Inguinal Hernia UnilateralHP-tisNCT06650878
Desarda Tissue Technique vs Lichtenstein Technique for Primary Inguinal Hernia Repair
A study testing Desarda and Lichtenstein in people with Inguinal Hernia Unilateral and Complications of Surgical Procedures or Medical Care, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial summary
This study aims to evaluate whether a surgical technique (Desarda) is superior to the commonly used surgical technique (Lichtenstein) in inguinal hernia repair concerning the occurrence of postoperative complications. The Lichtenstein technique involves the use of a mesh, while the Desarda technique does not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia Unilateral, Complications of Surgical Procedures or Medical Care
- What is being tested?
- Desarda and Lichtenstein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 1 siteSpain
- Study dates
- 26 Mar 2025to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosed with primary inguinal hernia.
- Body mass index below 31
- Indication for inguinal hernia repair via anterior approach, either as outpatient surgery (CMA) or elective admission.
- Legal capacity to provide informed consent.
Who cannot join
- Patients with a weak, thin, or divided external oblique aponeurosis.
- Participants diagnosed with any of the following conditions:
- Ongoing oncological disease
- Cirrhotic patients classified as Child B or higher
- Women who have previously undergone a cesarean section
- Cognitive or affective conditions that limit the ability to cooperate with the study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
CSAPG
Sant Pere de Ribes, Barcelona, 08810
Javier Errando, MD, +34 938960025, jerrando@csapg.cat
Noemi Casaponsa, recerca@csapg.cat, +34 938960025 ext. 43197, recerca@csapg.cat
About this study
Official title: Randomized Controlled Trial Comparing the Desarda Tissue Technique With the Lichtenstein Technique in Primary Inguinal Hernia Repair
This study aims to evaluate whether a surgical technique (Desarda) is superior to the commonly used surgical technique (Lichtenstein) in inguinal hernia repair concerning the occurrence of postoperative complications. The Lichtenstein technique involves the use of a mesh, while the Desarda technique does not.
- Being tested
- Desarda, Lichtenstein
- Keywords
- Inguinal Hernia, lichtenstein technique, desarda technique
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesardaProcedure or surgery
This technique prevent from using a mesh to surgical repair of a inguinal hernia
LichtensteinProcedure or surgery
This technique implies using a mesh to surgical repair of a inguinal hernia
| Study group | Role | What they receive |
|---|---|---|
| Desarda Technique | Experimental | Patients asigned to this arm will be treated with Desarda Technique Receives: Procedure: Desarda |
| Lichtenstein Technique | Active comparator | Patients asigned to this arm will be treated with Lichtenstein Technique Receives: Procedure: Lichtenstein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Participants with Post-surgery Complications
Any of the following complications: ● Sensation of a foreign body that persists beyond 3 months after surgery, self-reported by the participant ● Seroma within the first 30 days after surgery, verified through physical examination by a surgeon ● Hematoma within the first 30 days after surgery, verified through physical examination by a surgeon ● Infection at the surgical site within the first 30 days after surgery, verified by a surgeon ● Severe postoperative pain (7 or higher on the visual analog scale [VAS]) within the first 30 days after surgery, self-reported by the participant ● Chronic postoperative pain (persisting more than three months after surgery), self-reported by the participant ● Persistent loss of skin sensitivity beyond 30 days after surgery, self-reported by the participant ● Limitation of normal activities at home, outside the home, or at work beyond 3 months after surgery, self-reported by the participant
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start26 Mar 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia UnilateralStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 478 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Errando, MD, Principal investigator, CSAPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650878
- Sponsor's protocol ID
- CSAPG-65
- Acronym
- HP-tis
- Status last verified
- Jun 2025
- First submitted
- 18 Oct 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Desarda Tissue Technique With the Lichtenstein Technique in Primary Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT06650878
- Acronym / sponsor ID
- HP-tis / CSAPG-65
- Keywords
- Inguinal Hernia, lichtenstein technique, desarda technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 478 participants (estimated)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 21 Oct 2024 (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.
This study aims to evaluate whether a surgical technique (Desarda) is superior to the commonly used surgical technique (Lichtenstein) in inguinal hernia repair concerning the occurrence of postoperative complications. The Lichtenstein technique involves the use of a mesh, while the Desarda technique does not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desarda Technique | Experimental | Procedure: DesardaPatients asigned to this arm will be treated with Desarda Technique |
| Lichtenstein Technique | Active comparator | Procedure: LichtensteinPatients asigned to this arm will be treated with Lichtenstein Technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with primary inguinal hernia.
- Body mass index below 31
- Indication for inguinal hernia repair via anterior approach, either as outpatient surgery (CMA) or elective admission.
- Legal capacity to provide informed consent.
Key exclusion criteria (6 listed)
- Patients with a weak, thin, or divided external oblique aponeurosis.
- Participants diagnosed with any of the following conditions:
- Women who have previously undergone a cesarean section
- Cognitive or affective conditions that limit the ability to cooperate with the study procedures
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 |
|---|---|---|
| DesardaThis technique prevent from using a mesh to surgical repair of a inguinal hernia | Procedure or surgery | Desarda Technique |
| LichtensteinThis technique implies using a mesh to surgical repair of a inguinal hernia | Procedure or surgery | Lichtenstein Technique |
Primary outcome
Rate of Participants with Post-surgery Complications
Time frame: 3 months
Any of the following complications: ● Sensation of a foreign body that persists beyond 3 months after surgery, self-reported by the participant ● Seroma within the first 30 days after surgery, verified through physical examination by a surgeon ● Hematoma within the first 30 days after surgery, verified through physical examination by a surgeon ● Infection at the surgical site within the first 30 days after surgery, verified by a surgeon ● Severe postoperative pain (7 or higher on the visual analog scale [VAS]) within the first 30 days after surgery, self-reported by the participant ● Chronic postoperative pain (persisting more than three months after surgery), self-reported by the participant ● Persistent loss of skin sensitivity beyond 30 days after surgery, self-reported by the participant ● Limitation of normal activities at home, outside the home, or at work beyond 3 months after surgery, self-reported by the participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: Yes. IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
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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.
Javier Errando, MD principal investigator
CSAPG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desarda and Lichtenstein in people with Inguinal Hernia Unilateral and Complications of Surgical Procedures or Medical Care, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier Errando, MD (+34938960025, jerrando@csapg.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Participants with Post-surgery Complications (time frame: 3 months). 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 24 Jun 2025.