Ventral HerniaNCT03082391
Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair
A study testing Heavy weight Mesh and Medium weight Mesh in people with Ventral Hernia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if mesh weight has an impact on postoperative pain, ventral hernia recurrence, incidence of deep wound infection, and overall quality of life following ventral hernia repair with mesh. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Heavy weight Mesh and Medium weight Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2017to 28 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Will undergo a single-stage, open, retromuscular ventral hernia repair
- CDC Wound Class 1
- Able to achieve midline fascial closure
- Hernia defect width less than or equal to 20 centimeters (measured intraoperatively)
- Able to tolerate general anesthesia
- Able to give informed consent
Who cannot join
- Patients who are less than 18 years of age
- Patients who undergo emergent ventral hernia repair
- Patients who undergo laparoscopic or robotic ventral hernia repair
- Patients with CDC Wound Class 2, 3, or 4
- Patients who are unable to undergo successful retromuscular mesh placement or who cannot achieve midline fascial closure
- Patients who undergo staged repair of their ventral hernia
Show all 9Show fewer
- Patients who are unable to give informed consent
- Patients who cannot tolerate general anesthesia
- Patients who are pregnant at the time of surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Results of Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair
The purpose of this study is to determine if mesh weight has an impact on postoperative pain, ventral hernia recurrence, incidence of deep wound infection, and overall quality of life following ventral hernia repair with mesh.
Read the detailed description
Approximately five million laparotomies are performed annually in the United States with upwards of 25% of these patients developing a ventral hernia postoperatively. Despite the prevalence of ventral hernias, the surgical approach to these procedures lacks standardization. In fact, nearly 20%-50% of patients undergoing ventral hernia repair (VHR) will experience a hernia recurrence.
There are several factors that can contribute to ventral hernia recurrence. One of these is the use of prosthetic reinforcement. Although previous studies have shown that the use of mesh during VHR significantly decreases the risk of ventral hernia recurrence, guidelines for the ideal prosthetic material remain unknown. In terms of synthetic mesh, there are proponents that argue the value of medium weight material (40-60 g/m2) in order to combat the risk of postoperative deep surgical site infection and minimize the risk of a "stiff abdomen" or chronic pain syndromes.3-5 On the other hand, however, proponents of a heavier weight material ( > 80 g/m2) argue that its tensile strength leads to a long-term, durable hernia repair with decreased risk of hernia recurrence.
To help determine if mesh weight has an impact on postoperative pain, we propose a registry based, randomized clinical trial (RCT) through the Americas Hernia Society Quality Collaborative (AHSQC). The AHSQC is a multicenter, nationwide quality improvement effort with a mission to improve value in hernia care.6 Data are collected prospectively in the routine care of hernia patients for quality improvement purposes. The information collected in the AHSQC offers a natural repository of information that can be used for research, in addition to its quality improvement purpose. The investigators hypothesize that patients who undergo ventral hernia repair with medium weight mesh will have significantly less pain than those patients who undergo ventral hernia repair using heavy weight mesh one year after operation. Both the intended randomization arms of the study are accepted standard of care practices in use by surgeons.
Specific Aim #1: To determine if the use of a medium weight material leads to a decrease in pain intensity at one year following ventral hernia repair.
Specific Aim #2: To determine if there is a difference in ventral hernia recurrence at one year following surgery.
Specific Aim #3: To determine if there is a difference in the rate of deep surgical site infection at 30-days following surgery between the two mesh types.
Specific Aim #4: To determine if there is a difference in the quality of life between the two groups at one year following surgery.
- Conditions
- Ventral Hernia
- Being tested
- Heavy weight Mesh, Medium weight Mesh
- Keywords
- Ventral Hernia Repair, Heavy weight Mesh, Medium weight Mesh
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy weight MeshDevice
Patients will undergo ventral hernia repair with heavy weight mesh.
Medium weight MeshDevice
Patients will undergo ventral hernia repair with medium weight mesh.
| Study group | Role | What they receive |
|---|---|---|
| Heavy weight Mesh | Active comparator | Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh. Receives: Device: Heavy weight Mesh |
| Medium weight Mesh | Active comparator | Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh. Receives: Device: Heavy weight Mesh; Device: Medium weight Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Pain Scores will be measured using the NIH Promis 3A Pain Scale. PROMIS® Pain Intensity 3A is a three-question instrument developed to measure the range of pain experienced in the week prior to assessment. The raw score (3-15) is converted into a T-score where 50 (SD 10) represents the average of people with at least mild pain, higher numbers (maximum 71.8) represent higher than average pain, and the lowest score (30.7) represents no pain.
Measured: One Year Postoperatively
Secondary outcomes (3)
Number of Subjects With Hernia Recurrence
Hernia recurrence will be determined using the Ventral Hernia Recurrence Inventory.
Measured: One Year Postoperatively
Deep Wound Infection
The occurrence of a deep wound infection will be determine based on physical examination and/or computed tomography scanning.
Measured: 30-Days Postoperatively
Quality of Life Scores
Quality of life will be measured using the HerQLes quality of life questionnaire. HerQLes is a twelve-question instrument developed to evaluate quality of life and function as it pertains to the abdominal wall. It is converted into a 0-100 scale with 0 representing poor abdominal wall function, and 100 excellent function.
Measured: One Year Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start14 Mar 2017
- Primary completion28 May 2020
- Study completion28 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Rosen, The Cleveland Clinic
- Investigators
- Michael J Rosen, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082391
- Sponsor's protocol ID
- 16-1643
- Status last verified
- Jun 2022
- First submitted
- 12 Mar 2017
- Last updated
- 14 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD data will not be shared, rather the results of the aggregate groups of patients will be shared.
