Hernia, InguinalDESLICHNCT01237470
The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment.
A study testing Desarda technique and Lichtenstein technique in people with Hernia, Inguinal, run by Nicolaus Copernicus University at 1 site in Poland.
Trial summary
Contemporary treatment of inguinal hernia is generally based on surgical methods with the use of synthetic meshes. The implanted meshes however have some disadvantages: they increase the risk of infection, tend to sustain inflammation process, can generate chronic pain and fertility disorders, can move from the… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Desarda technique and Lichtenstein technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,009 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2005to Jun 2009
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary inguinal hernia
- male adults
- signed informed consent
- god condition of external oblique aponeurosis (assessed during the operation)
Who cannot join
- age < 18
- recurrent hernia
- incarcerated hernia
- diagnosed mental disorder
- manual reduction of hernia on inpatient
- infection at groin area
- wound or scar at the groin
- no consent
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University
Bydgoszcz, 85-094
About this study
Official title: The Desarda and Lichtenstein Techniques in Primary Hernia Treatment in Adult Males: Randomised, Multicenter, Blinded Study.
Contemporary treatment of inguinal hernia is generally based on surgical methods with the use of synthetic meshes. The implanted meshes however have some disadvantages: they increase the risk of infection, tend to sustain inflammation process, can generate chronic pain and fertility disorders, can move from the initial implantation site, increase costs of treatment etc. The research to find any new hernioplasty without the use of meshes is still going on.
Desarda in 2002 year published his own results over hernia treatment with the use of external oblique aponeurosis. These results were comparable with the effects of Lichtenstein technique.
Read more
The initial assessment done in our own department revealed good clinical results after hernia treatment with Desarda's method.
To make appropriate and objective clinical assessment of the Desarda's technique for primary inguinal hernia treatment the randomized multicentre double blinded clinical trial (RCT) was projected and conducted. Finally, 105 patients were included in the Desarda group and 103 in the Lichtenstein group. Personal clinical follow up was made up to 3 years after operation.
Generally no statistically significant differences were found between these groups. The only difference was higher rate of seroma after Lichtenstein technique and different pain perception in both groups. To the summary it is clear that Desarda technique is quite attractive and good proposition for operative hernia treatment without mesh. The RCT was done with the use of SharePoint Portal Server (Microsoft) which seems to be appropriate for clinical trials.
- Conditions
- Hernia, Inguinal
- Being tested
- Desarda technique, Lichtenstein technique
- Keywords
- inguinal hernia, hernia recurrence, no mesh techniques, 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.
Desarda techniqueProcedure or surgery
no mesh technique with undetached strip of external oblique aponeurosis placed at the floor of inguinal canal
Lichtenstein techniqueProcedure or surgery
Also called open plain mesh technique
hernioplasty with the usage of plain polypropylene mesh
| Study group | Role | What they receive |
|---|---|---|
| Desarda group | Experimental | Patients with primary inguinal hernia operated using the Desarda technique Receives: Procedure: Desarda technique |
| Lichtenstein group | Experimental | Patients with primary inguinal hernia operated using the Lichtenstein technique. Receives: Procedure: Lichtenstein technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
hernia recurrence after surgical treatement
Measured: 3 years
chronic pain
persistent chronic pain (lasting longer then 6 months)
Measured: 6 months
Secondary outcomes (1)
surgical complications
edema, hematoma, ecchymosis, infaction of the wound
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startJan 2005
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: protocol completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,009 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Investigators
- Stanislaw Dabrowiecki, MD, PhD, Study chair, Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University Bydgoszcz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237470
- Sponsor's protocol ID
- Nicolaus Copernicus University
- Acronym
- DESLICH
- Status last verified
- Jul 2010
- First submitted
- 8 Nov 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Desarda MP. Inguinal herniorrhaphy with an undetached strip of external oblique aponeurosis: a new approach used in 400 patients. Eur J Surg. 2001 Jun;167(6):443-8. doi: 10.1080/110241501750243798.
PubMed 11471669Desarda MP. Surgical physiology of inguinal hernia repair--a study of 200 cases. BMC Surg. 2003 Apr 16;3:2. doi: 10.1186/1471-2482-3-2.
