Ventral HerniaNCT03938688
Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation
A study testing Mesh placement with Transfascial Sutures in people with Ventral Hernia and Incisional Hernia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This will be a single blinded, registry based, non-inferiority, randomized control trial comparing transfacial sutures for mesh fixation to no mesh fixation in open retromuscular repairs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia, Incisional Hernia
- What is being tested?
- Mesh placement with Transfascial Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2019to 18 Dec 2022
- Phase
- Interventional
- 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
- Undergoing elective open ventral hernia repair, where the midline fascia can be approximated and mesh will be placed in the retromuscular position
- A midline approach to hernia repair
- Hernia widths equal to or less than 20cm measured intraoperatively
Who cannot join
- Patients unable to give consent and vulnerable populations.
- Parastomal hernias
- Hernia width measuring more than 20cm intraoperatively
- Patients planned for minimally invasive approaches or open repairs with mesh placed in a position other than retromuscular, or those who were not able to undergo successful retromuscular mesh placement.
- Open repairs performed through a different incision than the standard midline approach
- Inability to close the midline fascia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, 44195
About this study
Official title: Two-armed Single Blinded Non-inferiority Registry Based Randomized Control Trial Comparing Transfascial Sutures for Mesh Fixation to No Mesh Fixation for Open Retromuscular Repairs
This will be a single blinded, registry based, non-inferiority, randomized control trial comparing transfacial sutures for mesh fixation to no mesh fixation in open retromuscular repairs. The primary outcome of interest is recurrence measured one year postoperatively as per standard of care at Cleveland Clinic Center for Abdominal Core Health. Hence, recurrence will be measured using either physical examination, CT scan, or the Ventral Hernia Recurrence Inventory (VHRI). Study population will include all adult patients (18 years or older) undergoing elective open ventral hernia repair of a clean (Wound class I) defect, where the midline fascia can be approximated and mesh will be placed in the retromuscular position. Only a midline approach to hernia repair and hernia widths equal to or less than 20cm measured intraoperatively will be included
Read the detailed description
The techniques of mesh fixation in open incisional hernia repair is an active area of discussion and debate. When first described, the posterior component separation with the transversus abdominis muscle release involved placing the mesh in the retromuscular space, and fixating it circumferentially with transfascial sutures. These sutures penetrate the entire length of the abdominal wall and can be a significant source of pain. This study aims to evaluate the effect of using no fixation on recurrence rates, compared to the standard of care of using transfacial sutures. The investigators hypothesize that recurrences rates for patients who receive no fixation will be non-inferior to those receiving transfascial sutures.
This will be a single blinded, registry based, non-inferiority, randomized control trial comparing transfacial sutures for mesh fixation to no mesh fixation in open retromuscular repairs. This will be a two-arm trial with intervention 1: intervention 2 and control allocation ratio of 1:1. The Americas Hernia Society Quality Collaborative (AHSQC) will serve as the platform for data collection. The AHSQC is a multicenter, nationwide quality improvement effort with the mission of improving the quality of hernia care. Data points not recorded in the AHSQC will be collected by a trained research coordination or research fellow and uploaded into a Research Electronic Data Capture (RedCAP®) database hosted at the Cleveland Clinic
Study population will include all adult patients (≥ 18 years) undergoing elective open ventral hernia repair, where the midline fascia can be approximated and mesh will be placed in the retromuscular position. Only a midline approach to hernia repair and hernia widths equal to or less than 20cm measured intraoperatively will be included. Exclusion criteria include patients unable to give consent, vulnerable populations, parastomal hernias, hernia width measuring more than 20cm intraoperatively, patients planned for minimally invasive approaches or open repairs with mesh placed in a position other than retromuscular, or those who were not able to undergo successful retromuscular mesh placement. Finally, open repairs performed through a different incision than the standard midline approach will also be considered exclusion criteria, as well as the inability to close the midline fascia.
Study Interventions:
- Intervention 1 (Control): Mesh will be placed in the retromuscular space, with wide overlap on all sides. Full thickness transfascial sutures will be placed circumferentially to secure the mesh using slowly absorbable no. 1 sutures. A total of six transfascial sutures will be placed universally for all patients with additional sutures allowed according to each surgeon's discretion. Additional bone or ligament sutures for mesh fixation will be allowed according to each surgeon's discretion.
