Inguinal HerniaDYSLOHNCT05706662
Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.
A study testing inguinal hernia repair with mesh in people with Inguinal Hernia, run by University of Palermo at 1 site in Italy.
Trial summary
Evaluating the outcomes of patients undergoing open anterior inguinal hernioplasty comparing two different techniques: Lichtenstein/plug and mesh and ProFlor. The outcomes of these two groups of patients, respectively the Lichtenstein inguinal hernia repair with static flat mesh and the defect obliteration with 3D… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- inguinal hernia repair with mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 31 Dec 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients were individuals aged between 18 and 85 years old, competent to give consent, affected by clinically relevant primary inguinal hernia scheduled to undergo elective inguinal hernia repair and eligible for outpatient surgical procedure with local anesthesia.
Who cannot join
- Recurrent inguinal hernia
- Incarcerated inguinal hernia
- Hernia not in the inguinal area
- Signs of obvious local or systemic infection
- ASA score > 4
- Presenting with unstable angina or NYHA class of IV
Show all 13Show fewer
- Pregnant
- Active drug user
- Immunosuppression, chemotherapy
- Chronic renal insufficiency
- Abdominal ascites
- Infection in area of the surgical field
- BMI >35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The DySLOH Study: Dynamic Scaffold Versus Lichtenstein Open Hernioplasty. A Comparative Outcome Assessment Between the Two Techniques.
Evaluating the outcomes of patients undergoing open anterior inguinal hernioplasty comparing two different techniques: Lichtenstein/plug and mesh and ProFlor. The outcomes of these two groups of patients, respectively the Lichtenstein inguinal hernia repair with static flat mesh and the defect obliteration with 3D dynamic scaffold Proflor, are compared in respect to defined variables along stages: intraoperative, early and long term postoperative.
- Conditions
- Inguinal Hernia
- Being tested
- inguinal hernia repair with mesh
- Keywords
- inguinal hernia repair, ProFlor technique, lichtenstein hernia repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inguinal hernia repair with meshProcedure or surgery
inguinal hernia repair with mesh
| Study group | Role | What they receive |
|---|---|---|
| ProFlor | Experimental | patients underwent to inguinal hernia repair with use of ProFlor dynamic scaffold Receives: Procedure: inguinal hernia repair with mesh |
| Lichtenstein | Active comparator | patients underwent to Lichtenstein inguinal hernia repair Receives: Procedure: inguinal hernia repair with mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
early postoperative complications
bleeding, hematoma and infections
Measured: 30 days after surgery
patients clinical outcome
VAS score
Measured: 24 months
Secondary outcomes (1)
evaluation of quality of life during the postoperative period
Carolina Comfort Scale - CCS
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Antonino Agrusa, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706662
- Sponsor's protocol ID
- DySLOH
- Acronym
- DYSLOH
- Status last verified
- Jan 2023
- First submitted
- 21 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DySLOH Study: Dynamic Scaffold Versus Lichtenstein Open Hernioplasty. A Comparative Outcome Assessment Between the Two Techniques.
- ClinicalTrials.gov ID
- NCT05706662
- Acronym / sponsor ID
- DYSLOH / DySLOH
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia repair, ProFlor technique, lichtenstein hernia repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Jan 2023 (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.
Evaluating the outcomes of patients undergoing open anterior inguinal hernioplasty comparing two different techniques: Lichtenstein/plug and mesh and ProFlor. The outcomes of these two groups of patients, respectively the Lichtenstein inguinal hernia repair with static flat mesh and the defect obliteration with 3D dynamic scaffold Proflor, are compared in respect to defined variables along stages: intraoperative, early and long term postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProFlor | Experimental | Procedure: inguinal hernia repair with meshpatients underwent to inguinal hernia repair with use of ProFlor dynamic scaffold |
| Lichtenstein | Active comparator | Procedure: inguinal hernia repair with meshpatients underwent to Lichtenstein inguinal hernia repair |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients were individuals aged between 18 and 85 years old, competent to give consent, affected by clinically relevant primary inguinal hernia scheduled to undergo elective inguinal hernia repair and eligible for outpatient surgical procedure with local anesthesia.
Key exclusion criteria (13 listed)
- Recurrent inguinal hernia
- Incarcerated inguinal hernia
- Hernia not in the inguinal area
- Signs of obvious local or systemic infection
- ASA score > 4
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 |
|---|---|---|
| inguinal hernia repair with meshinguinal hernia repair with mesh | Procedure or surgery | Lichtenstein, ProFlor |
Primary outcome
early postoperative complications
Time frame: 30 days after surgery
bleeding, hematoma and infections
patients clinical outcome
Time frame: 24 months
VAS score
1 secondary outcome
evaluation of quality of life during the postoperative period
Time frame: 24 months
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 31 Jan 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inguinal hernia repair with mesh in people with Inguinal Hernia, run by University of Palermo at 1 site in Italy.
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 1 inclusion and 13 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 31 Jan 2023. 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 Italy. 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.
What does the primary outcome measure?
early postoperative complications (time frame: 30 days after surgery). The study lists 2 primary outcomes in all. 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 Jan 2023.