Incisional HerniaNCT06178965
Incisional Hernia Repair by Abdominal Wall Component Release With Contemporary Onlay Mesh Fixation
A study testing Incisional Hernia Repair by Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation in people with Incisional Hernia and Onlay Mesh, run by Zagazig University at 1 site in Egypt.
Trial summary
There is a great expansion in the presentation of complex incisional hernia defects. Primary closure for most cases is impossible with a high rate of recurrence. Component separation provides an autologous repair of the defect but still has considerable recurrence rate. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia, Onlay Mesh, Abdominal Wall Component Release
- What is being tested?
- Incisional Hernia Repair by Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 Jun 2024
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age of 16 years and older.
- Both sexes.
- Patients with clean incisional hernia of stage I, II and III according to the ventral hernia staging system were included.
Who cannot join
- - Obese patients with BMI ≥35 kg/m2, Patients with contaminated hernia stage II and III, patients with collagen disease, patients with history of aortobifemoral bypass, Patients refusing mesh hernioplasty, Females in childbearing age who looks for further children, Patients unfit for surgery according to ASA criteria, Patients with a parastomal hernia, patient with a stoma and patients with uncontrolled diabetics, active smokers, and patients with COPD were excluded
Trial locations and contacts
1 site in 1 country.
About this study
There is a great expansion in the presentation of complex incisional hernia defects. Primary closure for most cases is impossible with a high rate of recurrence. Component separation provides an autologous repair of the defect but still has considerable recurrence rate. Reinforcement of component separation provides a more strength full repair and may be less recurrence.
Read the detailed description
the surgical correction was done under general anesthesia. After scrubbing and draping, an elliptical incision was performed .
Open the hernia sac then reduce the contents with adhesolysis as required. subcutaneous flaps on both sides were created in a manner that permit to spread an 8 cm mesh after the closure of the abdominal wall. approximate the facia after trimming of its edges with clamps with a manner that allow 1to 2 cm overlap in the midline without tension.
In case of tension do selective myofascial advancement (sequential components release). Our steps would be first a unilateral posterior rectus sheath release (1-2 cm longuitodinal incision lateral to linea alba) and reassess, if tension still present, bilateral posterior sheath release should be performed.If tension still present, do a unilateral then bilateral external oblique release as required (1-2 cm lateral to the linea semilunaris along the length of the abdominal wall).
close the defect with prolene 1 then cover with onlay wide pore mesh fixation with 2/0 prolene. Close the skin after placement of 2 subcutaneous suction drains.
- Being tested
- Incisional Hernia Repair by Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisional Hernia Repair by Abdominal Wall Component Release with Contemporary Onlay Mesh FixationProcedure or surgery
patients with incisional hernia will be operated by hernia reduction and sac closure followed by placement of onlay mesh after creating suitable flaps.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation | Other | Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation in patients with incisional hernia Receives: Procedure: Incisional Hernia Repair by Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
detect black color at the incision site
the detection by vision
Measured: postoperative day 1 and 2
Secondary outcomes (1)
detect pulge at incision site
detect by vision
Measured: from postoperative day 1 to 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Dec 2022
- Primary completion1 Dec 2023
- Study completion1 Jun 2024 (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 Zagazig 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yasser Ali Orban, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178965
- Sponsor's protocol ID
- incisional hernia repair
- Status last verified
- Dec 2023
- First submitted
- 16 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisional Hernia Repair by Abdominal Wall Component Release With Contemporary Onlay Mesh Fixation
- ClinicalTrials.gov ID
- NCT06178965
- Acronym / sponsor ID
- incisional hernia repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 21 Dec 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.
There is a great expansion in the presentation of complex incisional hernia defects. Primary closure for most cases is impossible with a high rate of recurrence. Component separation provides an autologous repair of the defect but still has considerable recurrence rate. Reinforcement of component separation provides a more strength full repair and may be less recurrence.
Detailed description
the surgical correction was done under general anesthesia. After scrubbing and draping, an elliptical incision was performed .
Open the hernia sac then reduce the contents with adhesolysis as required. subcutaneous flaps on both sides were created in a manner that permit to spread an 8 cm mesh after the closure of the abdominal wall. approximate the facia after trimming of its edges with clamps with a manner that allow 1to 2 cm overlap in the midline without tension.
In case of tension do selective myofascial advancement (sequential components release). Our steps would be first a unilateral posterior rectus sheath release (1-2 cm longuitodinal incision lateral to linea alba) and reassess, if tension still present, bilateral posterior sheath release should be performed.If tension still present, do a unilateral then bilateral external oblique release as required (1-2 cm lateral to the linea semilunaris along the length of the abdominal wall).
close the defect with prolene 1 then cover with onlay wide pore mesh fixation with 2/0 prolene. Close the skin after placement of 2 subcutaneous suction drains.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation | Other | Procedure: Incisional Hernia Repair by Abdominal Wall Component Release with Contemporary Onlay Mesh FixationAbdominal Wall Component Release with Contemporary Onlay Mesh Fixation in patients with incisional hernia |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 16 years and older.
- Both sexes.
- Patients with clean incisional hernia of stage I, II and III according to the ventral hernia staging system were included.
Key exclusion criteria (1 listed)
- - Obese patients with BMI ≥35 kg/m2, Patients with contaminated hernia stage II and III, patients with collagen disease, patients with history of aortobifemoral bypass, Patients refusing mesh hernioplasty, Females in childbearing age who looks for further children, Patients unfit for surgery according to ASA criteria, Patients with a parastomal hernia, patient with a stoma and patients with uncontrolled diabetics, active smokers, and patients with COPD were excluded
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 |
|---|---|---|
| Incisional Hernia Repair by Abdominal Wall Component Release with Contemporary Onlay Mesh Fixationpatients with incisional hernia will be operated by hernia reduction and sac closure followed by placement of onlay mesh after creating suitable flaps. | Procedure or surgery | Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation |
Primary outcome
detect black color at the incision site
Time frame: postoperative day 1 and 2
the detection by vision
1 secondary outcome
detect pulge at incision site
Time frame: from postoperative day 1 to 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incisional Hernia Repair by Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation in people with Incisional Hernia and Onlay Mesh, run by Zagazig 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 1 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 21 Dec 2023. 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?
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?
detect black color at the incision site (time frame: postoperative day 1 and 2). 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 21 Dec 2023.