Incisional Hernia After Midline LaparotomyNoProNCT06858020
NoPro - Norwegian Hernia Prophylaxis Study
A study testing Prophylactic polypropylene onlay mesh in people with Incisional Hernia After Midline Laparotomy and Quality of Life (QOL), run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia After Midline Laparotomy, Quality of Life (QOL), Burst Abdomen
- What is being tested?
- Prophylactic polypropylene onlay mesh
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 17 Feb 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery predominantly done my midline laparotomy
- Age 18 years old or older
- Written consent by patient/family
- Midline laparotomy with delayed closure
- No exclusion criteria
Who cannot join
- Age under 18 years
- Pregnancy
- Previous abdominal midline hernia mesh repair
- Abdominal compartment syndrome
- Linea alba closure not possible
- Life expectancy under six months
- Hernia in the midline with transverse diameter lager than 2 cm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Innlandet Hospital Trust
Hamar
Lars Martin Rekkedal, MD BBA, 0047 90041959, lars.martin.rekkedal@sykehuset-innlandet.no
About this study
Official title: NoPro - Norwegian Hernia Prophylaxis Study: Onlay Mesh Versus Small Bite Suture Technique Closure of Midline Laparotomies
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.
Read the detailed description
An incisional hernia (IH) is a defect in the abdominal wall at the site of a surgical scar, leading to the protrusion of abdominal contents through the defect. It is a common complication following midline laparotomy, with incidence rates ranging from 9% to 40% in the general population, and up to 69% in high-risk patients. Several studies have been conducted on the prevention of IH, and one established intervention is the use of a synthetic mesh to reinforce the suture closure of the abdomen after midline laparotomy. However, the use of mesh in this context is not widespread in Norway, and there are no Norwegian studies on IH prevention following midline laparotomy. This study aims to contribute to the broader knowledge base and encourage Norwegian surgeons to consider using prophylactic meshes.
The study will involve three Norwegian hospitals: Hamar Hospital, Gjøvik Hospital, and Lillehammer Hospital. Participants will be patients scheduled for midline laparotomy at these hospitals who consent to participate, meet the inclusion criteria, and do not meet any exclusion criteria. Participants will be randomly assigned to two groups, each receiving a different variation of fascia closure during laparotomy. One group will undergo closure using the standard small-bites technique only, while the other group will undergo closure with the small-bites technique in addition to an onlay polypropylene mesh.
The primary outcome is the occurrence of incisional hernia one year after surgery, identified through clinical examination and CT scan. Additionally, surgical site occurrences (e.g., hematoma, infection, seroma, wound dehiscence) will be recorded four to six weeks post-surgery. Quality of life and pain levels will also be assessed at both four to six weeks and one year after surgery.
- Conditions
- Incisional Hernia After Midline Laparotomy, Quality of Life (QOL), Burst Abdomen, Surgical Site Infections
- Being tested
- Prophylactic polypropylene onlay mesh
- Keywords
- prophylactic mesh, onlay, incisional hernia, midline laparotomy
- Medical subject headings
- Surgical Wound Infection, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic polypropylene onlay meshProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Mesh group | Experimental | 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. These patients receive a subcutaneous drain to prevent seroma. Receives: Procedure: Prophylactic polypropylene onlay mesh |
| Suture group | No intervention | The patients in the suture group are closed with small bites technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia
Incisional hernia occurrence will be evaluated clinically and by CT examination after 12 months
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 4-6 weeks and 1 year
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".
Measured: 4-6 weeks and 1 year
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.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start17 Feb 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia After Midline LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Martin Rekkedal, MD BBA, Study chair, Chief of surgery Hamar Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858020
- Sponsor's protocol ID
- 761933
- Acronym
- NoPro
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NoPro - Norwegian Hernia Prophylaxis Study: Onlay Mesh Versus Small Bite Suture Technique Closure of Midline Laparotomies
- ClinicalTrials.gov ID
- NCT06858020
- Acronym / sponsor ID
- NoPro / 761933
- Conditions
- Incisional Hernia After Midline Laparotomy, Quality of Life (QOL), Burst Abdomen, Surgical Site Infections
- Keywords
- prophylactic mesh, onlay, incisional hernia, midline laparotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An incisional hernia (IH) is a defect in the abdominal wall at the site of a surgical scar, leading to the protrusion of abdominal contents through the defect. It is a common complication following midline laparotomy, with incidence rates ranging from 9% to 40% in the general population, and up to 69% in high-risk patients. Several studies have been conducted on the prevention of IH, and one established intervention is the use of a synthetic mesh to reinforce the suture closure of the abdomen after midline laparotomy. However, the use of mesh in this context is not widespread in Norway, and there are no Norwegian studies on IH prevention following midline laparotomy. This study aims to contribute to the broader knowledge base and encourage Norwegian surgeons to consider using prophylactic meshes.
The study will involve three Norwegian hospitals: Hamar Hospital, Gjøvik Hospital, and Lillehammer Hospital. Participants will be patients scheduled for midline laparotomy at these hospitals who consent to participate, meet the inclusion criteria, and do not meet any exclusion criteria. Participants will be randomly assigned to two groups, each receiving a different variation of fascia closure during laparotomy. One group will undergo closure using the standard small-bites technique only, while the other group will undergo closure with the small-bites technique in addition to an onlay polypropylene mesh.
The primary outcome is the occurrence of incisional hernia one year after surgery, identified through clinical examination and CT scan. Additionally, surgical site occurrences (e.g., hematoma, infection, seroma, wound dehiscence) will be recorded four to six weeks post-surgery. Quality of life and pain levels will also be assessed at both four to six weeks and one year after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh group | Experimental | Procedure: Prophylactic polypropylene onlay meshThe 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. These patients receive a subcutaneous drain to prevent seroma. |
| Suture group | No intervention | –The patients in the suture group are closed with small bites technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Surgery predominantly done my midline laparotomy
- Age 18 years old or older
- Written consent by patient/family
- Midline laparotomy with delayed closure
- No exclusion criteria
Key exclusion criteria (7 listed)
- Age under 18 years
- Pregnancy
- Previous abdominal midline hernia mesh repair
- Abdominal compartment syndrome
- Linea alba closure not possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic polypropylene onlay meshThe 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. | Procedure or surgery | Mesh group |
Primary outcome
Incisional hernia
Time frame: 12 months
Incisional hernia occurrence will be evaluated clinically and by CT examination after 12 months
3 secondary outcomes
Quality of Life
Time frame: 4-6 weeks and 1 year
Level of pain
Time frame: 4-6 weeks and 1 year
Symptomatic surgical site occurrence (SSO)
Time frame: 4-6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No
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Incisional Hernia After Midline Laparotomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars Martin Rekkedal, MD BBA study chair
Chief of surgery Hamar Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic polypropylene onlay mesh in people with Incisional Hernia After Midline Laparotomy and Quality of Life (QOL), run by Sykehuset Innlandet HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gjertrud H Kjostolfsen, MD (0047 90236405, gjertrud.hole.kjostolfsen@sykehuset-innlandet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional hernia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.