Inguinal HerniaNCT02329938
Desarda Repair for Inguinal Hernia
A study testing Lichtenstein tension free reair and Desarda's repair in people with Inguinal Hernia, run by Mansoura University.
Trial summary
Unlike Lichtenstein tension free repair for inguinal hernia, Desarda's repair was introduced as a pure tissue repair with no need for mesh. In other words; the complications which may arise from the use of a foreign body (mesh) will be avoided. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Lichtenstein tension free reair and Desarda's repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Dec 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inguinal hernia
Who cannot join
- recurrent inguinal hernia
- giant inguinal hernia
- mental disorder
- refusal to participate
About this study
Official title: Desarda Versus Lichtenstein's Repair for Inguinal Hernia: a Comparative Study
Unlike Lichtenstein tension free repair for inguinal hernia, Desarda's repair was introduced as a pure tissue repair with no need for mesh. In other words; the complications which may arise from the use of a foreign body (mesh) will be avoided. The idea was to evaluate the efficacy of this new repair and compare it to the standard Lichtenstein repair.
- Conditions
- Inguinal Hernia
- Being tested
- Lichtenstein tension free reair, Desarda's 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.
Lichtenstein tension free reairProcedure or surgery
Also called pure synthetic repair
a mesh is apllied on the posterior wall of the inguinal canal and sutured to the inguinal ligament below, to the internal oblique muscle above , and to rectus sheath medially.
Desarda's repairProcedure or surgery
Also called pure tissue reapir
the repair is done using a flap of the external oblique aponeurosis sutured to the inguinal ligament below and to the aponeurotic part of the internal oblique muscle above.
| Study group | Role | What they receive |
|---|---|---|
| Lichtenstein tension free reair | Active comparator | mesh repair of inguinal hernia Receives: Procedure: Lichtenstein tension free reair |
| Desarda's repair | Active comparator | non-mesh repair of inguinal hernia Receives: Procedure: Desarda's repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with recurrence of inguinal hernia
Measured: 2 years
Secondary outcomes (2)
VAS score for pain
Measured: one year
number of patients develped postoperative complications
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2014
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 Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Youssef Mohamed, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329938
- Sponsor's protocol ID
- MFM200956
- Status last verified
- Dec 2014
- First submitted
- 30 Dec 2014
- Last updated
- 1 Jan 2015
- Results posted
- No
Publications
Youssef T, El-Alfy K, Farid M. Randomized clinical trial of Desarda versus Lichtenstein repair for treatment of primary inguinal hernia. Int J Surg. 2015 Aug;20:28-34. doi: 10.1016/j.ijsu.2015.05.055. Epub 2015 Jun 11.
PubMed 26074293
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desarda Versus Lichtenstein's Repair for Inguinal Hernia: a Comparative Study
- ClinicalTrials.gov ID
- NCT02329938
- Acronym / sponsor ID
- MFM200956
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Jan 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.
Unlike Lichtenstein tension free repair for inguinal hernia, Desarda's repair was introduced as a pure tissue repair with no need for mesh. In other words; the complications which may arise from the use of a foreign body (mesh) will be avoided. The idea was to evaluate the efficacy of this new repair and compare it to the standard Lichtenstein repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lichtenstein tension free reair | Active comparator | Procedure: Lichtenstein tension free reairmesh repair of inguinal hernia |
| Desarda's repair | Active comparator | Procedure: Desarda's repairnon-mesh repair of inguinal hernia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- inguinal hernia
Key exclusion criteria (4 listed)
- recurrent inguinal hernia
- giant inguinal hernia
- mental disorder
- refusal to participate
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 |
|---|---|---|
| Lichtenstein tension free reairAlso: pure synthetic repaira mesh is apllied on the posterior wall of the inguinal canal and sutured to the inguinal ligament below, to the internal oblique muscle above , and to rectus sheath medially. | Procedure or surgery | Lichtenstein tension free reair |
| Desarda's repairAlso: pure tissue reapirthe repair is done using a flap of the external oblique aponeurosis sutured to the inguinal ligament below and to the aponeurotic part of the internal oblique muscle above. | Procedure or surgery | Desarda's repair |
Primary outcome
number of patients with recurrence of inguinal hernia
Time frame: 2 years
2 secondary outcomes
VAS score for pain
Time frame: one year
number of patients develped postoperative complications
Time frame: 2 years
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 1 Jan 2015.
- Derived from this study: PubMed 26074293Youssef T, El-Alfy K, Farid M. Randomized clinical trial of Desarda versus Lichtenstein repair for treatment of primary inguinal hernia. Int J Surg. 2015 Aug;20:28-34. doi: 10.1016/j.ijsu.2015.05.055. Epub 2015 Jun 11.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Lichtenstein tension free reair and Desarda's repair in people with Inguinal Hernia, run by Mansoura University.
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 4 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 1 Jan 2015. 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. 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?
number of patients with recurrence of inguinal hernia (time frame: 2 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 NCT02329938, 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 1 Jan 2015.