PubMed 12697071
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Desarda and Lichtenstein Techniques in Primary Hernia Treatment in Adult Males: Randomised, Multicenter, Blinded Study.
- ClinicalTrials.gov ID
- NCT01237470
- Acronym / sponsor ID
- DESLICH / Nicolaus Copernicus University
- Conditions
- Hernia, Inguinal
- Keywords
- inguinal hernia, hernia recurrence, no mesh techniques, Desarda technique
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: protocol completed
- Enrolment
- 2,009 participants (actual)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Nov 2010 (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.
Contemporary treatment of inguinal hernia is generally based on surgical methods with the use of synthetic meshes. The implanted meshes however have some disadvantages: they increase the risk of infection, tend to sustain inflammation process, can generate chronic pain and fertility disorders, can move from the initial implantation site, increase costs of treatment etc. The research to find any new hernioplasty without the use of meshes is still going on.
Desarda in 2002 year published his own results over hernia treatment with the use of external oblique aponeurosis. These results were comparable with the effects of Lichtenstein technique.
The initial assessment done in our own department revealed good clinical results after hernia treatment with Desarda's method.
To make appropriate and objective clinical assessment of the Desarda's technique for primary inguinal hernia treatment the randomized multicentre double blinded clinical trial (RCT) was projected and conducted. Finally, 105 patients were included in the Desarda group and 103 in the Lichtenstein group. Personal clinical follow up was made up to 3 years after operation.
Generally no statistically significant differences were found between these groups. The only difference was higher rate of seroma after Lichtenstein technique and different pain perception in both groups. To the summary it is clear that Desarda technique is quite attractive and good proposition for operative hernia treatment without mesh. The RCT was done with the use of SharePoint Portal Server (Microsoft) which seems to be appropriate for clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desarda group | Experimental | Procedure: Desarda techniquePatients with primary inguinal hernia operated using the Desarda technique |
| Lichtenstein group | Experimental | Procedure: Lichtenstein techniquePatients with primary inguinal hernia operated using the Lichtenstein technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary inguinal hernia
- male adults
- signed informed consent
- god condition of external oblique aponeurosis (assessed during the operation)
Key exclusion criteria (8 listed)
- age < 18
- recurrent hernia
- incarcerated hernia
- diagnosed mental disorder
- manual reduction of hernia on inpatient
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 |
|---|---|---|
| Desarda techniqueno mesh technique with undetached strip of external oblique aponeurosis placed at the floor of inguinal canal | Procedure or surgery | Desarda group |
| Lichtenstein techniqueAlso: open plain mesh techniquehernioplasty with the usage of plain polypropylene mesh | Procedure or surgery | Lichtenstein group |
Primary outcome
recurrence
Time frame: 3 years
hernia recurrence after surgical treatement
chronic pain
Time frame: 6 months
persistent chronic pain (lasting longer then 6 months)
1 secondary outcome
surgical complications
Time frame: 3 years
Results and safety
The study was stopped early (reason given: protocol completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
- Background: PubMed 11471669Desarda MP. Inguinal herniorrhaphy with an undetached strip of external oblique aponeurosis: a new approach used in 400 patients. Eur J Surg. 2001 Jun;167(6):443-8. doi: 10.1080/110241501750243798.
- Background: PubMed 12697071Desarda MP. Surgical physiology of inguinal hernia repair--a study of 200 cases. BMC Surg. 2003 Apr 16;3:2. doi: 10.1186/1471-2482-3-2.
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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.
Stanislaw Dabrowiecki, MD, PhD study chair
Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University Bydgoszcz, Poland
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 technique and Lichtenstein technique in people with Hernia, Inguinal, run by Nicolaus Copernicus University at 1 site in Poland.
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 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: stopped early, as of the sponsor's last update on 9 Nov 2010. 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 Poland. 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 was stopped early (reason given: protocol completed). 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?
recurrence (time frame: 3 years). 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?
On the ClinicalTrials.gov record for NCT01237470, which also lists 2 linked publications.
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 9 Nov 2010.