Actively Recruiting
Preoptimisation in Ventral Hernia Surgery: A Randomised Trial Evaluating a Multimodal Prehabilitation Programme
Led by Umeå University · Updated on 2026-01-05
130
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
R
Region Norrbotten
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a multimodal preoptimisation programme for patients with ventral hernia defects between four and eight centimeters wide. This randomized controlled trial compares this prehabilitation approach to surgery without structured preoptimisation, aiming to reduce complications three months after surgery. The study also explores molecular changes related to collagen metabolism by collecting tissue biopsies and blood samples around the time of surgery. Participants in the intervention group follow a home-based prehabilitation programme lasting at least three months before surgery. This programme targets physical inactivity, obesity, comorbidities, smoking, and alcohol use, and is designed for both rural and urban populations. The control group receives basic advice on physical activity and weight management during their preoperative consultation. During the study, researchers collect biopsies of skin, muscle, and fascia during surgery and take blood samples before and after surgery to analyze molecular effects. Participants will be monitored for complications up to three months postoperatively, with additional assessments at twelve months including pain, quality of life, aesthetic outcomes, hernia recurrence, physical activity, weight, and various laboratory tests. The total participation time covers preoperative optimization and follow-up visits extending up to one year after surgery.
CONDITIONS
Brief Title
Preoptimisation in Ventral Hernia Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older.
You will not qualify if you...
- Expected survival of less than three years.
- Inability to understand oral and written information or to provide informed consent.
- Acute hernia complications requiring emergency surgery.
- Severe limitations in physical functional capacity affecting general condition.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Minimum of 3 months
Participants in the intervention group follow a home-based, multimodal prehabilitation programme targeting physical inactivity, obesity, comorbidities, smoking, and alcohol use for a minimum of three months before surgery. Participants in the control group receive basic guidance on physical activity and weight management during the preoperative consultation.
1 baseline visit and 1 preoperative visit
Duration - Up to discharge after surgery
Participants undergo ventral hernia surgery followed by immediate post-operative care including biopsies and laboratory tests taken perioperatively and on postoperative day 1.
1 surgical visit and 1 postoperative visit
Duration - 12 months postoperatively
Participants are followed up at 3 and 12 months postoperatively to assess complications, patient-reported outcomes, quality of life, aesthetic outcomes, recurrence rates, and perform laboratory assessments.
Approximately 2 clinical follow-up visits
Trial Site Locations
Total: 5 locations
1
Gällivare hospital
Gällivare, Norrbotten County, Sweden, 98238
Actively Recruiting
2
Sunderby Hospital
Luleå, Norrbotten County, Sweden, 94542
Actively Recruiting
3
Lycksele Hospital
Lycksele, Västerbotten County, Sweden, 92137
Not Yet Recruiting
4
Skellefteå Hospital
Skellefteå, Västerbotten County, Sweden, 93141
Not Yet Recruiting
5
Umeå University Hospital
Umeå, Västerbotten County, Sweden
Actively Recruiting
Research Team
G
Gunnar Nordqvist, M.D.
V
Viktor Holmdahl, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here