Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Region Norrbotten | OTHER |
| Region Västerbotten | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention group participates in a home-based, multimodal prehabilitation programme addressing physical inactivity, obesity, inadequate management of comorbidities, smoking, and alcohol consumption. |
|
| control | No Intervention | The control group will receive basic guidance on physical activity and weight management during the preoperative consultation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preoptimisation programme | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications at three months postoperatively | Incidence of surgical and medical (including anaesthetic) complications at 3 months postoperatively. | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Complications at twelve months postoperatively | Incidence of surgical and medical complications at 12 months postoperatively. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gunnar Nordqvist, M.D. | Contact | +46768227094 | gunnar.nordqvist@umu.se | |
| Viktor Holmdahl, Phd | Contact | viktor.holmdahl@umu.se |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gällivare hospital | Recruiting | Gällivare | Norrbotten County | 98238 | Sweden |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006547 | Hernia |
| D006555 | Hernia, Ventral |
| D000069290 | Incisional Hernia |
| D006554 | Hernia, Umbilical |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046449 | Hernia, Abdominal |
| D011183 | Postoperative Complications |
Not provided
Not provided
This study is a prospective, single-blinded, multicentre, randomised, controlled superiority trial employing a parallel-group design with an allocation ratio of 1:1.
Not provided
Not provided
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.
|
| 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). | 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. | Measured at clinical follow-upat 3 and 12 months postoperatively. |
| Recurrence rate | Recurrence of ventral hernia. | 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. | meassured close to inclusion and within a few weeks preoperatively. |
| Weight | Weight measured i kg. | 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. | Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery. |
| Hba1c | Hba1c in bloodsamples | at baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively. |
| Hernia aperature width | Hernia aperature width | measured peroperatively and on preoperative ct-scan preinclusion or within a few weeks after inclusion |
| B-PETH | B-PETH | 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 | 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. | Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery. |
| Sunderby Hospital | Recruiting | Luleå | Norrbotten County | 94542 | Sweden |
|
| Lycksele Hospital | Not yet recruiting | Lycksele | Västerbotten County | 92137 | Sweden |
|
| Skellefteå Hospital | Not yet recruiting | Skellefteå | Västerbotten County | 93141 | Sweden |
|
| Umeå University Hospital | Recruiting | Umeå | Västerbotten County | Sweden |
|
| D010335 | Pathologic Processes |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |