Abdominal Wall HerniaMeMaNCT07476560
Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment
A study testing mesh suture and planar mesh in people with Abdominal Wall Hernia and Umbilical Hernia Repair, run by Regionshospital Nordjylland at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to investigate whether mesh-suture affects wound complication rates, patient-reported quality of life, and operation time in adult patients undergoing surgery for small ventral hernias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Wall Hernia, Umbilical Hernia Repair, Epigastric Hernia Repair
- What is being tested?
- mesh suture and planar mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jan 2026to 31 Dec 2032
- 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
- Ventral hernia (maximum size 3 × 3 cm) measured with Ultrasound or CT.
- Participants must be eligible for surgical repair using either mesh-suture or planar mesh
Who cannot join
- Age < 18 years.
- Acute (emergent) operation.
- Pregnancy.
- Women with plans for future pregnancies.
- Withdrawal of informed consent during admission.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Regionshospital Nordjylland
Hjørring
Vitaly A Gameza, 045 97640520, vitgam@rn.dk
About this study
Official title: Mesh Matters: Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment - a Randomized, Blinded Multicenter Study
The goal of this clinical trial is to investigate whether mesh-suture affects wound complication rates, patient-reported quality of life, and operation time in adult patients undergoing surgery for small ventral hernias.
The main questions it aims to answer are:
Read more
Does mesh-suture reduce wound complication rates compared to planar mesh? Does mesh-suture improve patient-reported quality of life(QoL) and affect operation time compared to planar mesh?
Comparison group:
Researchers will compare standard treatment with planar mesh to the interventional treatment with mesh-suture to see whether mesh-suture leads to fewer complications, better quality of life, and shorter operation time.
Participants will:
Be randomized to receive either planar mesh or mesh-suture during hernia repair surgery.
Undergo standardized preoperative assessment, including baseline data and QoL scoring.
Attend a postoperative visit on day 7-13 for wound inspection and ultrasound. Complete QoL assessments at 90 days (telephone follow-up). Have operation time recorded and medical records reviewed for readmissions within 90 days.
- Being tested
- mesh suture, planar mesh
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesh sutureDevice
mesh suture
planar meshDevice
planar mesh
| Study group | Role | What they receive |
|---|---|---|
| mesh suture | Experimental | Not described Receives: Device: mesh suture |
| planar mesh | Active comparator | Not described Receives: Device: planar mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Occurrences (SSO) Assessed by Clinical Examination and Ultrasound
Definition: We will apply the standardized CDC (Centers for Disease Control and Prevention ) and VHWG (Ventral Hernia Working Group) definitions for SSO. Evaluation: Clinical examination. Additionally, an ultrasound examination will be performed.
Measured: 7-13 days after operation
Secondary outcomes (4)
Abdominal Hernia-Q Questionnaire
Scale description: Disease-specific patient-reported outcome measure for abdominal hernia symptoms and quality of life.
Score range: Each domain ranges from 1 to 4, where higher scores indicate better health status and fewer symptoms.
Measured: preoperative, postoperative day 10, day 90
EQ-5D-5L Index Score
Scale description: Generic health-related quality-of-life instrument assessing five dimensions of health.
Score range: The Index Score ranges from < 0 (worst health state, depending on country value set) to 1 (perfect health) and
Measured: preoperative, postoperative day 10, day 90
EQ-VAS (Visual Analogue Scale)
Patients rate their overall health on a vertical scale from 0 to 100.
Interpretation: Higher scores indicate better overall health-related quality of life.
Measured: preoperative, postoperative day 10, day 90
DURATION OF SURGERY
Operation time measured in minutes
Measured: The time interval from the first incision to the last stitch is set
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start5 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Wall HerniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nils Brandenburger, Study chair, Regionhospital Nordjylland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476560
- Sponsor's protocol ID
- VMK-id:2502170
- Other IDs
- VMK-id:2502170
- Acronym
- MeMa
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Ethics commettee requirements
Publications
Gameza V, Brandenburger N, Leutscher P, Holte K. Protocol for the mesh matters project: evaluating the efficacy of suture mesh vs. planar mesh in small ventral hernia repair - a randomized, blinded multicenter study. Hernia. 2026 Jul 31;30(1):310. doi: 10.1007/s10029-026-03815-3.
