NoPro - Norwegian Hernia Prophylaxis Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSykehuset Innlandet HF

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Prophylactic polypropylene onlay mesh

    Procedure/Surgery

    The 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

150 Participants
are divided into 2 treatment groups
Group A: Mesh groupExperimental treatment 1 intervention
Group B: Suture groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incisional hernia

Incisional hernia occurrence will be evaluated clinically and by CT examination after 12 months

Time frame
12 months

Secondary outcomes

1

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.

Time frame
4-6 weeks and 1 year
2

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".

Time frame
4-6 weeks and 1 year
3

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.

Time frame
4-6 weeks

Other outcomes

Sponsors and contacts

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