Incisional HerniaVITALNCT06864377

Ventral Hernia Improvement of Treatment and Life

An observational study of Incisional Hernia and Parastomal Hernia, run by Line Marker at 1 site in Denmark.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Incisional Hernia, Parastomal Hernia, Ventral Hernia
What is being tested?: Quality of life questionnair
How many people: 300 participants
Where: 1 siteDenmark
Study dates: 1 Jan 2025to 31 Oct 2027
How long will I take part?: 3 Years
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

>18 years
Incisional hernia or parastomal hernia

Who cannot join

Can't understand or read Danish

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Denmark1 site

Department of surgery, Zealand University Hospital
Køge, 4600

Other trials in Denmark

About this study

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
Being tested: Quality of life questionnair
Keywords: Incisional hernia, Parastomal hernia, Quality of life, Patient-reported outcomes
Medical subject headings: Incisional Hernia, Hernia, Ventral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quality of life questionnairOther
Also called Patient reported outcome
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.

Study groups in NCT06864377
Study group	Role	What they receive
Patients with incisinal hernias		Patients with incisional hernias who are either offered surgery or conservative treatment
Patients with parastomal hernias		Patients with parastomal hernias who are either offered surgery or conservative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in quality of life after ventral hernia repair for pateints with incisional hernia
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.
Measured: From enrollment to the end of follow-up at 36 months.
Quality of life in patient with incisional hernia
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.
Measured: From enrollment to the end of follow-up at 36 months.
Quality of life in patients with parastomal hernia
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.
Measured: 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
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.
Measured: From enrollment to the end of follow-up at 36 months.

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202531 Oct 2027

First posted7 Mar 2025
Study start1 Jan 2025
Primary completion31 Dec 2026 (estimated)
Study completion31 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Incisional HerniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 300 participants (estimated)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT06864377
Sponsor's protocol ID: p-2024-17652
Acronym: VITAL
Status last verified: Mar 2025
First submitted: 3 Mar 2025
Last updated: 21 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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).

