About this trial
A multicenter randomized controlled trial comparing midline laparotomy closures using the small-bite suture technique alone to those using the small-bite suture technique with an additional onlay prophylactic polypropylene mesh. The primary endpoint is the incidence of incisional hernias in both groups after one year.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Surgery predominantly done my midline laparotomy
Age 18 years old or older
Written consent by patient/family
Midline laparotomy with delayed closure
Disqualifiers
Age under 18 years
Pregnancy
Previous abdominal midline hernia mesh repair
Abdominal compartment syndrome
Trial design
Parallel
Treatments tested in this trial
Prophylactic polypropylene onlay mesh
Procedure/SurgeryThe patients in the mesh group are closed with small bites technique and in addition receiving an onlay polypropylene mesh when closing the fascia in midline laparotomies.
Treatment groups
Trial outcomes
Primary outcomes
Incisional hernia
Incisional hernia occurrence will be evaluated clinically and by CT examination after 12 months
Secondary outcomes
Quality of Life
Quality of life will be measured preoperatively for elective patients and after 4-6 weeks and after 1 year for all patients. Quality of life will be measured using 5-level EQ-5D version (EQ-5D-5L) provided by the EuroQol group. The system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Level of pain
Pain level will be measured preoperatively for elective patients and after 4-6 weeks and after 1 year for all patients. The level will be measured using VAS-scale from 0 to 10 where 0 is explained as "no pain" and 10 is explained as "the worst pain you can possibly imagine".
Symptomatic surgical site occurrence (SSO)
Symptomatic surgical site occurrence (SSO)when the patient it discharged and after 4-6 weeks. Surgical site occurence including seroma, hematoma, wound dehiscence and infection.
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