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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
130
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.
Gällivare hospital
Gällivare, Norrbotten County, Sweden
RECRUITINGSunderby Hospital
Luleå, Norrbotten County, Sweden
RECRUITINGLycksele Hospital
Lycksele, Västerbotten County, Sweden
NOT_YET_RECRUITINGSkellefteå Hospital
Skellefteå, Västerbotten County, Sweden
NOT_YET_RECRUITINGUmeå University Hospital
Umeå, Västerbotten County, Sweden
RECRUITINGComplications 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.
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