Publications
Krpata DM, Petro CC, Prabhu AS, Tastaldi L, Zolin S, Fafaj A, Rosenblatt S, Poulose BK, Pierce RA, Warren JA, Carbonell AM, Goldblatt MI, Stewart TG, Olson MA, Rosen MJ. Effect of Hernia Mesh Weights on Postoperative Patient-Related and Clinical Outcomes After Open Ventral Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2021 Dec 1;156(12):1085-1092. doi: 10.1001/jamasurg.2021.4309.
PubMed 34524395
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Results of Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT03082391
- Acronym / sponsor ID
- 16-1643
- Conditions
- Ventral Hernia
- Keywords
- Ventral Hernia Repair, Heavy weight Mesh, Medium weight Mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Posted 22 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if mesh weight has an impact on postoperative pain, ventral hernia recurrence, incidence of deep wound infection, and overall quality of life following ventral hernia repair with mesh.
Detailed description
Approximately five million laparotomies are performed annually in the United States with upwards of 25% of these patients developing a ventral hernia postoperatively. Despite the prevalence of ventral hernias, the surgical approach to these procedures lacks standardization. In fact, nearly 20%-50% of patients undergoing ventral hernia repair (VHR) will experience a hernia recurrence.
There are several factors that can contribute to ventral hernia recurrence. One of these is the use of prosthetic reinforcement. Although previous studies have shown that the use of mesh during VHR significantly decreases the risk of ventral hernia recurrence, guidelines for the ideal prosthetic material remain unknown. In terms of synthetic mesh, there are proponents that argue the value of medium weight material (40-60 g/m2) in order to combat the risk of postoperative deep surgical site infection and minimize the risk of a "stiff abdomen" or chronic pain syndromes.3-5 On the other hand, however, proponents of a heavier weight material ( > 80 g/m2) argue that its tensile strength leads to a long-term, durable hernia repair with decreased risk of hernia recurrence.
To help determine if mesh weight has an impact on postoperative pain, we propose a registry based, randomized clinical trial (RCT) through the Americas Hernia Society Quality Collaborative (AHSQC). The AHSQC is a multicenter, nationwide quality improvement effort with a mission to improve value in hernia care.6 Data are collected prospectively in the routine care of hernia patients for quality improvement purposes. The information collected in the AHSQC offers a natural repository of information that can be used for research, in addition to its quality improvement purpose. The investigators hypothesize that patients who undergo ventral hernia repair with medium weight mesh will have significantly less pain than those patients who undergo ventral hernia repair using heavy weight mesh one year after operation. Both the intended randomization arms of the study are accepted standard of care practices in use by surgeons.
Specific Aim #1: To determine if the use of a medium weight material leads to a decrease in pain intensity at one year following ventral hernia repair.
Specific Aim #2: To determine if there is a difference in ventral hernia recurrence at one year following surgery.
Specific Aim #3: To determine if there is a difference in the rate of deep surgical site infection at 30-days following surgery between the two mesh types.
Specific Aim #4: To determine if there is a difference in the quality of life between the two groups at one year following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy weight Mesh | Active comparator | Device: Heavy weight MeshIntervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh. |
| Medium weight Mesh | Active comparator | Device: Heavy weight Mesh, Device: Medium weight MeshIntervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Will undergo a single-stage, open, retromuscular ventral hernia repair
- CDC Wound Class 1
- Able to achieve midline fascial closure
- Hernia defect width less than or equal to 20 centimeters (measured intraoperatively)
Key exclusion criteria (9 listed)
- Patients who are less than 18 years of age
- Patients who undergo emergent ventral hernia repair
- Patients who undergo laparoscopic or robotic ventral hernia repair
- Patients with CDC Wound Class 2, 3, or 4
- Patients who are unable to undergo successful retromuscular mesh placement or who cannot achieve midline fascial closure
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 |
|---|---|---|
| Heavy weight MeshPatients will undergo ventral hernia repair with heavy weight mesh. | Device | Heavy weight Mesh, Medium weight Mesh |
| Medium weight MeshPatients will undergo ventral hernia repair with medium weight mesh. | Device | Medium weight Mesh |
Primary outcome
Pain Scores
Time frame: One Year Postoperatively
Pain Scores will be measured using the NIH Promis 3A Pain Scale. PROMIS® Pain Intensity 3A is a three-question instrument developed to measure the range of pain experienced in the week prior to assessment. The raw score (3-15) is converted into a T-score where 50 (SD 10) represents the average of people with at least mild pain, higher numbers (maximum 71.8) represent higher than average pain, and the lowest score (30.7) represents no pain.
3 secondary outcomes
Number of Subjects With Hernia Recurrence
Time frame: One Year Postoperatively
Deep Wound Infection
Time frame: 30-Days Postoperatively
Quality of Life Scores
Time frame: One Year Postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34524395Krpata DM, Petro CC, Prabhu AS, Tastaldi L, Zolin S, Fafaj A, Rosenblatt S, Poulose BK, Pierce RA, Warren JA, Carbonell AM, Goldblatt MI, Stewart TG, Olson MA, Rosen MJ. Effect of Hernia Mesh Weights on Postoperative Patient-Related and Clinical Outcomes After Open Ventral Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2021 Dec 1;156(12):1085-1092. doi: 10.1001/jamasurg.2021.4309.
- Individual participant dataSharing planned: No. IPD 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.
Michael J Rosen, MD 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 Heavy weight Mesh and Medium weight Mesh in people with Ventral 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 7 inclusion and 9 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 14 Jul 2022. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Scores (time frame: One Year Postoperatively). 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 NCT03082391, 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 14 Jul 2022.