Incisional Hernia OccurencePhase 3PRIMANCT00761475
Primary Mesh Closure of Abdominal Midline Wounds
A Phase 3 study testing mesh supported closure and primary closure in people with Incisional Hernia Occurence, run by Erasmus Medical Center at 12 sites in 3 countries.
Trial summary
Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia Occurence
- What is being tested?
- mesh supported closure and primary closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Feb 2009to Apr 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Every elective midline laparotomy for patients with Abdominal Aortic Aneurysm and patients with a BMI of more than 27.
- Signed informed consent
- Aortic reconstruction for obstructive disease
- Life expectancy less than 24 months
- Pregnant women
Who cannot join
- Age < 18 years
- Emergency procedure
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Netherlands7 sites
IJsselland Ziekenhuis
Capelle aan den IJssel
Scheper Ziekenhuis
Emmen
Erasmus Medical Center
Rotterdam, South Holland, 3015 CE
Maasstad Ziekenhuis
Rotterdam
Sint Franciscus Gasthuis
Rotterdam
Maxima Medisch Centrum
Veldhoven
Isala klinieken
Zwolle
Germany4 sites
Berlin-Charite Universitatsklinikum
Berlin
Hamburg-Eppefdorf Universitatsklinikum
Hamburg
Heidelberg University Medical Center
Heidelberg
Munchen University Medical Center
München
About this study
Official title: Primary Mesh Closure of Abdominal Midline Wounds; a Prospective Randomized Multicenter Trial
Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. Major risk factors for incisional hernia after a laparotomy, like obesity, steroid use, malnutrition, smoking and connective tissue disorders, are known. Despite this knowledge, there has not yet been developed a sufficient method for prevention. One specific group of high risk patients are patients with an abdominal aortic aneurysm (AAA). The relationship between aortic aneurysm and other abdominal wall hernias, like inguinal hernias, has been reported. Retrospective and prospective studies have shown an average risk for incisional hernia after AAA repair of 31.6 %. Another high risk group is the group of obese patients. Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. Considering only 50 % of incisional hernia will be clinically evident in the first 12 months, the total incidence will be above 30%. This high risk group of patients with obesitas and aneurysmatic disease can benefit most from prevention. Some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomal surgery. However, there has not been performed an adequate randomized controlled trial to study the prevention of incisional hernias. Our hypothesis is that incisional hernia prevention with use of prosthetic mesh after laparotomy is effective in patients with aortic aneurysm and in obese patients with a BMI of more than 27.
- Conditions
- Incisional Hernia Occurence
- Being tested
- mesh supported closure, primary closure
- Keywords
- incisional hernia
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesh supported closureProcedure or surgery
onlay mesh supported closure midline laparotomy
primary closureProcedure or surgery
primary closure of the midline
mesh supported closureProcedure or surgery
sublay mesh supported closure midline laparotomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | primary closure of the midline Receives: Procedure: primary closure |
| 2 | Active comparator | onlay mesh supported closure Receives: Procedure: mesh supported closure |
| 3 | Active comparator | sublay mesh supported closure Receives: Procedure: mesh supported closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
incisional hernia occurence
Measured: 2 years
Secondary outcomes (3)
complications
Measured: 1 month
post-operative pain
Measured: 1 month
quality of life
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2012
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Incisional Hernia OccurenceStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Aesculap AG
- Responsible party
- Principal investigator, Hasan Eker, Erasmus Medical Center
- Investigators
- J.F. Lange, Professor, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761475
- Sponsor's protocol ID
- PRIMA TRIAL
- Acronym
- PRIMA
- Status last verified
- Oct 2016
- First submitted
- 26 Sep 2008
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Van den Dop LM, Sneiders D, Yurtkap Y, Werba A, van Klaveren D, Pierik REGJM, Reim D, Timmermans L, Fortelny RH, Mihaljevic AL, Kleinrensink GJ, Tanis PJ, Lange JF, Jeekel J; PRIMA Trialist Group. Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA): long-term outcomes of a multicentre, double-blind, randomised controlled trial. Lancet Reg Health Eur. 2023 Nov 22;36:100787. doi: 10.1016/j.lanepe.2023.100787. eCollection 2024 Jan.
PubMed 38188275Jairam AP, Timmermans L, Eker HH, Pierik REGJM, van Klaveren D, Steyerberg EW, Timman R, van der Ham AC, Dawson I, Charbon JA, Schuhmacher C, Mihaljevic A, Izbicki JR, Fikatas P, Knebel P, Fortelny RH, Kleinrensink GJ, Lange JF, Jeekel HJ; PRIMA Trialist Group. Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial. Lancet. 2017 Aug 5;390(10094):567-576. doi: 10.1016/S0140-6736(17)31332-6. Epub 2017 Jun 20.
PubMed 28641875Timmermans L, Eker HH, Steyerberg EW, Jairam A, de Jong D, Pierik EG, Lases SS, van der Ham AC, Dawson I, Charbon J, Schuhmacher C, Izbicki JR, Neuhaus P, Knebel P, Fortelny R, Kleinrensink GJ, Jeekel J, Lange JF. Short-term results of a randomized controlled trial comparing primary suture with primary glued mesh augmentation to prevent incisional hernia. Ann Surg. 2015 Feb;261(2):276-81. doi: 10.1097/SLA.0000000000000798.
