An interventional study of preoptimisation programme in Hernia, Hernia, Ventral and Hernia Incisional, sponsored by Umeå University. Recruiting at 5 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by Umeå University · Not applicable, Interventional, and Prevention
The study is a multicentre, single-blinded, randomised controlled trial. Ventral hernia patients with an aperture width between four and eight centimetres are randomised to either participation in a multimodal preoptimisation programme, including interventions to increase physical activity, promote weight loss, and optimise the treatment of comorbidities, or to surgery without structured preoptimisation. The primary endpoint is complications at three months postoperatively. During surgery, biopsies of skin, muscle, and fascia will be collected, along with pre- and postoperative blood samples, to analyse the molecular effects of preoptimisation, particularly in relation to collagen metabolism.
257 studies on the registry are indexed under Hernia; 37 are open to participants now.
This study's planned enrollment of 130 is above the median of 80 across 167 interventional studies indexed under Hernia.
Browse Hernia studies →Umeå University is the lead sponsor of 272 studies on the registry; 60 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group participates in a home-based, multimodal prehabilitation programme addressing physical inactivity, obesity, inadequate management of comorbidities, smoking, and alcohol consumption.
Procedure: preoptimisation programme
The control group will receive basic guidance on physical activity and weight management during the preoperative consultation.
The intervention group follows a home-based, multimodal prehabilitation programme targeting physical inactivity, obesity, comorbidities, smoking, and alcohol use. Designed to suit both rural and urban populations in northern Sweden, the programme lasts for a minimum of three months before surgery.
Complications at three months postoperatively
Incidence of surgical and medical (including anaesthetic) complications at 3 months postoperatively.
Time frame: 3 months postoperatively
Complications at twelve months postoperatively
Incidence of surgical and medical complications at 12 months postoperatively.
Time frame: 12 months postoperatively
Patient-reported pain
Patient-reported pain measured with Ventral Hernia Pain Questionnaire, VHPQ. Max score is 40 and minimum score is 0, a lower score indicates less abdominal wall pain.
Time frame: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.
Quality of life with EQ-5D
Quality of life assessed using the EuroQol 5-Dimensions questionnaire (EQ-5D index score). Max score is 1.0, which equals to perfect health and a lower score indicates lower quality of life with 0 is equivalent to death. Negative scores indicated health states considered worse than dead (e.g. severe disability).
Time frame: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.
Aesthetic outcome
Patient reported aestethic outcome measured with a Numerical Ratin Scale, NRS scale, range 1-10 where a higher score indicates better patient reported aesthetic outcome.
Time frame: Measured at clinical follow-upat 3 and 12 months postoperatively.
Recurrence rate
Recurrence of ventral hernia.
Time frame: Measured at clinical follow-up at 3 and 12 months postoperatively.
Change in physical activity
changes in physical activity measured with accelerometer for one week.
Time frame: meassured close to inclusion and within a few weeks preoperatively.
Weight
Weight measured i kg.
Time frame: Measured at inclusion, preoperatively, 3 and 12 months postoperatively.
Collagen metabolism
Difference between study groups in the expression levels of a panel of markers of collagen degradation and synthesis (including CHP, Collagen 1 and 4, MMP) in tissue samples taken from fascia, muscle and skin.
Time frame: Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.
Hba1c
Hba1c in bloodsamples
Time frame: at baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively.
Hernia aperature width
Hernia aperature width
Time frame: measured peroperatively and on preoperative ct-scan preinclusion or within a few weeks after inclusion
B-PETH
B-PETH
Time frame: at baseline, perioperatively and at follow up at 3 and 12 months postoperatively.
Rutine labarotory tests
Number of participants with abnormal routine laboratory tests results
Time frame: At baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively
Hyaluronan metabolism
Difference between study groups in the expression patterns and histological distribution of hyaluronan and hyaluronan metabolism-related factors (including CD44, TRAMM, and hyaluronidases) in tissue samples taken from fascia, muscle and skin.
Time frame: Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.
Plan to share: No
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