Actively Recruiting
Led by Bispebjerg Hospital · Updated on 2024-09-25
400
Participants Needed
3
Research Sites
104 weeks
Total Duration
B
Bispebjerg Hospital
Lead Sponsor
C
Copenhagen University Hospital at Herlev
Collaborating Sponsor
Researchers are studying the impact of intensive lifestyle changes before ventral hernia surgery to reduce complications, improve health, and lower costs. This trial compares a tailored prehabilitation program called STRONG with usual care for patients who have one or more risky lifestyles related to smoking, nutrition, alcohol use, or physical inactivity. The study aims to see if STRONG can cut postoperative complication rates by half within 30 days after surgery. In this randomized controlled trial, 400 patients scheduled for ventral hernia repair are assigned either to the STRONG program or to usual treatment before surgery. The STRONG program includes at least six weekly counseling sessions focused on the patient’s specific risky lifestyle factors, along with education, motivation, pharmaceutical help, and immunonutrition just before surgery. The control group receives standard preoperative advice and materials on lifestyle changes. Participants are followed at surgery or end of intervention, then at one, three, and six months after surgery. Long-term results are tracked through national registries up to two years post-surgery. Researchers measure postoperative complications within 30 days as the main outcome, along with lifestyle improvements, quality of life, costs, and complication rates up to six months. Patient expectations and reflections are also collected at baseline to help assess the program’s impact.
CONDITIONS
STRONG for Surgery & Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 6 weeks
Participants randomized to the STRONG programme receive at least six weekly counseling sessions tailored to their individual risky lifestyle factors prior to surgery. This includes education, motivational support, pharmaceutical support, and immunonutrition administered in the days before surgery.
Weekly visits for at least 6 weeks
Duration - 1 day
Participants undergo ventral hernia repair surgery following the prehabilitation or usual care period.
1 visit (in-person)
Duration - 6 months
Participants are followed up at 1 month, 3 months, and 6 months after surgery to assess postoperative outcomes, lifestyle changes, and health-related quality of life.
3 visits (in-person or remote) at 1, 3, and 6 months post surgery
Duration - 2 years
Long-term outcomes including health, complications, and costs are monitored using national registers up to two years after surgery.
No participant visits; data collected from national registers
Total: 3 locations
1
Copenhagen University Hospital at Herlev
Herlev, Denmark, 2730
Actively Recruiting
2
Holbaek Sygehus
Holbæk, Denmark, 4300
Not Yet Recruiting
3
Zealand University Hospital
Køge, Denmark, 4600
Not Yet Recruiting
H
Hanne Tønnesen, Professor MD
S
Sofie AS Jensen, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Sofie Anne-Marie Skovbo Jensen, Susanne Vahr Lauridsen, Siv Fonnes...
https://pubmed.ncbi.nlm.nih.gov/40435308