HerniaNCT04534920
Comparison of Sample Characteristics Between Subjects Who Received Strattice Mesh for Abdominal Wall Reconstruction
An observational study of Hernia, run by New York Medical College at 1 site in United States.
Trial summary
Two different datasets from Institutional Review Board (IRB) approved studies L#12,083 and L#12,086 will be used to compare the sample characteristics between subjects who received Strattice mesh for abdominal wall reconstruction at Westchester Medical Center and Americas Hernia Society Quality Collaborative (AHSQC)… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hernia
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 13 Dec 2021
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All male and female subjects who were between 18 to 85 years old, who had complex abdominal wall reconstruction at Westchester Medical Center and received biologic mesh during 1/1/2011 to 12/31/2018 are included in this study.
Who may be able to join
- Subjects 18 to 85 years old
- Subjects who had complex abdominal wall reconstruction and received biologic mesh are included in the study
Who cannot join
- Subjects below 18 years of age and above the age of 85 years are excluded.
- Any hernia repair not using biologic mesh are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Westchester Medical center
Valhalla, New York, 10595
About this study
Official title: Comparison of Sample Characteristics Between the Subjects Who Received Strattice Mesh for Abdominal Wall Reconstruction at Westchester Medical Center vs Americas Hernia Society Quality Collaborative (AHSQC) Registry Dataset
Two different datasets from Institutional Review Board (IRB) approved studies L#12,083 and L#12,086 will be used to compare the sample characteristics between subjects who received Strattice mesh for abdominal wall reconstruction at Westchester Medical Center and Americas Hernia Society Quality Collaborative (AHSQC) registry.
Read the detailed description
Abdominal wall defects or hernias are commonly seen after open surgery performed electively or under emergent conditions. During the last decade numerous advances have been made in the management of patients with abdominal wall defects. These defects are repaired by various surgical techniques including mesh repair (synthetic vs. biologic), primary repair, etc. However, the outcomes of patients after these injuries are highly variable and many of these patients suffer from in-hospital complications, mesh infections requiring explantation, and recurrence. Various factors play a role in the final outcome of the patient. These include factors associated with the reasons for initial surgery or disease (trauma or emergency general surgery), patient demographics (age, gender, co-morbidities), preoperative features (hemoglobin and other biochemical indicators, surgical technique used during the repair and use of repair (onlay, inlay, retro rectus) and the types of mesh used.
Study Design Two different datasets from Institutional Review Board (IRB) approved studies L#12,083 and L#12,086 will be used to compare the sample characteristics between subjects who received Strattice mesh for abdominal wall reconstruction at Westchester Medical Center and Americas Hernia Society Quality Collaborative (AHSQC) registry.
Primary Objective: To determine the degree to which our sample of Strattice® recipients resemble AHSQC Strattice® recipients.
Study Summary:
This study involves two different datasets from our existing studies L#12083 and L#12,086 which are approved by New York Medical College, IRB on 6/14/2017and 7/7/2017 respectively.
Study L#12,083 is a retrospective data collection of subjects who had abdominal wall reconstruction and received Strattice mesh during 1/1/2011 to 12/31/2018 at Westchester Medical Center. A total of 105 records from this study will be used for comparison study. Study L#12086 is a prospective study of subjects who had abdominal wall reconstruction using biological mesh. A total of 77 records will be used from this study. From both the studies combined we have about a total of 182 records of extracted data and same data variables will be used to compare with AHSQC registry. The data that will be compared includes preoperative info, hospital course, complications, re-hospitalizations and 2weeks follow-up.
Research Subject Population:
Number of Subjects Total of 182 records met the inclusion criteria and data has been collected.
Gender of Subjects There will be no gender based restrictions for this study.
Age of Subjects Subjects 18 to 85 years old will be included in this study.
- Conditions
- Hernia
- Medical subject headings
- Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of sample characteristics between WMC Strattice® recipients and AHSQC Strattice® recipients
Comorbidities, operative details, mesh size and location, number of drains, surgical site infection and readmissions.
