Incidence of Mesh Infection In HernioplastyNCT05775276
Incidence Of Mesh Infection After Hernioplasty In Obstructed and Strangulated Hernia Using Proline Mesh and Sutures
A study testing Proline mesh in hernioplasty in people with Incidence of Mesh Infection In Hernioplasty, run by Assiut University.
Trial summary
The primary aim of this study is to detect incidence of mesh infection in cases presented with obstructed or strandulated hernia.A prospective controlled study will be carried out after obtaining written informed consent from all patients and approval of the ethics committee of the faculty of medicine, Assuit… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Incidence of Mesh Infection In Hernioplasty
- What is being tested?
- Proline mesh in hernioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Feb 2025
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients aging above 21 years old, who presented with obstructed or strangulated hernia with viable bowel loops by clinical examination or detected by preoperative ultrasound or computed tomography CT imaging.
Who cannot join
- Uncomplicated hernia.
- patients who will underwent rescection and anastmosis
- patient cannot withstand anethesia.
- Decompensated liver patients.
- Pregnancy.
- Immunosuppressed patients e.g.: under chemotherapy or steroids.
Trial locations and contacts
No sites are listed yet.
About this study
The primary aim of this study is to detect incidence of mesh infection in cases presented with obstructed or strandulated hernia.A prospective controlled study will be carried out after obtaining written informed consent from all patients and approval of the ethics committee of the faculty of medicine, Assuit University.
Read the detailed description
There is controversy regarding the use of prolene mesh in cases of obstructed and strangulated hernia. The main aim and objective of this prospective study is to evaluate the outcomes and incidence of mesh infection in hernioplasty in emergency situations like obstructed and strangulated hernia .Hernioplasty is the most common surgery for hernia repair with Propylene mesh,but the use of synthetic prosthesis is associated with increase risk of developing a prosthetic infection that may manifest after time as subtle symptoms in the form of fever, myalgia, erythema of overlying skin and in some cases as chronic discharging sinus(1). clinicians have been challenged in the past few years by an increasing variety of novel non-infectious and infectious complications following the widespread use of meshes after open repair of hernias this incidence is influenced by underlying co-morbidities, the type of mesh, the surgical technique and the strategy used to prevent infections. An approach that combines medical and surgical management is necessary for cases of mesh infection.(2)
- Being tested
- Proline mesh in hernioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proline mesh in hernioplastyProcedure or surgery
Hernioplasty using proline mesh then follow up for incidence of infection
| Study group | Role | What they receive |
|---|---|---|
| Incidence Of Mesh Infection After proline mesh Hernioplasty | Experimental | Cases presented with strangulated or obstructed hernia Receives: Procedure: Proline mesh in hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Of Mesh Infection After Hernioplasty In Complicated Hernia Using Proline Mesh and Sutures
To evaluate the incidence of mesh infection in Complicated hernia using prolene mesh and sutures,along postoperative hospital stay, routine follow up and time to return to activities of daily living.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (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 Incidence of Mesh Infection In HernioplastyStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All adult patients aging above 21 years old, who presented with obstructed or strangulated hernia with viable bowel loops by clinical examination or detected by preoperative ultrasound or computed tomography CT imaging.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ashraf Abdelnaeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775276
- Sponsor's protocol ID
- Incidence Of Mesh Infection
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chung L, Tse GH, O'Dwyer PJ. Outcome of patients with chronic mesh infection following abdominal wall hernia repair. Hernia. 2014 Oct;18(5):701-4. doi: 10.1007/s10029-014-1277-x. Epub 2014 Jul 20.
PubMed 25038894Sanchez VM, Abi-Haidar YE, Itani KM. Mesh infection in ventral incisional hernia repair: incidence, contributing factors, and treatment. Surg Infect (Larchmt). 2011 Jun;12(3):205-10. doi: 10.1089/sur.2011.033. Epub 2011 Jul 18.
PubMed 21767146
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence Of Mesh Infection After Hernioplasty In Obstructed and Strangulated Hernia Using Proline Mesh and Sutures
- ClinicalTrials.gov ID
- NCT05775276
- Acronym / sponsor ID
- Incidence Of Mesh Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 20 Mar 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.
The primary aim of this study is to detect incidence of mesh infection in cases presented with obstructed or strandulated hernia.A prospective controlled study will be carried out after obtaining written informed consent from all patients and approval of the ethics committee of the faculty of medicine, Assuit University.
Detailed description
There is controversy regarding the use of prolene mesh in cases of obstructed and strangulated hernia. The main aim and objective of this prospective study is to evaluate the outcomes and incidence of mesh infection in hernioplasty in emergency situations like obstructed and strangulated hernia .Hernioplasty is the most common surgery for hernia repair with Propylene mesh,but the use of synthetic prosthesis is associated with increase risk of developing a prosthetic infection that may manifest after time as subtle symptoms in the form of fever, myalgia, erythema of overlying skin and in some cases as chronic discharging sinus(1). clinicians have been challenged in the past few years by an increasing variety of novel non-infectious and infectious complications following the widespread use of meshes after open repair of hernias this incidence is influenced by underlying co-morbidities, the type of mesh, the surgical technique and the strategy used to prevent infections. An approach that combines medical and surgical management is necessary for cases of mesh infection.(2)
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All adult patients aging above 21 years old, who presented with obstructed or strangulated hernia with viable bowel loops by clinical examination or detected by preoperative ultrasound or computed tomography CT imaging.
| Arm | Type | Receives |
|---|---|---|
| Incidence Of Mesh Infection After proline mesh Hernioplasty | Experimental | Procedure: Proline mesh in hernioplastyCases presented with strangulated or obstructed hernia |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients aging above 21 years old, who presented with obstructed or strangulated hernia with viable bowel loops by clinical examination or detected by preoperative ultrasound or computed tomography CT imaging.
Key exclusion criteria (6 listed)
- Uncomplicated hernia.
- patients who will underwent rescection and anastmosis
- patient cannot withstand anethesia.
- Decompensated liver patients.
- Pregnancy.
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 |
|---|---|---|
| Proline mesh in hernioplastyHernioplasty using proline mesh then follow up for incidence of infection | Procedure or surgery | Incidence Of Mesh Infection After proline mesh Hernioplasty |
Primary outcome
Incidence Of Mesh Infection After Hernioplasty In Complicated Hernia Using Proline Mesh and Sutures
Time frame: Baseline
To evaluate the incidence of mesh infection in Complicated hernia using prolene mesh and sutures,along postoperative hospital stay, routine follow up and time to return to activities of daily living.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Results publication: PubMed 25038894Chung L, Tse GH, O'Dwyer PJ. Outcome of patients with chronic mesh infection following abdominal wall hernia repair. Hernia. 2014 Oct;18(5):701-4. doi: 10.1007/s10029-014-1277-x. Epub 2014 Jul 20.
- Results publication: PubMed 21767146Sanchez VM, Abi-Haidar YE, Itani KM. Mesh infection in ventral incisional hernia repair: incidence, contributing factors, and treatment. Surg Infect (Larchmt). 2011 Jun;12(3):205-10. doi: 10.1089/sur.2011.033. Epub 2011 Jul 18.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Proline mesh in hernioplasty in people with Incidence of Mesh Infection In Hernioplasty, 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 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: status not confirmed, as of the sponsor's last update on 20 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Sayed (01060164660, Mohamedashraf016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Of Mesh Infection After Hernioplasty In Complicated Hernia Using Proline Mesh and Sutures (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 NCT05775276, 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 20 Mar 2023.