HerniaNCT00272922
Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)
A study testing hernia repair in people with Hernia and Paraesophageal Hernia, run by Cook Group Incorporated at 1 site in United States.
Trial summary
The purpose of this randomized study is to determine whether a type of mesh derived from a layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus standard surgical suture repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Paraesophageal Hernia
- What is being tested?
- hernia repair
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Jul 2006
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Documented symptomatic paraesophageal hernia
- Ability to participate in follow-up evaluation
- Has a telephone
- Free of cognitive or speech impairment
Who cannot join
- Patients requiring intra-operative conversion to an open procedure
- Unable to close the crura primarily
- Short esophagus that requires the surgeon to perform a lengthening procedure
- Previous operation of the esphagus or stomach
- Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of like assessment
- Intraoperative full-thickness perforation of the esophagus
- Emergent operation for acute volvulus
- Ineffective peristalsis defined as average amplitude of peristalsis less than 30 mmHg or < 70% propagation of peristaltic waves in the distal esophagus
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this randomized study is to determine whether a type of mesh derived from a layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus standard surgical suture repair.
- Conditions
- Hernia, Paraesophageal Hernia
- Being tested
- hernia repair
- Keywords
- Biomaterials, Paraesophageal Hernia, Laparoscopy
- Medical subject headings
- Hernia, Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hernia repairDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startJul 2002
- Study completionJul 2006
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Brant K Oelschlager, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272922
- Sponsor's protocol ID
- 02-1931-A-01 (Institution #)
- Status last verified
- Oct 2007
- First submitted
- 4 Jan 2006
- Last updated
- 18 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)
- ClinicalTrials.gov ID
- NCT00272922
- Acronym / sponsor ID
- 02-1931-A-01 (Institution #)
- Conditions
- Hernia, Paraesophageal Hernia
- Keywords
- Biomaterials, Paraesophageal Hernia, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Study completion
- Jul 2006 (actual)
- First posted
- 9 Jan 2006 (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 purpose of this randomized study is to determine whether a type of mesh derived from a layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus standard surgical suture repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Documented symptomatic paraesophageal hernia
- Ability to participate in follow-up evaluation
- Has a telephone
- Free of cognitive or speech impairment
Key exclusion criteria (8 listed)
- Patients requiring intra-operative conversion to an open procedure
- Unable to close the crura primarily
- Short esophagus that requires the surgeon to perform a lengthening procedure
- Previous operation of the esphagus or stomach
- Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of like assessment
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 |
|---|---|---|
| hernia repair | Device | – |
Primary outcome
Not reported in the source record.
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 18 Oct 2007.
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.
Brant K Oelschlager, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hernia repair in people with Hernia and Paraesophageal Hernia, run by Cook Group Incorporated 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 5 inclusion and 8 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 18 Oct 2007. 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.
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 18 Oct 2007.