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Enrolling by Invitation

NCT Number: NCT06864377

Ventral Hernia Improvement of Treatment and Life

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

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Key information

Conditions

Incisional Hernia Hernia Hernia, Abdominal Hernia, Ventral Parastomal Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Ventral Hernia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of surgery, Zealand University Hospital

Køge, 4600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years
  • Incisional hernia or parastomal hernia

Exclusion criteria

  • Can't understand or read Danish

Treatment and study plan

Quality of life questionnair

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Line Marker

Other

Collaborators

  • Aage og Johanne Louis-Hansens Fond

Registry information

Acronym: VITAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 7, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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