Ventral HerniaNCT06643234
Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias
A study testing Ventral hernia repair in people with Ventral Hernia, run by Ahmed Kahlawy Mahrous Mohamed.
Trial summary
The aims of this study is to compare the efficacy of modified sublay hernioplasty versus intraperitoneal onlay mesh repair for large ventral hernias. Specifically, this study will assess the primary outcome of recurrence rate one year post surgery and evaluate secondary outcomes, including intraoperative… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Ventral hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Dec 2026
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age (18-70) years, both sexes.
- Fitness for surgery.
- Patients with uncomplicated ventral hernia.
- Large anterior abdominal wall defect.
Who cannot join
- Patients don't fit for general anesthesia due to sever co-morbidity.
- Patients with complicated ventral hernia.
- Patient refusal of surgical intervention.
- History of bleeding disorders.
- Pregnancy in female patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ahmed M Abdallah, Doctor contact
About this study
Official title: Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias. A New Technique
The aims of this study is to compare the efficacy of modified sublay hernioplasty versus intraperitoneal onlay mesh repair for large ventral hernias.
Specifically, this study will assess the primary outcome of recurrence rate one year post surgery and evaluate secondary outcomes, including intraoperative complications, infection rates, pain levels, and post operative hospital stay durations.
Read the detailed description
In general surgery, the management of ventral abdominal hernias characterized by the protrusion of tissue through weaknesses in the abdominal wall presents significant challenges, particularly when dealing with large ventral hernias, defined as those ≥10 cm or those under tension if closed primarily.
Incisional hernias, a specific subset of ventral hernias, add to the complexity of repair.
While the Intraperitoneal Onlay Mesh (IPOM) technique is noted for its reduced surgical and postoperative complications and lower reoperation rates, it also suffers from high costs, limited availability of specialized meshes like dynamesh, and increased intraoperative complications.
Alternatively, the modified open sublay technique, which employs a primary retro-muscular fascial repair and uses an affordable polypropylene mesh, offers a promising and cost effective solution with potential for a tension free repair.
This thesis aims to evaluate and compare these techniques to identify the most effective approach for large ventral hernia repair, balancing surgical outcomes, and complication rates.
- Conditions
- Ventral Hernia
- Being tested
- Ventral hernia repair
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventral hernia repairProcedure or surgery
Comparative between both techniques
| Study group | Role | What they receive |
|---|---|---|
| Group (A) modified sublay hernioplasty: | Active comparator | In the classic sublay hernioplasty technique, the hernia sac remains unopened. The procedure involves dissection of the posterior rectus sheath, which is then sutured at the midline. A mesh is placed behind the rectus muscle and in front of the posterior rectus sheath. Subsequently, the rectus muscle and anterior rectus sheath are sutured together at the midline, introducing tension to the repair. Conversely, the modified sublay hernioplasty technique follows a similar approach but with a key difference: the rectus muscle and anterior rectus sheath are left undisturbed without suturing them together. This modification aims to achieve a tension free repair, potentially reducing complications and enhancing overall outcomes. Receives: Procedure: Ventral hernia repair |
| Group (B) IPOM: | Active comparator | The hernia repair procedure involved several key steps. First, the hernial sac was fully exposed and completely removed. Following this, a synthetic mesh was placed internally, covering the defect with overlapping edges to ensure adequate reinforcement. The mesh was then fixed to the anterior abdominal wall using sutures, which were applied through the supporting layers of the abdominal wall to secure the mesh in place. Preoperatively, all patients underwent comprehensive general and local examinations, routine laboratory blood tests, and abdominal ultrasound to evaluate the size of the hernia defect. Receives: Procedure: Ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Recurrence rate one year post operative.
Number of recurrent cases
Measured: 1 year postoperative
Secondary outcomes (1)
1-infection rates(number of cases) 2-pain level( according to Visual Analog Score for pain) 3-post operative hospital stay duration(number of days) 4-intra and post operative complications(as iatrogenic injury and adhesions).
The number of cases come with post operative infection , pain(according to pain rating scale) , postoperative days of stay and intraoperative complications.
Measured: 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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 Ventral HerniaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Prospective randomized controlled study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Kahlawy Mahrous Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Kahlawy Mahrous Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643234
- Sponsor's protocol ID
- Large abdominal hernia
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kockerling F, Simon T, Adolf D, Kockerling D, Mayer F, Reinpold W, Weyhe D, Bittner R. Laparoscopic IPOM versus open sublay technique for elective incisional hernia repair: a registry-based, propensity score-matched comparison of 9907 patients. Surg Endosc. 2019 Oct;33(10):3361-3369. doi: 10.1007/s00464-018-06629-2. Epub 2019 Jan 2.
