HerniaSeprameshNCT01305473

A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite

An observational study of Hernia, run by C. R. Bard at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study. The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hernia
How many people: 90 participants
Where: 1 siteUnited States
Study dates: Aug 2010to Feb 2011
Phase: Observational
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects who have been treated with Sepramesh at least 12 months before starting in this study.

Who may be able to join

Have undergone a laparoscopic ventral repair utilizing Sepramesh at least 12 months before starting in this study.
Have signed an Informed Consent Form (ICF).

Who cannot join

Underwent implantation of Sepramesh for any reason other than ventral hernia repair.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cornerstone Medical Center
Centerville, Ohio, 45459

Other trials in United States

About this study

Official title: A Single Arm, Single-Center, Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite

This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study.

The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.

Conditions: Hernia
Medical subject headings: Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01305473
Study group	Role	What they receive
Sepramesh Group		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.
A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure.
Measured: 12 months or greater (average follow-up time of 3 years; range 13-65 months)

Secondary outcomes (3)

Complications in Subjects With Hernias Repaired With Sepramesh.
Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit (that is, the protocol specified postoperative visit for conducting a physical examination).
Measured: 12 months or greater (average follow-up time of 3 years; range 13-65 months)
Procedural Time for Sepramesh Placement.
Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).
Measured: Day 0
Recovery Time Associated With Hernias Repaired With Sepramesh.
Recovery time will be defined as the time it took for the subject to return to work.
Measured: 12 months or greater (average follow-up time of 3 years; range 13-65 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Feb 2011

First posted28 Feb 2011 (estimated)
Study startAug 2010
Primary completionFeb 2011
Study completionFeb 2011

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.
Other trials for HerniaStudies of the same condition, open and under way.
More trials run by C. R. BardThe 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: Cross-sectional
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01305473
Sponsor's protocol ID: DVL-HE007
Acronym: Sepramesh
Status last verified: Jul 2012
First submitted: 25 Feb 2011
Last updated: 1 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia

All Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm, Single-Center, Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite
ClinicalTrials.gov ID: NCT01305473
Acronym / sponsor ID: Sepramesh / DVL-HE007
Conditions: Hernia
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 28 Feb 2011 (estimated)
Results: Posted 18 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Sepramesh Group	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects who have been treated with Sepramesh at least 12 months before starting in this study.

Key inclusion criteria (2 listed)

Have undergone a laparoscopic ventral repair utilizing Sepramesh at least 12 months before starting in this study.
Have signed an Informed Consent Form (ICF).

Key exclusion criteria (1 listed)

Underwent implantation of Sepramesh for any reason other than ventral hernia repair.

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 Rate of Hernias Post Repair With Sepramesh.
Time frame: 12 months or greater (average follow-up time of 3 years; range 13-65 months)
A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure.

3 secondary outcomes

Complications in Subjects With Hernias Repaired With Sepramesh.
Time frame: 12 months or greater (average follow-up time of 3 years; range 13-65 months)
Procedural Time for Sepramesh Placement.
Time frame: Day 0
Recovery Time Associated With Hernias Repaired With Sepramesh.
Time frame: 12 months or greater (average follow-up time of 3 years; range 13-65 months)

Results and safety

Results posted to the registry on 18 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sepramesh Group	90	90

Primary outcome: Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.

Time frame: 12 months or greater (average follow-up time of 3 years; range 13-65 months). Number. Unit: participants

Measure	Sepramesh Group n = 90
Value	1

Population analysed: All enrolled subjects were included in the analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Protocol defined adverse events were collected for a period of 12 months or greater, with the collection period beginning at the time of the index procedure and ending at the time of the subject's last study contact.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sepramesh Group	3 of 90 (3.3%)	1 of 90 (1.1%)	Not reported

Limitations and caveats (from the sponsor): Study was designed to use existing data. Limitations include: limited data generalizability given the retrospective, single center study design; incomplete documentation did not permit evaluation of recovery time as pre-specified secondary endpoint.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hernia

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia

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.

Andrew L Archer, MD principal investigator

Providence Medical Group and Cornerstone Medical Center

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 C. R. Bard 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 1 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 1 Aug 2012. 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 18 Jul 2012). 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?

Hernia Recurrence Rate of Hernias Post Repair With Sepramesh. (time frame: 12 months or greater (average follow-up time of 3 years; range 13-65 months)). 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 NCT01305473.

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 Aug 2012.