PubMed 24983993Nieuwenhuizen J, Eker HH, Timmermans L, Hop WC, Kleinrensink GJ, Jeekel J, Lange JF; PRIMA Trialist Group. A double blind randomized controlled trial comparing primary suture closure with mesh augmented closure to reduce incisional hernia incidence. BMC Surg. 2013 Oct 28;13:48. doi: 10.1186/1471-2482-13-48.
PubMed 24499111
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Mesh Closure of Abdominal Midline Wounds; a Prospective Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT00761475
- Acronym / sponsor ID
- PRIMA / PRIMA TRIAL
- Conditions
- Incisional Hernia Occurence
- Keywords
- incisional hernia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Aesculap AG
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Sep 2008 (estimated)
- 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.
Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. Major risk factors for incisional hernia after a laparotomy, like obesity, steroid use, malnutrition, smoking and connective tissue disorders, are known. Despite this knowledge, there has not yet been developed a sufficient method for prevention. One specific group of high risk patients are patients with an abdominal aortic aneurysm (AAA). The relationship between aortic aneurysm and other abdominal wall hernias, like inguinal hernias, has been reported. Retrospective and prospective studies have shown an average risk for incisional hernia after AAA repair of 31.6 %. Another high risk group is the group of obese patients. Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. Considering only 50 % of incisional hernia will be clinically evident in the first 12 months, the total incidence will be above 30%. This high risk group of patients with obesitas and aneurysmatic disease can benefit most from prevention. Some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomal surgery. However, there has not been performed an adequate randomized controlled trial to study the prevention of incisional hernias. Our hypothesis is that incisional hernia prevention with use of prosthetic mesh after laparotomy is effective in patients with aortic aneurysm and in obese patients with a BMI of more than 27.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: primary closureprimary closure of the midline |
| 2 | Active comparator | Procedure: mesh supported closureonlay mesh supported closure |
| 3 | Active comparator | Procedure: mesh supported closuresublay mesh supported closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Every elective midline laparotomy for patients with Abdominal Aortic Aneurysm and patients with a BMI of more than 27.
- Signed informed consent
- Aortic reconstruction for obstructive disease
- Life expectancy less than 24 months
- Pregnant women
Key exclusion criteria (2 listed)
- Age < 18 years
- Emergency procedure
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 |
|---|---|---|
| mesh supported closureonlay mesh supported closure midline laparotomy | Procedure or surgery | 2 |
| primary closureprimary closure of the midline | Procedure or surgery | 1 |
| mesh supported closuresublay mesh supported closure midline laparotomy | Procedure or surgery | 3 |
Primary outcome
incisional hernia occurence
Time frame: 2 years
3 secondary outcomes
complications
Time frame: 1 month
post-operative pain
Time frame: 1 month
quality of life
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Derived from this study: PubMed 38188275Van den Dop LM, Sneiders D, Yurtkap Y, Werba A, van Klaveren D, Pierik REGJM, Reim D, Timmermans L, Fortelny RH, Mihaljevic AL, Kleinrensink GJ, Tanis PJ, Lange JF, Jeekel J; PRIMA Trialist Group. Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA): long-term outcomes of a multicentre, double-blind, randomised controlled trial. Lancet Reg Health Eur. 2023 Nov 22;36:100787. doi: 10.1016/j.lanepe.2023.100787. eCollection 2024 Jan.
- Derived from this study: PubMed 28641875Jairam AP, Timmermans L, Eker HH, Pierik REGJM, van Klaveren D, Steyerberg EW, Timman R, van der Ham AC, Dawson I, Charbon JA, Schuhmacher C, Mihaljevic A, Izbicki JR, Fikatas P, Knebel P, Fortelny RH, Kleinrensink GJ, Lange JF, Jeekel HJ; PRIMA Trialist Group. Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial. Lancet. 2017 Aug 5;390(10094):567-576. doi: 10.1016/S0140-6736(17)31332-6. Epub 2017 Jun 20.
- Derived from this study: PubMed 24983993Timmermans L, Eker HH, Steyerberg EW, Jairam A, de Jong D, Pierik EG, Lases SS, van der Ham AC, Dawson I, Charbon J, Schuhmacher C, Izbicki JR, Neuhaus P, Knebel P, Fortelny R, Kleinrensink GJ, Jeekel J, Lange JF. Short-term results of a randomized controlled trial comparing primary suture with primary glued mesh augmentation to prevent incisional hernia. Ann Surg. 2015 Feb;261(2):276-81. doi: 10.1097/SLA.0000000000000798.
- Derived from this study: PubMed 24499111Nieuwenhuizen J, Eker HH, Timmermans L, Hop WC, Kleinrensink GJ, Jeekel J, Lange JF; PRIMA Trialist Group. A double blind randomized controlled trial comparing primary suture closure with mesh augmented closure to reduce incisional hernia incidence. BMC Surg. 2013 Oct 28;13:48. doi: 10.1186/1471-2482-13-48.
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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. This study is not recruiting at the moment.
J.F. Lange, Professor principal investigator
Erasmus Medical Center
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mesh supported closure and primary closure in people with Incisional Hernia Occurence, run by Erasmus Medical Center at 12 sites in 3 countries.
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 2 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: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands, Germany, Austria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incisional hernia occurence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00761475, which also lists 4 linked publications.
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 28 Oct 2016.