PubMed 30604264
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias. A New Technique
- ClinicalTrials.gov ID
- NCT06643234
- Acronym / sponsor ID
- Large abdominal hernia
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ahmed Kahlawy Mahrous MohamedUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Oct 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.
The aims of this study is to compare the efficacy of modified sublay hernioplasty versus intraperitoneal onlay mesh repair for large ventral hernias.
Specifically, this study will assess the primary outcome of recurrence rate one year post surgery and evaluate secondary outcomes, including intraoperative complications, infection rates, pain levels, and post operative hospital stay durations.
Detailed description
In general surgery, the management of ventral abdominal hernias characterized by the protrusion of tissue through weaknesses in the abdominal wall presents significant challenges, particularly when dealing with large ventral hernias, defined as those ≥10 cm or those under tension if closed primarily.
Incisional hernias, a specific subset of ventral hernias, add to the complexity of repair.
While the Intraperitoneal Onlay Mesh (IPOM) technique is noted for its reduced surgical and postoperative complications and lower reoperation rates, it also suffers from high costs, limited availability of specialized meshes like dynamesh, and increased intraoperative complications.
Alternatively, the modified open sublay technique, which employs a primary retro-muscular fascial repair and uses an affordable polypropylene mesh, offers a promising and cost effective solution with potential for a tension free repair.
This thesis aims to evaluate and compare these techniques to identify the most effective approach for large ventral hernia repair, balancing surgical outcomes, and complication rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Group (A) modified sublay hernioplasty: | Active comparator | Procedure: Ventral hernia repairIn the classic sublay hernioplasty technique, the hernia sac remains unopened. The procedure involves dissection of the posterior rectus sheath, which is then sutured at the midline. A mesh is placed behind the rectus muscle and in front of the posterior rectus sheath. Subsequently, the rectus muscle and anterior rectus sheath are sutured together at the midline, introducing tension to the repair. Conversely, the modified sublay hernioplasty technique follows a similar approach but with a key difference: the rectus muscle and anterior rectus sheath are left undisturbed without suturing them together. This modification aims to achieve a tension free repair, potentially reducing complications and enhancing overall outcomes. |
| Group (B) IPOM: | Active comparator | Procedure: Ventral hernia repairThe hernia repair procedure involved several key steps. First, the hernial sac was fully exposed and completely removed. Following this, a synthetic mesh was placed internally, covering the defect with overlapping edges to ensure adequate reinforcement. The mesh was then fixed to the anterior abdominal wall using sutures, which were applied through the supporting layers of the abdominal wall to secure the mesh in place. Preoperatively, all patients underwent comprehensive general and local examinations, routine laboratory blood tests, and abdominal ultrasound to evaluate the size of the hernia defect. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age (18-70) years, both sexes.
- Fitness for surgery.
- Patients with uncomplicated ventral hernia.
- Large anterior abdominal wall defect.
Key exclusion criteria (5 listed)
- Patients don't fit for general anesthesia due to sever co-morbidity.
- Patients with complicated ventral hernia.
- Patient refusal of surgical intervention.
- History of bleeding disorders.
- Pregnancy in female patients
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 |
|---|---|---|
| Ventral hernia repairComparative between both techniques | Procedure or surgery | Group (A) modified sublay hernioplasty:, Group (B) IPOM: |
Primary outcome
-Recurrence rate one year post operative.
Time frame: 1 year postoperative
Number of recurrent cases
1 secondary outcome
1-infection rates(number of cases) 2-pain level( according to Visual Analog Score for pain) 3-post operative hospital stay duration(number of days) 4-intra and post operative complications(as iatrogenic injury and adhesions).
Time frame: 1 year postoperative
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 26 Oct 2024.
- Background: PubMed 30604264Kockerling F, Simon T, Adolf D, Kockerling D, Mayer F, Reinpold W, Weyhe D, Bittner R. Laparoscopic IPOM versus open sublay technique for elective incisional hernia repair: a registry-based, propensity score-matched comparison of 9907 patients. Surg Endosc. 2019 Oct;33(10):3361-3369. doi: 10.1007/s00464-018-06629-2. Epub 2019 Jan 2.
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SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
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.
Ahmed M Abdallah, Doctor contact
Questions about this trial
What is this clinical trial studying?
A study testing Ventral hernia repair in people with Ventral Hernia, run by Ahmed Kahlawy Mahrous Mohamed.
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 4 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: opening soon, as of the sponsor's last update on 26 Oct 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 Ahmed K Mahrous, Resident doctor (01064620839, Ahmed.16311091@med.any.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Recurrence rate one year post operative. (time frame: 1 year postoperative). 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 NCT06643234, 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 26 Oct 2024.