- Intervention 2: Mesh will be placed in the retromuscular space, with wide overlap on all sides. No fixation method will be used. Bone or ligament sutures for mesh fixation will not be allowed.
Specific Aims:
- Aim 1: To investigate the non-inferiority of recurrence rates in patients receiving no fixation for a mesh placed in retromuscular position compared to those receiving circumferential transfascial suture fixation. Either physical examination, CT scan, or the Ventral Hernia Recurrence Inventory (VHRI) will be used to measure recurrence at one-year follow up.
- Aim 2: To determine if no mesh fixation results in less pain in the immediate postoperative period, measured by the Numeric Pain Rating Scale (NRS-11).
- Aim 3: To determine if no mesh fixation results in less pain on 30 day follow up, measured by using the Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey
- Aim 4: To determine if in-hospital intravenous and oral opioid consumption will differ between those who received transfascial sutures and those who did not receive any fixation.
- Aim 5: To determine if length of stay will differ between those who received transfascial sutures and those who did not receive any fixation.
- Conditions
- Ventral Hernia, Incisional Hernia
- Being tested
- Mesh placement with Transfascial Sutures
- Keywords
- ventral hernia repair, mesh, pain, incisional hernia
- Medical subject headings
- Hernia, Ventral, Incisional Hernia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh placement with Transfascial SuturesProcedure or surgery
Sutures that pass through the full thickness of the abdominal wall, which are used routinely for mesh fixation
| Study group | Role | What they receive |
|---|---|---|
| Transfascial sutures for mesh fixation | Other | Mesh will be placed in the retromuscular space, with wide overlap on all sides. Full thickness transfascial sutures will be placed circumferentially to secure the mesh using slowly absorbable no. 1 sutures. A total of at least six transfascial sutures will be placed universally for all patients with additional sutures allowed according to each surgeon's discretion. Additional bone or ligament sutures for mesh fixation will be allowed according to each surgeon's discretion. Receives: Procedure: Mesh placement with Transfascial Sutures |
| No mesh fixation | No intervention | Mesh will be placed in the retromuscular space, with wide overlap on all sides. No fixation method will be used. Bone or ligament sutures for mesh fixation will not be allowed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
primary outcome of interest is recurrence measured one year postoperatively as per standard of care at the Cleveland Clinic Center for Abdominal Core Health. Hence, recurrence will be measured using either physical examination, CT scan, or the Ventral Hernia Recurrence Inventory (VHRI), either during a physical or a virtual clinic visit and/or using the telephone. The VHRI is a validated patient reported outcomes tool, a three-question survey that can be administered directly to patients without clinical interaction.
Measured: One year
Secondary outcomes (4)
Post-operative pain
Pain scores will be measured by Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey. The PROMIS pain intensity 3a survery is a National Institute of Health-developed validated tool, which focuses on PROs of pain characteristics.
Measured: Baseline and 30 day follow up. The 30-day follow up period will extend from 15 - 45 days postoperatively.
Post-operative pain
Pain scores will be measured using the Numeric Pain Rating Scale (NRS-11). The NRS-11 is Likert scale where the patient mark their current pain on scale from 1 to 10.
Measured: Baseline, first 7 days post-operatively, and 30 day follow up. The 30-day follow up period will extend from 15 - 45 days postoperatively.
Daily opioid requirements
Opioid requirements will be assessed by measuring the cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations. The total dose of opioid consumption will be converted to morphine equivalence.
Measured: first 7 days of the post-operative period
Length of stay
Length of in-hospital stay will be measured
Measured: From date of admission to hospital until the date of discharge from hospital, assessed up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start21 Oct 2019
- Primary completion18 Dec 2022
- Study completion18 Dec 2022
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 Ventral HerniaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajita Prabhu, MD, The Cleveland Clinic
- Investigators
- Ajita S Prabhu, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938688
- Sponsor's protocol ID
- 19-333
- Status last verified
- Jun 2023
- First submitted
- 1 May 2019
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, rather the results of the aggregate groups of patients will be shared
Publications
Ellis RC, Petro CC, Krpata DM, Beffa LRA, Miller BT, Montelione KC, Maskal SM, Tu C, Huang LC, Lau B, Fafaj A, Rosenblatt S, Rosen MJ, Prabhu AS. Transfascial Fixation vs No Fixation for Open Retromuscular Ventral Hernia Repairs: A Randomized Clinical Trial. JAMA Surg. 2023 Aug 1;158(8):789-795. doi: 10.1001/jamasurg.2023.1786.
