionnaire at baseline and at 1, 3, 6, 12, and 36 months of follow-up. The project will use the Abdominal Hernia-Q. It features both a pre- and postoperative form, including a total of 24 items with responses scored on a 4-point Likert scale. Patient responses will be averaged, producing a possible score range of 0 to 4.
From enrollment to the end of follow-up at 36 months.
Quality of life in patient with incisional hernia
Time Frame: From enrollment to the end of follow-up at 36 months.
The patients will receive a questionnaire at baseline and at 1, 3, 6, 12, and 36 months of follow-up. The project will use the Abdominal Hernia-Q. It features both a pre- and postoperative form, including a total of 24 items with responses scored on a 4-point Likert scale. Patient responses will be averaged, producing a possible score range of 0 to 4.
From enrollment to the end of follow-up at 36 months.
Quality of life in patients with parastomal hernia
Time Frame: From enrollment to the end of follow-up at 36 months.
The patients will receive a questionnaire at baseline and at 1, 3, 6, 12, and 36 months of follow-up. The project will use the Abdominal Hernia-Q. It features both a pre- and postoperative form, including a total of 24 items with responses scored on a 4-point Likert scale. Patient responses will be averaged, producing a possible score range of 0 to 4.
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
Time Frame: From enrollment to the end of follow-up at 36 months.
The patients will receive a questionnaire at baseline and at 1, 3, 6, 12, and 36 months of follow-up. The project will use the Abdominal Hernia-Q. It features both a pre- and postoperative form, including a total of 24 items with responses scored on a 4-point Likert scale. Patient responses will be averaged, producing a possible score range of 0 to 4.
From enrollment to the end of follow-up at 36 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to surgery
Time Frame: From enrollment to the end of follow-up at 36 months.
Days or months from the indication of surgery being set to ventral hernia repair.
From enrollment to the end of follow-up at 36 months.
Postoperative complications
Time Frame: From enrolment to the end of follow-up at 36 months
Any adverse events or conditions that occur following a surgical procedure.
From enrolment to the end of follow-up at 36 months
Risk of emergency surgery during the waiting time
Time Frame: From enrollment to the end of follow-up at 36 months
Number of patients who are undergoing emergency surgery during the waiting time for planned surgery.
From enrollment to the end of follow-up at 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Line Marker

Collaborators

Aage og Johanne Louis-Hansens Fond

Investigators

  • Study Director: Frederik Helgstrand, DMSc, Zealand University Hospital, Køge
  • Principal Investigator: Line Marker, MD, Zealand University Hospital, Køge
  • Study Director: Pernille D.K. Diasso, MD, Ph.d., Zealand University Hospital, Køge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • p-2024-17652

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following the review and approval of a research proposal and Statistical Analysis Plan (SAP), along with the execution of a Data Sharing Agreement (DSA).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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