Hiatal HerniaPhase 4NCT02242526
Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia
A Phase 4 study testing Parietex™ Composite Hiatal Mesh, North Haven, CT and Biodesign™ Surgisis® Graft, Cook Medical, Bloomington in people with Hiatal Hernia, run by Stony Brook University at 1 site in United States.
Trial summary
The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hiatal Hernia
- What is being tested?
- Parietex™ Composite Hiatal Mesh, North Haven, CT and Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2020
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female gender
- Age>18 years
- Absence of chronic medical conditions that will affect the quality of life survey, such as fibromyalgia, SLE, Crohn's disease, etc.
- Able to give informed consent
- Able and willing to participate in follow-up evaluations
- Upper GI with a documented hiatal hernia greater than 5cm
- Paraesophageal hernia with clinically relevant symptoms such as heartburn, chest pain, regurgitation, dysphagia, postprandial abdominal pain, shortness of breath, or early satiety.
Who cannot join
- Previous surgery of the esophagus and/or the stomach
- Emergent operation for acute gastric volvulus or strangulation
- Biopsy consistent with malignancy
- Body Mass Index (BMI) over 35kg/m2
- Inability to perform primary closure of crura
- Active smoking
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Aurora Pryor, MD, 631-444-7788, aurora.pryor@stonybrookmedicine.edu
Shabana Humayon, MD, 6316380292, shabana.humayon@stonybrookmedicine.edu
About this study
The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.
Read the detailed description
Patients will be randomized to either a synthetic (light weight synthetic or biologic (small intestinal submucosa ) mesh group. Endpoints will be measured up to 5 years for the study as a whole, at 6 months and at 60 months. Prior to and following laparoscopic paraesophageal hernia repair, patients will be followed with both subjective and objective measures. Subjective evaluation will include symptomatic/quality of life assessment at 1-, 6-, 24-, and 60- month periods; objective evaluation will include Upper GI study /pH probe study for symptomatic patients and for all patients at 6 and 60 months. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.
- Conditions
- Hiatal Hernia
- Being tested
- Parietex™ Composite Hiatal Mesh, North Haven, CT, Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
- Keywords
- hiatal hernia, recurrence, biologic mesh, synthetic mesh
- Medical subject headings
- Hernia, Hiatal, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parietex™ Composite Hiatal Mesh, North Haven, CTDevice
Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.
Biodesign™ Surgisis® Graft, Cook Medical, BloomingtonDevice
Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.
| Study group | Role | What they receive |
|---|---|---|
| Parietex™ Composite Hiatal Mesh, North Haven, CT | Active comparator | Synthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair. Receives: Device: Parietex™ Composite Hiatal Mesh, North Haven, CT; Device: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington |
| Biodesign™ Surgisis® Graft, Cook Medical, Bloomington | Active comparator | Biologic mesh Biodesign™ Surgisis® Graft Reinforcement in Hiatal, Cook Medical, Bloomington, IN which will be placed for repair of hiatal hernia Receives: Device: Parietex™ Composite Hiatal Mesh, North Haven, CT; Device: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess for reappearance of hiatal hernia and reflux
Change at 6 and 60 months will be assessed by pH and Upper GI (endoscopy) studies to assess for reappearance of hiatal hernia and reflux.
Measured: 6 months, 60 months
Secondary outcomes (1)
Quality of Life questionnaire
Quality of life questionnaire containing 36 questions
Measured: Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hiatal 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242526
- Sponsor's protocol ID
- SB-568818
- Status last verified
- Oct 2018
- First submitted
- 3 Sep 2014
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia
- ClinicalTrials.gov ID
- NCT02242526
- Acronym / sponsor ID
- SB-568818
- Conditions
- Hiatal Hernia
- Keywords
- hiatal hernia, recurrence, biologic mesh, synthetic mesh
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 17 Sep 2014 (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.
The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.
Detailed description
Patients will be randomized to either a synthetic (light weight synthetic or biologic (small intestinal submucosa ) mesh group. Endpoints will be measured up to 5 years for the study as a whole, at 6 months and at 60 months. Prior to and following laparoscopic paraesophageal hernia repair, patients will be followed with both subjective and objective measures. Subjective evaluation will include symptomatic/quality of life assessment at 1-, 6-, 24-, and 60- month periods; objective evaluation will include Upper GI study /pH probe study for symptomatic patients and for all patients at 6 and 60 months. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parietex™ Composite Hiatal Mesh, North Haven, CT | Active comparator | Device: Parietex™ Composite Hiatal Mesh, North Haven, CT, Device: Biodesign™ Surgisis® Graft, Cook Medical, BloomingtonSynthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair. |
| Biodesign™ Surgisis® Graft, Cook Medical, Bloomington | Active comparator | Device: Parietex™ Composite Hiatal Mesh, North Haven, CT, Device: Biodesign™ Surgisis® Graft, Cook Medical, BloomingtonBiologic mesh Biodesign™ Surgisis® Graft Reinforcement in Hiatal, Cook Medical, Bloomington, IN which will be placed for repair of hiatal hernia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female gender
- Age>18 years
- Absence of chronic medical conditions that will affect the quality of life survey, such as fibromyalgia, SLE, Crohn's disease, etc.
- Able to give informed consent
- Able and willing to participate in follow-up evaluations
Key exclusion criteria (6 listed)
- Previous surgery of the esophagus and/or the stomach
- Emergent operation for acute gastric volvulus or strangulation
- Biopsy consistent with malignancy
- Body Mass Index (BMI) over 35kg/m2
- Inability to perform primary closure of crura
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 |
|---|---|---|
| Parietex™ Composite Hiatal Mesh, North Haven, CTParietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair. | Device | Biodesign™ Surgisis® Graft, Cook Medical, Bloomington, Parietex™ Composite Hiatal Mesh, North Haven, CT |
| Biodesign™ Surgisis® Graft, Cook Medical, BloomingtonBiodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair. | Device | Biodesign™ Surgisis® Graft, Cook Medical, Bloomington, Parietex™ Composite Hiatal Mesh, North Haven, CT |
Primary outcome
Assess for reappearance of hiatal hernia and reflux
Time frame: 6 months, 60 months
Change at 6 and 60 months will be assessed by pH and Upper GI (endoscopy) studies to assess for reappearance of hiatal hernia and reflux.
1 secondary outcome
Quality of Life questionnaire
Time frame: Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
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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.
Stony Brook University Hospital
Stony Brook, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Parietex™ Composite Hiatal Mesh, North Haven, CT and Biodesign™ Surgisis® Graft, Cook Medical, Bloomington in people with Hiatal Hernia, run by Stony Brook University 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 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: status not confirmed, as of the sponsor's last update on 15 Oct 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess for reappearance of hiatal hernia and reflux (time frame: 6 months, 60 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 15 Oct 2018.