PubMed 37342018
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-armed Single Blinded Non-inferiority Registry Based Randomized Control Trial Comparing Transfascial Sutures for Mesh Fixation to No Mesh Fixation for Open Retromuscular Repairs
- ClinicalTrials.gov ID
- NCT03938688
- Acronym / sponsor ID
- 19-333
- Conditions
- Ventral Hernia, Incisional Hernia
- Keywords
- ventral hernia repair, mesh, pain, incisional hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 18 Dec 2022 (actual)
- First posted
- 6 May 2019 (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.
This will be a single blinded, registry based, non-inferiority, randomized control trial comparing transfacial sutures for mesh fixation to no mesh fixation in open retromuscular repairs. The primary outcome of interest is recurrence measured one year postoperatively as per standard of care at Cleveland Clinic Center for Abdominal Core Health. Hence, recurrence will be measured using either physical examination, CT scan, or the Ventral Hernia Recurrence Inventory (VHRI). Study population will include all adult patients (18 years or older) undergoing elective open ventral hernia repair of a clean (Wound class I) defect, where the midline fascia can be approximated and mesh will be placed in the retromuscular position. Only a midline approach to hernia repair and hernia widths equal to or less than 20cm measured intraoperatively will be included
Detailed description
The techniques of mesh fixation in open incisional hernia repair is an active area of discussion and debate. When first described, the posterior component separation with the transversus abdominis muscle release involved placing the mesh in the retromuscular space, and fixating it circumferentially with transfascial sutures. These sutures penetrate the entire length of the abdominal wall and can be a significant source of pain. This study aims to evaluate the effect of using no fixation on recurrence rates, compared to the standard of care of using transfacial sutures. The investigators hypothesize that recurrences rates for patients who receive no fixation will be non-inferior to those receiving transfascial sutures.
This will be a single blinded, registry based, non-inferiority, randomized control trial comparing transfacial sutures for mesh fixation to no mesh fixation in open retromuscular repairs. This will be a two-arm trial with intervention 1: intervention 2 and control allocation ratio of 1:1. The Americas Hernia Society Quality Collaborative (AHSQC) will serve as the platform for data collection. The AHSQC is a multicenter, nationwide quality improvement effort with the mission of improving the quality of hernia care. Data points not recorded in the AHSQC will be collected by a trained research coordination or research fellow and uploaded into a Research Electronic Data Capture (RedCAP®) database hosted at the Cleveland Clinic
Study population will include all adult patients (≥ 18 years) undergoing elective open ventral hernia repair, where the midline fascia can be approximated and mesh will be placed in the retromuscular position. Only a midline approach to hernia repair and hernia widths equal to or less than 20cm measured intraoperatively will be included. Exclusion criteria include patients unable to give consent, vulnerable populations, parastomal hernias, hernia width measuring more than 20cm intraoperatively, patients planned for minimally invasive approaches or open repairs with mesh placed in a position other than retromuscular, or those who were not able to undergo successful retromuscular mesh placement. Finally, open repairs performed through a different incision than the standard midline approach will also be considered exclusion criteria, as well as the inability to close the midline fascia.
Study Interventions:
- Intervention 1 (Control): Mesh will be placed in the retromuscular space, with wide overlap on all sides. Full thickness transfascial sutures will be placed circumferentially to secure the mesh using slowly absorbable no. 1 sutures. A total of six transfascial sutures will be placed universally for all patients with additional sutures allowed according to each surgeon's discretion. Additional bone or ligament sutures for mesh fixation will be allowed according to each surgeon's discretion.
- Intervention 2: Mesh will be placed in the retromuscular space, with wide overlap on all sides. No fixation method will be used. Bone or ligament sutures for mesh fixation will not be allowed.