Publications

Liang MK, Holihan JL, Itani K, Alawadi ZM, Gonzalez JR, Askenasy EP, Ballecer C, Chong HS, Goldblatt MI, Greenberg JA, Harvin JA, Keith JN, Martindale RG, Orenstein S, Richmond B, Roth JS, Szotek P, Towfigh S, Tsuda S, Vaziri K, Berger DH. Ventral Hernia Management: Expert Consensus Guided by Systematic Review. Ann Surg. 2017 Jan;265(1):80-89. doi: 10.1097/SLA.0000000000001701.
PubMed 28009730
Pernar LIM, Pernar CH, Dieffenbach BV, Brooks DC, Smink DS, Tavakkoli A. What is the BMI threshold for open ventral hernia repair? Surg Endosc. 2017 Mar;31(3):1311-1317. doi: 10.1007/s00464-016-5113-5. Epub 2016 Jul 20.
PubMed 27440197
Huntington C, Gamble J, Blair L, Cox T, Prasad T, Lincourt A, Augenstein V, Heniford BT. Quantification of the Effect of Diabetes Mellitus on Ventral Hernia Repair: Results from Two National Registries. Am Surg. 2016 Aug;82(8):661-71.
PubMed 27657579
Borad NP, Merchant AM. The effect of smoking on surgical outcomes in ventral hernia repair: a propensity score matched analysis of the National Surgical Quality Improvement Program data. Hernia. 2017 Dec;21(6):855-867. doi: 10.1007/s10029-017-1664-1. Epub 2017 Sep 1.
PubMed 28864961
Parker SG, Mallett S, Quinn L, Wood CPJ, Boulton RW, Jamshaid S, Erotocritou M, Gowda S, Collier W, Plumb AAO, Windsor ACJ, Archer L, Halligan S. Identifying predictors of ventral hernia recurrence: systematic review and meta-analysis. BJS Open. 2021 Mar 5;5(2):zraa071. doi: 10.1093/bjsopen/zraa071.
PubMed 33839749
Henriksen NA, Bisgaard T, Andersen HF, Jorgensen LN, Helgstrand F. [Surgical treatment algorithm for ventral hernias]. Ugeskr Laeger. 2018 Sep 10;180(37):V02180096. Danish.
PubMed 30259832
Sando A, Rosen MJ, Heniford BT, Bisgaard T. Long-term patient-reported outcomes and quality of the evidence in ventral hernia mesh repair: a systematic review. Hernia. 2020 Aug;24(4):695-705. doi: 10.1007/s10029-020-02154-1. Epub 2020 Mar 9.
PubMed 32152807
Mohamud AA, Sando A, Helgstrand F, Bisgaard T. [Patient-reported outcome measures after ventral hernia surgery]. Ugeskr Laeger. 2021 Jan 4;183(1):V05200399. Danish.
PubMed 33491623
Friis-Andersen H, Bisgaard T. The Danish Inguinal Hernia database. Clin Epidemiol. 2016 Oct 25;8:521-524. doi: 10.2147/CLEP.S99512. eCollection 2016.
PubMed 27822094
Bisgaard T, Helgstrand F, Friis-Andersen H, Rosenberg J, Jørgensen LN, Pedersen KF, m.fl. Optimizing outcomes after hernia repair: scientific highlights from the Danish Hernia Database 2010-2020. Laparosc Surg. januar 2022;6:5-5.
Helgstrand F, Jorgensen LN. The Danish Ventral Hernia Database - a valuable tool for quality assessment and research. Clin Epidemiol. 2016 Oct 25;8:719-723. doi: 10.2147/CLEP.S99501. eCollection 2016.
PubMed 27822119
Bisgaard T, Kehlet H, Bay-Nielsen MB, Iversen MG, Wara P, Rosenberg J, Friis-Andersen HF, Jorgensen LN. Nationwide study of early outcomes after incisional hernia repair. Br J Surg. 2009 Dec;96(12):1452-7. doi: 10.1002/bjs.6728.
PubMed 19918863
Kokotovic D, Bisgaard T, Helgstrand F. Long-term Recurrence and Complications Associated With Elective Incisional Hernia Repair. JAMA. 2016 Oct 18;316(15):1575-1582. doi: 10.1001/jama.2016.15217.
PubMed 27750295
Manole TE, Daniel I, Alexandra B, Dan PN, Andronic O. Risk Factors for the Development of Parastomal Hernia: A Narrative Review. Saudi J Med Med Sci. 2023 Jul-Sep;11(3):187-192. doi: 10.4103/sjmms.sjmms_235_22. Epub 2023 Jul 15.
PubMed 37533654
Deerenberg EB, Henriksen NA, Antoniou GA, Antoniou SA, Bramer WM, Fischer JP, Fortelny RH, Gok H, Harris HW, Hope W, Horne CM, Jensen TK, Kockerling F, Kretschmer A, Lopez-Cano M, Malcher F, Shao JM, Slieker JC, de Smet GHJ, Stabilini C, Torkington J, Muysoms FE. Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies. Br J Surg. 2022 Nov 22;109(12):1239-1250. doi: 10.1093/bjs/znac302.
PubMed 36026550

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Incisional Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ventral Hernia Improvement of Treatment and Life
ClinicalTrials.gov ID: NCT06864377
Acronym / sponsor ID: VITAL / p-2024-17652
Conditions: Incisional Hernia, Parastomal Hernia, Ventral Hernia
Keywords: Incisional hernia, Parastomal hernia, Quality of life, Patient-reported outcomes
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 300 participants (estimated)
Lead sponsor: Line MarkerUniversity, hospital or other
Collaborators: Aage og Johanne Louis-Hansens Fond
Study start: 1 Jan 2025 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Oct 2027 (estimated)
First posted: 7 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants will:

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 2

Arm	Type	Receives
Patients with incisinal hernias	–	–Patients with incisional hernias who are either offered surgery or conservative treatment
Patients with parastomal hernias	–	–Patients with parastomal hernias who are either offered surgery or conservative treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who are referred with a ventral hernia to the surgical outpatient clinic at Zealand University Hospital.

Key inclusion criteria (2 listed)

>18 years
Incisional hernia or parastomal hernia

Key exclusion criteria (1 listed)

Can't understand or read Danish

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quality of life questionnairAlso: Patient reported outcomeThe 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	–

Primary outcome

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.
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.
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.
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.

