Menu
Enrolling by invitation NCT06864377

Ventral Hernia Improvement of Treatment and Life

— Observational Incisional Hernia Parastomal Hernia Ventral Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Quality of life questionnair.
Who it may be relevant to
Registry conditions: Incisional Hernia, Parastomal Hernia, Ventral Hernia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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.

Primary outcome measures

  • 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.]
  • Quality of life in patient with incisional hernia [Time frame: 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.]
  • 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.]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Inclusion criteria

  • >18 years
  • Incisional hernia or parastomal hernia

Exclusion criteria

\- Can't understand or read Danish

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Department of surgery, Zealand University Hospital — Køge

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 33491623

Identifiers

NCT: NCT06864377 · p-2024-17652

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