Incisional Hernia, Parastomal Hernia, Ventral Hernia
Conditions
Keywords
Incisional hernia, Parastomal hernia, Quality of life, Patient-reported outcomes
Brief 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
Interventions
OTHERQuality 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
Aage og Johanne Louis-Hansens Fond
Line Marker
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years * Incisional hernia or parastomal hernia
Exclusion criteria
\- Can't understand or read Danish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life after ventral hernia repair for pateints with incisional hernia | 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. |
| Quality of life in patient with incisional hernia | 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. |
| Quality of life in patients with parastomal hernia | 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. |
| Changes in quality of life after ventral hernia repair in patients with parastomal hernia | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | From enrolment to the end of follow-up at 36 months | Any adverse events or conditions that occur following a surgical procedure. |
| Risk of emergency surgery during the waiting time | 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. |
| Time to surgery | 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. |
Countries
Denmark
Outcome results
None listed