Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
300 participants
OBSERVATIONAL
2025-01-01
2027-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with incisinal hernias
Patients with incisional hernias who are either offered surgery or conservative treatment
No interventions assigned to this group
Patients with parastomal hernias
Patients with parastomal hernias who are either offered surgery or conservative treatment
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Incisional hernia or parastomal hernia
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Aage og Johanne Louis-Hansens Fond
OTHER
Line Marker
OTHER
Responsible Party
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Line Marker
Principal Investigator
Principal Investigators
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Frederik Helgstrand, DMSc
Role: STUDY_DIRECTOR
Zealand University Hospital, Køge
Line Marker, MD
Role: PRINCIPAL_INVESTIGATOR
Zealand University Hospital, Køge
Pernille D.K. Diasso, MD, Ph.d.
Role: STUDY_DIRECTOR
Zealand University Hospital, Køge
Locations
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Department of surgery, Zealand University Hospital
Køge, , Denmark
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Annual Report 2023 from the Danish Hernia database
Other Identifiers
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p-2024-17652
Identifier Type: -
Identifier Source: org_study_id
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