PubMed 42536214
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Matters: Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment - a Randomized, Blinded Multicenter Study
- ClinicalTrials.gov ID
- NCT07476560
- Acronym / sponsor ID
- MeMa / VMK-id:2502170
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 17 Mar 2026 (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.
The goal of this clinical trial is to investigate whether mesh-suture affects wound complication rates, patient-reported quality of life, and operation time in adult patients undergoing surgery for small ventral hernias.
The main questions it aims to answer are:
Does mesh-suture reduce wound complication rates compared to planar mesh? Does mesh-suture improve patient-reported quality of life(QoL) and affect operation time compared to planar mesh?
Comparison group:
Researchers will compare standard treatment with planar mesh to the interventional treatment with mesh-suture to see whether mesh-suture leads to fewer complications, better quality of life, and shorter operation time.
Participants will:
Be randomized to receive either planar mesh or mesh-suture during hernia repair surgery.
Undergo standardized preoperative assessment, including baseline data and QoL scoring.
Attend a postoperative visit on day 7-13 for wound inspection and ultrasound. Complete QoL assessments at 90 days (telephone follow-up). Have operation time recorded and medical records reviewed for readmissions within 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesh suture | Experimental | Device: mesh suture |
| planar mesh | Active comparator | Device: planar mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ventral hernia (maximum size 3 × 3 cm) measured with Ultrasound or CT.
- Participants must be eligible for surgical repair using either mesh-suture or planar mesh
Key exclusion criteria (5 listed)
- Age < 18 years.
- Acute (emergent) operation.
- Pregnancy.
- Women with plans for future pregnancies.
- Withdrawal of informed consent during admission.
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 suturemesh suture | Device | mesh suture |
| planar meshplanar mesh | Device | planar mesh |
Primary outcome
Surgical Site Occurrences (SSO) Assessed by Clinical Examination and Ultrasound
Time frame: 7-13 days after operation
Definition: We will apply the standardized CDC (Centers for Disease Control and Prevention ) and VHWG (Ventral Hernia Working Group) definitions for SSO. Evaluation: Clinical examination. Additionally, an ultrasound examination will be performed.
4 secondary outcomes
Abdominal Hernia-Q Questionnaire
Time frame: preoperative, postoperative day 10, day 90
EQ-5D-5L Index Score
Time frame: preoperative, postoperative day 10, day 90
EQ-VAS (Visual Analogue Scale)
Time frame: preoperative, postoperative day 10, day 90
DURATION OF SURGERY
Time frame: The time interval from the first incision to the last stitch is set
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 17 Mar 2026.
- Derived from this study: PubMed 42536214Gameza V, Brandenburger N, Leutscher P, Holte K. Protocol for the mesh matters project: evaluating the efficacy of suture mesh vs. planar mesh in small ventral hernia repair - a randomized, blinded multicenter study. Hernia. 2026 Jul 31;30(1):310. doi: 10.1007/s10029-026-03815-3.
- Individual participant dataSharing planned: No. Ethics commettee requirements
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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.
Nils Brandenburger study chair
Regionhospital Nordjylland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mesh suture and planar mesh in people with Abdominal Wall Hernia and Umbilical Hernia Repair, run by Regionshospital Nordjylland at 1 site in Denmark.
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 2 inclusion and 5 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 17 Mar 2026. 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 Denmark. 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 Vitaly A Gameza (045 97640520, vitgam@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Occurrences (SSO) Assessed by Clinical Examination and Ultrasound (time frame: 7-13 days after operation). 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 NCT07476560, which also lists 1 linked publication.
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 17 Mar 2026.