Measured: from 1/1/2011 to 12/31/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start27 Jul 2020
- Primary completion13 Dec 2021 (estimated)
- Study completion13 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rifat Latifi, New York Medical College
- Investigators
- Rifat Latifi, MD, Principal investigator, Chairman Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534920
- Sponsor's protocol ID
- 14073
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no plan
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sample Characteristics Between the Subjects Who Received Strattice Mesh for Abdominal Wall Reconstruction at Westchester Medical Center vs Americas Hernia Society Quality Collaborative (AHSQC) Registry Dataset
- ClinicalTrials.gov ID
- NCT04534920
- Acronym / sponsor ID
- 14073
- Conditions
- Hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (actual)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 13 Dec 2021 (estimated)
- Study completion
- 13 Dec 2021 (estimated)
- First posted
- 1 Sep 2020 (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.
Two different datasets from Institutional Review Board (IRB) approved studies L#12,083 and L#12,086 will be used to compare the sample characteristics between subjects who received Strattice mesh for abdominal wall reconstruction at Westchester Medical Center and Americas Hernia Society Quality Collaborative (AHSQC) registry.
Detailed description
Abdominal wall defects or hernias are commonly seen after open surgery performed electively or under emergent conditions. During the last decade numerous advances have been made in the management of patients with abdominal wall defects. These defects are repaired by various surgical techniques including mesh repair (synthetic vs. biologic), primary repair, etc. However, the outcomes of patients after these injuries are highly variable and many of these patients suffer from in-hospital complications, mesh infections requiring explantation, and recurrence. Various factors play a role in the final outcome of the patient. These include factors associated with the reasons for initial surgery or disease (trauma or emergency general surgery), patient demographics (age, gender, co-morbidities), preoperative features (hemoglobin and other biochemical indicators, surgical technique used during the repair and use of repair (onlay, inlay, retro rectus) and the types of mesh used.
Study Design Two different datasets from Institutional Review Board (IRB) approved studies L#12,083 and L#12,086 will be used to compare the sample characteristics between subjects who received Strattice mesh for abdominal wall reconstruction at Westchester Medical Center and Americas Hernia Society Quality Collaborative (AHSQC) registry.
Primary Objective: To determine the degree to which our sample of Strattice® recipients resemble AHSQC Strattice® recipients.
Study Summary:
This study involves two different datasets from our existing studies L#12083 and L#12,086 which are approved by New York Medical College, IRB on 6/14/2017and 7/7/2017 respectively.
Study L#12,083 is a retrospective data collection of subjects who had abdominal wall reconstruction and received Strattice mesh during 1/1/2011 to 12/31/2018 at Westchester Medical Center. A total of 105 records from this study will be used for comparison study. Study L#12086 is a prospective study of subjects who had abdominal wall reconstruction using biological mesh. A total of 77 records will be used from this study. From both the studies combined we have about a total of 182 records of extracted data and same data variables will be used to compare with AHSQC registry. The data that will be compared includes preoperative info, hospital course, complications, re-hospitalizations and 2weeks follow-up.
Research Subject Population:
Number of Subjects Total of 182 records met the inclusion criteria and data has been collected.
Gender of Subjects There will be no gender based restrictions for this study.
Age of Subjects Subjects 18 to 85 years old will be included in this study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All male and female subjects who were between 18 to 85 years old, who had complex abdominal wall reconstruction at Westchester Medical Center and received biologic mesh during 1/1/2011 to 12/31/2018 are included in this study.
Key inclusion criteria (2 listed)
- Subjects 18 to 85 years old
- Subjects who had complex abdominal wall reconstruction and received biologic mesh are included in the study
Key exclusion criteria (2 listed)
- Subjects below 18 years of age and above the age of 85 years are excluded.
- Any hernia repair not using biologic mesh are excluded.
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
comparison of sample characteristics between WMC Strattice® recipients and AHSQC Strattice® recipients
Time frame: from 1/1/2011 to 12/31/2018
Comorbidities, operative details, mesh size and location, number of drains, surgical site infection and readmissions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: Undecided. no plan
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North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
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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.
Rifat Latifi, MD principal investigator
Chairman Department of Surgery
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 Hernia, run by New York Medical College 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 2 inclusion and 2 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 1 Sep 2021. 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?
Results are not available in the source record.
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?
comparison of sample characteristics between WMC Strattice® recipients and AHSQC Strattice® recipients (time frame: from 1/1/2011 to 12/31/2018). 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 1 Sep 2021.