LaparoscopicNCT06258317
Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty
A study testing fixation of conventional polypropylene mesh in people with Laparoscopic and Inguinal Hernia, run by Assiut University.
Trial summary
Inguinal hernia is one of the most common types of abdominal hernias. Laparoscopic hernioplasty of inguinal hernia is a good alternative to traditional open repairs even in simple unilateral primary inguinal hernia in terms of decrease post operative pain and complications with comparable recurrence rates.Two… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic, Inguinal Hernia, Hernioplasty
- What is being tested?
- fixation of conventional polypropylene mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Mar 2027
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any male or female above 18 years old that has uncomplicated inguinal hernia
Who cannot join
- Patients with contraindications to use laparoscopy as cardiac or immunocompromised patients.
- Patients who are difficult to follow up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Inguinal hernia is one of the most common types of abdominal hernias. Laparoscopic hernioplasty of inguinal hernia is a good alternative to traditional open repairs even in simple unilateral primary inguinal hernia in terms of decrease post operative pain and complications with comparable recurrence rates.Two techniques are described in laparoscopic hernioplasty and have been extensively studied in randomised trials. The totally extraperitoneal (TEP) approach is more widely used than the transabdominal preperitoneal (TAPP) approach.
In this study we will compare between the results of mesh fixation and non fixation as regard operative and postoperative data.
- Conditions
- Laparoscopic, Inguinal Hernia, Hernioplasty
- Being tested
- fixation of conventional polypropylene mesh
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixation of conventional polypropylene meshProcedure or surgery
By fixation of the polyprolene mesh,patients will be divided into two groups:
Group 1 includes patients with fixation of conventional polypropylene mesh. Group 2 includes patients without fixation of the mesh.
| Study group | Role | What they receive |
|---|---|---|
| Mesh fixation | Experimental | Procedure/Surgery: fixation of conventional polypropylene mesh. This group includes patients with fixation of conventional polypropylene mesh. Receives: Procedure: fixation of conventional polypropylene mesh |
| Non-mesh fixation | Experimental | Procedure/Surgery: non-fixation of the mesh. This group includes patients without fixation of the mesh. Receives: Procedure: fixation of conventional polypropylene mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing fixation of conventional polypropylene mesh versus non fixation of 3D max mesh (anatomically oriented mesh) in laparoscopic trans-abdominal properitoneal (TAPP) inguinal hernia repair
Comparing fixation of conventional polypropylene mesh versus non fixation of 3D max mesh (anatomically oriented mesh) in laparoscopic transabdominal properitoneal (TAPP) inguinal hernia repair as regard operative and postoperative data.By following-up the patient while admitted post-operatively to check scrotal swelling by examination.After discharge contacting the patient 10 days, 20 days, one month, 2 months, 3 months, 6 months, one year, 2 years to check incidence of recurrence of hernia and return to normal life activities.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
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 LaparoscopicStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Makram George, Assiut University
- Investigators
- Mohamed A Rizk, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258317
- Sponsor's protocol ID
- inguinal hernioplasty
- Status last verified
- Feb 2024
- First submitted
- 22 Dec 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lockhart K, Dunn D, Teo S, Ng JY, Dhillon M, Teo E, van Driel ML. Mesh versus non-mesh for inguinal and femoral hernia repair. Cochrane Database Syst Rev. 2018 Sep 13;9(9):CD011517. doi: 10.1002/14651858.CD011517.pub2.
PubMed 30209805Sun P, Cheng X, Deng S, Hu Q, Sun Y, Zheng Q. Mesh fixation with glue versus suture for chronic pain and recurrence in Lichtenstein inguinal hernioplasty. Cochrane Database Syst Rev. 2017 Feb 7;2(2):CD010814. doi: 10.1002/14651858.CD010814.pub2.
PubMed 28170080
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty
- ClinicalTrials.gov ID
- NCT06258317
- Acronym / sponsor ID
- inguinal hernioplasty
- Conditions
- Laparoscopic, Inguinal Hernia, Hernioplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Feb 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.
Inguinal hernia is one of the most common types of abdominal hernias. Laparoscopic hernioplasty of inguinal hernia is a good alternative to traditional open repairs even in simple unilateral primary inguinal hernia in terms of decrease post operative pain and complications with comparable recurrence rates.Two techniques are described in laparoscopic hernioplasty and have been extensively studied in randomised trials. The totally extraperitoneal (TEP) approach is more widely used than the transabdominal preperitoneal (TAPP) approach.
In this study we will compare between the results of mesh fixation and non fixation as regard operative and postoperative data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh fixation | Experimental | Procedure: fixation of conventional polypropylene meshProcedure/Surgery: fixation of conventional polypropylene mesh. This group includes patients with fixation of conventional polypropylene mesh. |
| Non-mesh fixation | Experimental | Procedure: fixation of conventional polypropylene meshProcedure/Surgery: non-fixation of the mesh. This group includes patients without fixation of the mesh. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any male or female above 18 years old that has uncomplicated inguinal hernia
Key exclusion criteria (2 listed)
- Patients with contraindications to use laparoscopy as cardiac or immunocompromised patients.
- Patients who are difficult to follow up.
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 |
|---|---|---|
| fixation of conventional polypropylene meshBy fixation of the polyprolene mesh,patients will be divided into two groups: Group 1 includes patients with fixation of conventional polypropylene mesh. Group 2 includes patients without fixation of the mesh. | Procedure or surgery | Mesh fixation, Non-mesh fixation |
Primary outcome
Comparing fixation of conventional polypropylene mesh versus non fixation of 3D max mesh (anatomically oriented mesh) in laparoscopic trans-abdominal properitoneal (TAPP) inguinal hernia repair
Time frame: Baseline
Comparing fixation of conventional polypropylene mesh versus non fixation of 3D max mesh (anatomically oriented mesh) in laparoscopic transabdominal properitoneal (TAPP) inguinal hernia repair as regard operative and postoperative data.By following-up the patient while admitted post-operatively to check scrotal swelling by examination.After discharge contacting the patient 10 days, 20 days, one month, 2 months, 3 months, 6 months, one year, 2 years to check incidence of recurrence of hernia and return to normal life activities.
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 14 Feb 2024.
- Background: PubMed 30209805Lockhart K, Dunn D, Teo S, Ng JY, Dhillon M, Teo E, van Driel ML. Mesh versus non-mesh for inguinal and femoral hernia repair. Cochrane Database Syst Rev. 2018 Sep 13;9(9):CD011517. doi: 10.1002/14651858.CD011517.pub2.
- Background: PubMed 28170080Sun P, Cheng X, Deng S, Hu Q, Sun Y, Zheng Q. Mesh fixation with glue versus suture for chronic pain and recurrence in Lichtenstein inguinal hernioplasty. Cochrane Database Syst Rev. 2017 Feb 7;2(2):CD010814. doi: 10.1002/14651858.CD010814.pub2.
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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.
Mohamed A Rizk principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing fixation of conventional polypropylene mesh in people with Laparoscopic and Inguinal Hernia, run by Assiut 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 2 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: opening soon, as of the sponsor's last update on 14 Feb 2024. 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?
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 Mina M George (01021306788, minamakram1397@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing fixation of conventional polypropylene mesh versus non fixation of 3D max mesh (anatomically oriented mesh) in laparoscopic trans-abdominal properitoneal (TAPP) inguinal hernia repair (time frame: Baseline). 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 NCT06258317, 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 14 Feb 2024.