Hiatal HerniaPhase 2/3NCT02328248
Usage of Biological Patch Versus Plastic in the Laparoscopic Repair of Hiatal Hernias
A Phase 2/3 study testing Biological patch in people with Hiatal Hernia, run by Xijing Hospital of Digestive Diseases.
Trial summary
The purpose of this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hiatal Hernia
- What is being tested?
- Biological patch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2016
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Hiatal hernia
- Consistent with operation indications throughout the guideline of hiatal hernia by the Chinese Medical Association in 2003
- randomly select patch agreed by patients and family members
Who cannot join
- Poor general condition
- severe organ dysfunction
- No-tolerate anesthesia
- No-suitable for operation
- Emergency operation needed
- Serious adverse events appeared during the operation
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- Sever intraperitoneal adhesion existed
- glucocorticoid with long-term use
- immunocompromised patients
- spirit disease patients
- automatically exit
- women who pregnant
About this study
Official title: Randomized Control Trial (RCT) That the Usage With Biological Patch Versus Plastic in the Laparoscopic Repair
The purpose of this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic.
Read the detailed description
observation indicator:
- incidence rate of complications,
- postoperative hospital stay
- readmission rate in 1st month after operation
- recurrence rate after operation
- hospitalization costs
- Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation
- Conditions
- Hiatal Hernia
- Being tested
- Biological patch
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological patchProcedure or surgery
Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically
| Study group | Role | What they receive |
|---|---|---|
| Biological patch | Experimental | Use biological patch (Biodesign Surgisis Tissue Graft from Cook Biotech Incorporated) to repair hiatal hernia laparoscopically Receives: Procedure: Biological patch |
| Plastic patch | Placebo comparator | Use plastic patch (Parietex Composite from Sofradim Production) to repair hiatal hernia laparoscopically |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of complications in all case
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaonan Liu, Xijing Hospital of Digestive Diseases
- Investigators
- Xiaonan Liu, Ph.D, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328248
- Sponsor's protocol ID
- HH-001
- Status last verified
- Dec 2014
- First submitted
- 28 Nov 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial (RCT) That the Usage With Biological Patch Versus Plastic in the Laparoscopic Repair
- ClinicalTrials.gov ID
- NCT02328248
- Acronym / sponsor ID
- HH-001
- Conditions
- Hiatal Hernia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Dec 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 purpose of this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic.
Detailed description
observation indicator:
- incidence rate of complications,
- postoperative hospital stay
- readmission rate in 1st month after operation
- recurrence rate after operation
- hospitalization costs
- Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological patch | Experimental | Procedure: Biological patchUse biological patch (Biodesign Surgisis Tissue Graft from Cook Biotech Incorporated) to repair hiatal hernia laparoscopically |
| Plastic patch | Placebo comparator | –Use plastic patch (Parietex Composite from Sofradim Production) to repair hiatal hernia laparoscopically |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Hiatal hernia
- Consistent with operation indications throughout the guideline of hiatal hernia by the Chinese Medical Association in 2003
- randomly select patch agreed by patients and family members
Key exclusion criteria (12 listed)
- Poor general condition
- severe organ dysfunction
- No-tolerate anesthesia
- No-suitable for operation
- Emergency operation needed
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 |
|---|---|---|
| Biological patchUse biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically | Procedure or surgery | Biological patch |
Primary outcome
The incidence of complications in all case
Time frame: five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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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.
Xiaonan Liu, Ph.D study chair
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Biological patch in people with Hiatal Hernia, run by Xijing Hospital of Digestive Diseases.
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 3 inclusion and 12 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 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
The incidence of complications in all case (time frame: five years). 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 31 Dec 2014.