Ventral Hernia Improvement of Treatment and Life

NCT06864377 | Enrolling By Invitation

• 1 other identifier: p-2024-17652
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Incisional Hernia; Parastomal Hernia; Ventral Hernia

Keywords

Incisional hernia; Parastomal hernia; Quality of life; Patient-reported outcomes

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

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

Secondary Outcomes (3)

• Time to surgery

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

• Postoperative complications

  From enrolment to the end of follow-up at 36 months

• Risk of emergency surgery during the waiting time

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

Study Arms (2)

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

Interventions

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.

Also known as: Patient reported outcome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \>18 years
• Incisional hernia or parastomal hernia

You may not qualify if:

• \- Can't understand or read Danish

Sponsors & Collaborators

• Line Marker: lead
• Aage og Johanne Louis-Hansens Fond: collaborator

Study Sites (1)

Department of surgery, Zealand University Hospital

Køge, 4600, Denmark

Location

Related Publications (16)

• 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.

  PMID: 28009730 BACKGROUND

• 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.

  PMID: 27440197 BACKGROUND

• 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.

  PMID: 27657579 BACKGROUND

• 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.

  PMID: 28864961 BACKGROUND

• 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.

  PMID: 33839749 BACKGROUND

• 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.

  PMID: 30259832 BACKGROUND

• 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.

  PMID: 32152807 BACKGROUND

• 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.

  PMID: 33491623 BACKGROUND

• 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.

  PMID: 27822094 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27822119 BACKGROUND

• 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.

  PMID: 19918863 BACKGROUND

• 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.

  PMID: 27750295 BACKGROUND

• 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.

  PMID: 37533654 BACKGROUND

• 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.

  PMID: 36026550 BACKGROUND

• Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9.

  PMID: 21904861 BACKGROUND

Related Links

• Annual Report 2023 from the Danish Hernia database

MeSH Terms

Conditions

Incisional Hernia; Hernia, Ventral

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Hernia, Abdominal

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Frederik Helgstrand, DMSc

  Zealand University Hospital, Køge

  STUDY DIRECTOR

• Line Marker, MD

  Zealand University Hospital, Køge

  PRINCIPAL INVESTIGATOR

• Pernille D.K. Diasso, MD, Ph.d.

  Zealand University Hospital, Køge

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)