3 secondary outcomes

Time to surgery
Time frame: 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
Risk of emergency surgery during the waiting time
Time frame: From enrollment to the end of follow-up at 36 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
Background: PubMed 28009730Liang MK, Holihan JL, Itani K, Alawadi ZM, Gonzalez JR, Askenasy EP, Ballecer C, Chong HS, Goldblatt MI, Greenberg JA, Harvin JA, Keith JN, Martindale RG, Orenstein S, Richmond B, Roth JS, Szotek P, Towfigh S, Tsuda S, Vaziri K, Berger DH. Ventral Hernia Management: Expert Consensus Guided by Systematic Review. Ann Surg. 2017 Jan;265(1):80-89. doi: 10.1097/SLA.0000000000001701.
Background: PubMed 27440197Pernar LIM, Pernar CH, Dieffenbach BV, Brooks DC, Smink DS, Tavakkoli A. What is the BMI threshold for open ventral hernia repair? Surg Endosc. 2017 Mar;31(3):1311-1317. doi: 10.1007/s00464-016-5113-5. Epub 2016 Jul 20.
Background: PubMed 27657579Huntington C, Gamble J, Blair L, Cox T, Prasad T, Lincourt A, Augenstein V, Heniford BT. Quantification of the Effect of Diabetes Mellitus on Ventral Hernia Repair: Results from Two National Registries. Am Surg. 2016 Aug;82(8):661-71.
Background: PubMed 28864961Borad NP, Merchant AM. The effect of smoking on surgical outcomes in ventral hernia repair: a propensity score matched analysis of the National Surgical Quality Improvement Program data. Hernia. 2017 Dec;21(6):855-867. doi: 10.1007/s10029-017-1664-1. Epub 2017 Sep 1.
Background: PubMed 33839749Parker SG, Mallett S, Quinn L, Wood CPJ, Boulton RW, Jamshaid S, Erotocritou M, Gowda S, Collier W, Plumb AAO, Windsor ACJ, Archer L, Halligan S. Identifying predictors of ventral hernia recurrence: systematic review and meta-analysis. BJS Open. 2021 Mar 5;5(2):zraa071. doi: 10.1093/bjsopen/zraa071.
Background: PubMed 30259832Henriksen NA, Bisgaard T, Andersen HF, Jorgensen LN, Helgstrand F. [Surgical treatment algorithm for ventral hernias]. Ugeskr Laeger. 2018 Sep 10;180(37):V02180096. Danish.
Background: PubMed 32152807Sando A, Rosen MJ, Heniford BT, Bisgaard T. Long-term patient-reported outcomes and quality of the evidence in ventral hernia mesh repair: a systematic review. Hernia. 2020 Aug;24(4):695-705. doi: 10.1007/s10029-020-02154-1. Epub 2020 Mar 9.
Background: PubMed 33491623Mohamud AA, Sando A, Helgstrand F, Bisgaard T. [Patient-reported outcome measures after ventral hernia surgery]. Ugeskr Laeger. 2021 Jan 4;183(1):V05200399. Danish.
Background: PubMed 27822094Friis-Andersen H, Bisgaard T. The Danish Inguinal Hernia database. Clin Epidemiol. 2016 Oct 25;8:521-524. doi: 10.2147/CLEP.S99512. eCollection 2016.
BackgroundBisgaard T, Helgstrand F, Friis-Andersen H, Rosenberg J, Jørgensen LN, Pedersen KF, m.fl. Optimizing outcomes after hernia repair: scientific highlights from the Danish Hernia Database 2010-2020. Laparosc Surg. januar 2022;6:5-5.
Background: PubMed 27822119Helgstrand F, Jorgensen LN. The Danish Ventral Hernia Database - a valuable tool for quality assessment and research. Clin Epidemiol. 2016 Oct 25;8:719-723. doi: 10.2147/CLEP.S99501. eCollection 2016.
Background: PubMed 19918863Bisgaard T, Kehlet H, Bay-Nielsen MB, Iversen MG, Wara P, Rosenberg J, Friis-Andersen HF, Jorgensen LN. Nationwide study of early outcomes after incisional hernia repair. Br J Surg. 2009 Dec;96(12):1452-7. doi: 10.1002/bjs.6728.
Annual Report 2023 from the Danish Hernia databaseLink provided by the sponsor.
Individual participant dataSharing planned: No. 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).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Frederik Helgstrand, DMSc study director

Zealand University Hospital, Køge

Line Marker, MD principal investigator

Zealand University Hospital, Køge

Pernille D.K. Diasso, MD, Ph.d. study director

Zealand University Hospital, Køge

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Incisional Hernia and Parastomal Hernia, run by Line Marker at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06864377, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.