Incisional HerniaNCT05359510
The Use of Different Types of Mesh for Prevention of Incisional Hernia Versus Primary Abdominal Suturing
A study testing prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturing in people with Incisional Hernia, run by Assiut University at 1 site in Egypt.
Trial summary
The use of different types of mesh at different sites in prevention of incisional hernia after various abdominal incision versus primary abdominal suturing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Apr 2022to 1 Nov 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- patient age: ≥ 18 years
- patients undergoing elective or urgent open abdominal surgical procedure regardless of benign or malignant disease
Who cannot join
- age <18 years
- navel site infection
- pregnancy
- expected survival <12 month
- previous intra abdominal mesh placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Different Types of Mesh at Different Sites in the Prevention of Incisional Hernia After Various Abdominal Incision Versus Primary Abdominal Suturing.
The use of different types of mesh at different sites in prevention of incisional hernia after various abdominal incision versus primary abdominal suturing.
Read the detailed description
The burden of incisional hernia after abdominal exploration has raised the question if a prophylactic mesh placement during abdominal wall closure is of benefit.
The reported rate of incisional hernia after abdominal incisions varies from 4.2% up to a calculated risk of 73%. The impact on quality of life and annual health care costs has motivated various groups to research ways to decrease the rate of incisional hernia by optimizing the technique of abdominal wall closure.
One of the crucial risk factors of the genesis of incisional hernias is the malfunction of collagen synthesis. Other main risk factors are found to be obesity, steroid therapy, malnutrition, nicotine abuse, and other connective tissue diseases.
Since German physician Theodor Billroth's first suggested use of prosthetic material to close the hernia defect in 1890, continued interest lead to the development of a variety of surgical meshes and techniques for suture and mesh reinforcement to prevent incisional hernia . Overtime, RCTs have demonstrated the effectiveness of the use of prophylactic mesh in the prevention of incisional hernia. While surgeons world over use different techniques of positioning mesh in the prophylactic mesh repair (PMR) such as the Onlay, Sublay and Intraperitoneal positions, which can be associated with a high incidence of complications such as the postoperative seroma.
- Conditions
- Incisional Hernia
- Being tested
- prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturing
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturingProcedure or surgery
Also called closure of various abdominal incision by different types of prophylactic mesh at different sites for prevention of incisional hernia versus primary abdominal closure
before closure of the abdominal layers prophylactic mesh will be used for prevention of incisional hernia. another patient with abdominal incision , primary closure of abdominal layer will occur.
| Study group | Role | What they receive |
|---|---|---|
| patient with various abdominal incisions to be operated | Experimental | patients with various abdominal incisions for closure either by primary suturing or by mesh Receives: Procedure: prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
early wound complications
wound infection (with or without removal of the mesh) ,wound necrosis , wound hematoma
Measured: 1 month
late wound complications
post operative incisional hernia, wound infection (with or without removal of the mesh) wound necrosis wound hematoma.
Measured: 1 month
Secondary outcomes (2)
complication rate
major bleeding bowel injury
Measured: intraoperative complications will be recorded immediately after finishing the operation
incidence of incisional hernia
the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start26 Apr 2022
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolos Samer Shafik, Assiut University
- Investigators
- Mostafa Abdel Aziz, Study chair, general surgery Assiut universitiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359510
- Sponsor's protocol ID
- I H repair by mesh
- Status last verified
- Aug 2022
- First submitted
- 25 Apr 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: age ,sex ,clinical diagnosis
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Different Types of Mesh at Different Sites in the Prevention of Incisional Hernia After Various Abdominal Incision Versus Primary Abdominal Suturing.
- ClinicalTrials.gov ID
- NCT05359510
- Acronym / sponsor ID
- I H repair by mesh
- Conditions
- Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 4 May 2022 (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 use of different types of mesh at different sites in prevention of incisional hernia after various abdominal incision versus primary abdominal suturing.
Detailed description
The burden of incisional hernia after abdominal exploration has raised the question if a prophylactic mesh placement during abdominal wall closure is of benefit.
The reported rate of incisional hernia after abdominal incisions varies from 4.2% up to a calculated risk of 73%. The impact on quality of life and annual health care costs has motivated various groups to research ways to decrease the rate of incisional hernia by optimizing the technique of abdominal wall closure.
One of the crucial risk factors of the genesis of incisional hernias is the malfunction of collagen synthesis. Other main risk factors are found to be obesity, steroid therapy, malnutrition, nicotine abuse, and other connective tissue diseases.
Since German physician Theodor Billroth's first suggested use of prosthetic material to close the hernia defect in 1890, continued interest lead to the development of a variety of surgical meshes and techniques for suture and mesh reinforcement to prevent incisional hernia . Overtime, RCTs have demonstrated the effectiveness of the use of prophylactic mesh in the prevention of incisional hernia. While surgeons world over use different techniques of positioning mesh in the prophylactic mesh repair (PMR) such as the Onlay, Sublay and Intraperitoneal positions, which can be associated with a high incidence of complications such as the postoperative seroma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with various abdominal incisions to be operated | Experimental | Procedure: prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturingpatients with various abdominal incisions for closure either by primary suturing or by mesh |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- informed consent
- patient age: ≥ 18 years
- patients undergoing elective or urgent open abdominal surgical procedure regardless of benign or malignant disease
Key exclusion criteria (5 listed)
- age <18 years
- navel site infection
- pregnancy
- expected survival <12 month
- previous intra abdominal mesh placement
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 |
|---|---|---|
| prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturingAlso: closure of various abdominal incision by different types of prophylactic mesh at different sites for prevention of incisional hernia versus primary abdominal closurebefore closure of the abdominal layers prophylactic mesh will be used for prevention of incisional hernia. another patient with abdominal incision , primary closure of abdominal layer will occur. | Procedure or surgery | patient with various abdominal incisions to be operated |
Primary outcome
early wound complications
Time frame: 1 month
wound infection (with or without removal of the mesh) ,wound necrosis , wound hematoma
late wound complications
Time frame: 1 month
post operative incisional hernia, wound infection (with or without removal of the mesh) wound necrosis wound hematoma.
2 secondary outcomes
complication rate
Time frame: intraoperative complications will be recorded immediately after finishing the operation
incidence of incisional hernia
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: Yes. age ,sex ,clinical diagnosis
Related trials for Incisional Hernia
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Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
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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.
Mostafa Abdel Aziz study chair
general surgery Assiut universitiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturing in people with Incisional Hernia, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 5 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 26 Aug 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kerolos samer, Reside doctor (+201277838435, kerolos.samer1295@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early wound complications (time frame: 1 month). 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?
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 26 Aug 2022.