Hernia, Hernia Incisional, Hernia, Umbilical, Hernia, Ventral
Conditions
Keywords
preoptimisation, prehabilitation
Brief summary
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.
Interventions
PROCEDUREpreoptimisation programme
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.
Sponsors
Region Norrbotten
Region Västerbotten
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The surgeon responsible for the follow-up assessments at 3 and 12 months postoperatively will be blinded to the participant's allocation to either the intervention or the control group.
Intervention model description
This study is a prospective, single-blinded, multicentre, randomised, controlled superiority trial employing a parallel-group design with an allocation ratio of 1:1.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a ventral hernia with a defect width of at least 4 cm. * Symptom burden related to the hernia sufficient to justify surgical intervention. * Age ≥ 18 years.
Exclusion criteria
* Expected survival of less than three years. * Inability to comprehend oral and written information or to provide informed consent. * Acute complication of the hernia requiring emergency surgical intervention. * General condition characterised by severe limitations in physical functional capacity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications at three months postoperatively | 3 months postoperatively | Incidence of surgical and medical (including anaesthetic) complications at 3 months postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported pain | Measured at inclusion, preoperatively, 3 and 12 months postoperatively. | 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. |
| Quality of life with EQ-5D | Measured at inclusion, preoperatively, 3 and 12 months postoperatively. | 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). |
| Aesthetic outcome | Measured at clinical follow-upat 3 and 12 months postoperatively. | 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. |
| Recurrence rate | Measured at clinical follow-up at 3 and 12 months postoperatively. | Recurrence of ventral hernia. |
| Change in physical activity | meassured close to inclusion and within a few weeks preoperatively. | changes in physical activity measured with accelerometer for one week. |
| Weight | Measured at inclusion, preoperatively, 3 and 12 months postoperatively. | Weight measured i kg. |
| Complications at twelve months postoperatively | 12 months postoperatively | Incidence of surgical and medical complications at 12 months postoperatively. |
| Hba1c | at baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively. | Hba1c in bloodsamples |
| Hernia aperature width | measured peroperatively and on preoperative ct-scan preinclusion or within a few weeks after inclusion | Hernia aperature width |
| B-PETH | at baseline, perioperatively and at follow up at 3 and 12 months postoperatively. | B-PETH |
| Rutine labarotory tests | At baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively | Number of participants with abnormal routine laboratory tests results |
| Hyaluronan metabolism | Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery. | 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. |
| Collagen metabolism | Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery. | 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. |
Countries
Sweden
Contacts
Primary ContactGunnar Nordqvist, M.D.
Backup ContactViktor Holmdahl, Phd
Outcome results
None listed