Esophageal HerniaStratticeNCT01678157
Use of Strattice Mesh in Paraesophageal Hernia Surgery
An observational study of Esophageal Hernia and Hernia, Esophageal, run by University of Nebraska at 1 site in United States.
Trial summary
The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Esophageal Hernia, Hernia, Esophageal, Hernia, Paraesophageal
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2012to 1 May 2015
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults over 19 years of age with paraesophageal hernia greater than 5 cm.
Who may be able to join
- Documented symptomatic paraesophageal hernia.
- Greater than 5 cm hiatal hernia on upper gastrointestinal study.
- Evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum.
- Significant symptoms or signs of a paraesophageal hernia including but not limited to heartburn, dysphagia, chest pain, shortness of breath, postprandial abdominal pain, early satiety, odynophagia, or chronic anemia.
- Consenting adult 19 years of age or older
- Must be able to participate in follow-up evaluation.
- Free of cognitive impairment
Who cannot join
- Children and adolescents (19 years of age or younger).
- Pregnant and breast feeding patients.
- Vulnerable subjects such as pregnant women, children less than 19 years age, and decisionally impaired persons.
- Patients with previous operation of the esophagus or stomach.
- Patients with associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of life assessment (e.g. Crohn's disease).
- Patients with emergent operation for acute gastric volvulus.
- Patients with known sensitivity to porcine material.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Use of Strattice in the Laparoscopic Suture Closure of a Paraesophageal Hernia
The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair.
Read the detailed description
Prosthetic reinforcements reduce recurrence rates; the choice of optimal prosthetic, either synthetic or biosynthetic, for crural reinforcement is controversial. The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair. Strattice is a commonly used mesh in hernia repair. 35 adult (>19 years of age) patients will be selected based on inclusion and exclusion criteria. Patients who meet the criteria will be enrolled in the study. Information related to recurrence rates based on follow-up visits will be analyzed to determine the efficacy of Strattice in the prevention of large hernia recurrence.
- Conditions
- Esophageal Hernia, Hernia, Esophageal, Hernia, Paraesophageal, Hiatal Hernia, Paraesophageal Hiatal Hernia, Sliding Esophageal Hernia
- Keywords
- Esophageal Hernia, Hernia, Esophageal, Hernia, Paraesophageal, Hiatal Hernia, Paraesophageal Hiatal Hernia, Sliding Esophageal Hernia, Sliding Hiatal Hernia
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Documented symptomatic paraesophageal hernia | 1. Documented symptomatic paraesophageal hernia. 2. Greater than 5 cm hiatal hernia on upper gastrointestinal study. 3. Evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum. 4. Significant symptoms or signs of a paraesophageal hernia including but not limited to heartburn,dysphagia, chest pain, shortness of breath, postprandial abdominal pain, early satiety, odynophagia, or chronic anemia. 5. Consenting adult 19 years of age or older 6. Must be able to participate in follow-up evaluation. 7. Free of cognitive impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence
A barium swallow test with x-rays will be performed to assess recurrence of hernia, if any
Measured: 1 year post-surgery
Secondary outcomes (1)
Recurrence of reflux symptoms
Patients will be evaluated for recurrence of reflux symptoms at the three postoperative visits. If recurrence warrants, a barium swallow with x-rays will be performed prior to 1-year primary outcome barium swallow test
Measured: 2 weeks, 6 months and 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study start5 Mar 2012
- Primary completion1 May 2015
- Study completion1 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal HerniaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- LifeCell
- Responsible party
- Sponsor
- Investigators
- Dmitry Oleynikov, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678157
- Sponsor's protocol ID
- 0314-11-FB
- Acronym
- Strattice
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2012
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Strattice in the Laparoscopic Suture Closure of a Paraesophageal Hernia
- ClinicalTrials.gov ID
- NCT01678157
- Acronym / sponsor ID
- Strattice / 0314-11-FB
- Conditions
- Esophageal Hernia, Hernia, Esophageal, Hernia, Paraesophageal, Hiatal Hernia, Paraesophageal Hiatal Hernia, Sliding Esophageal Hernia
- Keywords
- Esophageal Hernia, Hernia, Esophageal, Hernia, Paraesophageal, Hiatal Hernia, Paraesophageal Hiatal Hernia, Sliding Esophageal Hernia, Sliding Hiatal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- LifeCell
- Study start
- 5 Mar 2012 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 1 May 2015 (actual)
- First posted
- 3 Sep 2012 (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 objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair.
Detailed description
Prosthetic reinforcements reduce recurrence rates; the choice of optimal prosthetic, either synthetic or biosynthetic, for crural reinforcement is controversial. The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair. Strattice is a commonly used mesh in hernia repair. 35 adult (>19 years of age) patients will be selected based on inclusion and exclusion criteria. Patients who meet the criteria will be enrolled in the study. Information related to recurrence rates based on follow-up visits will be analyzed to determine the efficacy of Strattice in the prevention of large hernia recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Documented symptomatic paraesophageal hernia | – | –1. Documented symptomatic paraesophageal hernia. 2. Greater than 5 cm hiatal hernia on upper gastrointestinal study. 3. Evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum. 4. Significant symptoms or signs of a paraesophageal hernia including but not limited to heartburn,dysphagia, chest pain, shortness of breath, postprandial abdominal pain, early satiety, odynophagia, or chronic anemia. 5. Consenting adult 19 years of age or older 6. Must be able to participate in follow-up evaluation. 7. Free of cognitive impairment |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over 19 years of age with paraesophageal hernia greater than 5 cm.
Key inclusion criteria (7 listed)
- Documented symptomatic paraesophageal hernia.
- Greater than 5 cm hiatal hernia on upper gastrointestinal study.
- Evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum.
- Significant symptoms or signs of a paraesophageal hernia including but not limited to heartburn, dysphagia, chest pain, shortness of breath, postprandial abdominal pain, early satiety, odynophagia, or chronic anemia.
- Consenting adult 19 years of age or older
Key exclusion criteria (7 listed)
- Children and adolescents (19 years of age or younger).
- Pregnant and breast feeding patients.
- Vulnerable subjects such as pregnant women, children less than 19 years age, and decisionally impaired persons.
- Patients with previous operation of the esophagus or stomach.
- Patients with associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of life assessment (e.g. Crohn's disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hernia recurrence
Time frame: 1 year post-surgery
A barium swallow test with x-rays will be performed to assess recurrence of hernia, if any
1 secondary outcome
Recurrence of reflux symptoms
Time frame: 2 weeks, 6 months and 1 year post-surgery
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 6 Sep 2023.
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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.
Dmitry Oleynikov, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Hernia and Hernia, Esophageal, run by University of Nebraska 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 7 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 6 Sep 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?
Hernia recurrence (time frame: 1 year post-surgery). 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 6 Sep 2023.