Specific Aims:
- Aim 1: To investigate the non-inferiority of recurrence rates in patients receiving no fixation for a mesh placed in retromuscular position compared to those receiving circumferential transfascial suture fixation. Either physical examination, CT scan, or the Ventral Hernia Recurrence Inventory (VHRI) will be used to measure recurrence at one-year follow up.
- Aim 2: To determine if no mesh fixation results in less pain in the immediate postoperative period, measured by the Numeric Pain Rating Scale (NRS-11).
- Aim 3: To determine if no mesh fixation results in less pain on 30 day follow up, measured by using the Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey
- Aim 4: To determine if in-hospital intravenous and oral opioid consumption will differ between those who received transfascial sutures and those who did not receive any fixation.
- Aim 5: To determine if length of stay will differ between those who received transfascial sutures and those who did not receive any fixation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfascial sutures for mesh fixation | Other | Procedure: Mesh placement with Transfascial SuturesMesh will be placed in the retromuscular space, with wide overlap on all sides. Full thickness transfascial sutures will be placed circumferentially to secure the mesh using slowly absorbable no. 1 sutures. A total of at least six transfascial sutures will be placed universally for all patients with additional sutures allowed according to each surgeon's discretion. Additional bone or ligament sutures for mesh fixation will be allowed according to each surgeon's discretion. |
| No mesh fixation | No intervention | –Mesh will be placed in the retromuscular space, with wide overlap on all sides. No fixation method will be used. Bone or ligament sutures for mesh fixation will not be allowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing elective open ventral hernia repair, where the midline fascia can be approximated and mesh will be placed in the retromuscular position
- A midline approach to hernia repair
- Hernia widths equal to or less than 20cm measured intraoperatively
Key exclusion criteria (6 listed)
- Patients unable to give consent and vulnerable populations.
- Parastomal hernias
- Hernia width measuring more than 20cm intraoperatively
- Patients planned for minimally invasive approaches or open repairs with mesh placed in a position other than retromuscular, or those who were not able to undergo successful retromuscular mesh placement.
- Open repairs performed through a different incision than the standard midline approach
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 placement with Transfascial SuturesSutures that pass through the full thickness of the abdominal wall, which are used routinely for mesh fixation | Procedure or surgery | Transfascial sutures for mesh fixation |
Primary outcome
Recurrence
Time frame: One year
primary outcome of interest is recurrence measured one year postoperatively as per standard of care at the Cleveland Clinic Center for Abdominal Core Health. Hence, recurrence will be measured using either physical examination, CT scan, or the Ventral Hernia Recurrence Inventory (VHRI), either during a physical or a virtual clinic visit and/or using the telephone. The VHRI is a validated patient reported outcomes tool, a three-question survey that can be administered directly to patients without clinical interaction.
4 secondary outcomes
Post-operative pain
Time frame: Baseline and 30 day follow up. The 30-day follow up period will extend from 15 - 45 days postoperatively.
Post-operative pain
Time frame: Baseline, first 7 days post-operatively, and 30 day follow up. The 30-day follow up period will extend from 15 - 45 days postoperatively.
Daily opioid requirements
Time frame: first 7 days of the post-operative period
Length of stay
Time frame: From date of admission to hospital until the date of discharge from hospital, assessed up to 60 weeks
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 22 Jun 2023.
- Derived from this study: PubMed 37342018Ellis RC, Petro CC, Krpata DM, Beffa LRA, Miller BT, Montelione KC, Maskal SM, Tu C, Huang LC, Lau B, Fafaj A, Rosenblatt S, Rosen MJ, Prabhu AS. Transfascial Fixation vs No Fixation for Open Retromuscular Ventral Hernia Repairs: A Randomized Clinical Trial. JAMA Surg. 2023 Aug 1;158(8):789-795. doi: 10.1001/jamasurg.2023.1786.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, rather the results of the aggregate groups of patients will be shared
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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.
Ajita S Prabhu principal investigator
The Cleveland Clinic
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 placement with Transfascial Sutures in people with Ventral Hernia and Incisional Hernia, run by The Cleveland Clinic at 1 site in United States.
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 3 inclusion and 6 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 22 Jun 2023. 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 United States. 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?
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?
Recurrence (time frame: One year). 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 NCT03938688, 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 22 Jun 2023.