Incarcerated Inguinal HerniaPhase 2/3NCT02469142
Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions
A Phase 2/3 study testing ADM tension-free hernia reparation in people with Incarcerated Inguinal Hernia, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
Incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often prone to intestinal necrosis and acute peritonitis.Using traditional tension hernia reparation, the recurrence rate were as high as 30%. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Incarcerated Inguinal Hernia
- What is being tested?
- ADM tension-free hernia reparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2019
- 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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of incarcerated hernia
- randomly select patch agreed by patients and family members
Who cannot join
- severe organ dysfunction
- No-tolerate anesthesia
- No-suitable for operation
- glucocorticoid with long-term use
- Sever intraperitoneal adhesion existed
- spirit disease patients
- automatically exit
Trial locations and contacts
1 site in 1 country.
About this study
Incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often prone to intestinal necrosis and acute peritonitis.Using traditional tension hernia reparation, the recurrence rate were as high as 30%. In recent years, biological materials especially acellular matrix materials (Acellular Dermal Matrix, ADM) in resisting the infection, has become a research hotspot. In the project, the investigators try to address the role of ADM in incarcerated inguinal hernia patients.
Read the detailed description
observation indicator:
- recurrence rate after operation
- incidence rate of complications
- postoperative hospital stay
- 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
- Incarcerated Inguinal Hernia
- Being tested
- ADM tension-free hernia reparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADM tension-free hernia reparationProcedure or surgery
Use ADM as opposed to nothing to repair incarcerated inguinal hernia
| Study group | Role | What they receive |
|---|---|---|
| ADM tension-free hernia reparation | Experimental | Use ADM to repair incarcerated inguinal hernia by tension-free Receives: Procedure: ADM tension-free hernia reparation |
| traditional tension hernia reparation | Placebo comparator | Just repair incarcerated inguinal hernia by nothing in tension condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
the recurrence rate after operation
Measured: ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incarcerated Inguinal 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
- 100 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, MD, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469142
- Sponsor's protocol ID
- ADM001
- Status last verified
- Jun 2015
- First submitted
- 4 Jan 2015
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saeter AH, Fonnes S, Li S, Rosenberg J, Andresen K. Mesh versus non-mesh for emergency groin hernia repair. Cochrane Database Syst Rev. 2023 Nov 27;11(11):CD015160. doi: 10.1002/14651858.CD015160.pub2.
PubMed 38009575
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions
- ClinicalTrials.gov ID
- NCT02469142
- Acronym / sponsor ID
- ADM001
- Conditions
- Incarcerated Inguinal Hernia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Jun 2015 (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.
Incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often prone to intestinal necrosis and acute peritonitis.Using traditional tension hernia reparation, the recurrence rate were as high as 30%. In recent years, biological materials especially acellular matrix materials (Acellular Dermal Matrix, ADM) in resisting the infection, has become a research hotspot. In the project, the investigators try to address the role of ADM in incarcerated inguinal hernia patients.
Detailed description
observation indicator:
- recurrence rate after operation
- incidence rate of complications
- postoperative hospital stay
- 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 |
|---|---|---|
| ADM tension-free hernia reparation | Experimental | Procedure: ADM tension-free hernia reparationUse ADM to repair incarcerated inguinal hernia by tension-free |
| traditional tension hernia reparation | Placebo comparator | –Just repair incarcerated inguinal hernia by nothing in tension condition |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of incarcerated hernia
- randomly select patch agreed by patients and family members
Key exclusion criteria (7 listed)
- severe organ dysfunction
- No-tolerate anesthesia
- No-suitable for operation
- glucocorticoid with long-term use
- Sever intraperitoneal adhesion existed
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 |
|---|---|---|
| ADM tension-free hernia reparationUse ADM as opposed to nothing to repair incarcerated inguinal hernia | Procedure or surgery | ADM tension-free hernia reparation |
Primary outcome
the recurrence rate after operation
Time frame: ten years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
- Derived from this study: PubMed 38009575Saeter AH, Fonnes S, Li S, Rosenberg J, Andresen K. Mesh versus non-mesh for emergency groin hernia repair. Cochrane Database Syst Rev. 2023 Nov 27;11(11):CD015160. doi: 10.1002/14651858.CD015160.pub2.
Related trials for Incarcerated Inguinal Hernia
Not yet recruiting
Bassini Repair Versus Desarda Technique in Urgent Complicated Inguinal Hernia Repair
Inguinal Hernia, Incarcerated Inguinal 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.
xiaonan liu, MD study chair
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ADM tension-free hernia reparation in people with Incarcerated Inguinal Hernia, run by Xijing Hospital of Digestive Diseases at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 11 Jun 2015. 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 China. 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. 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 recurrence rate after operation (time frame: ten years). 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 NCT02469142, which also lists 1 linked publication.
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 11 Jun 2015.