Ventral HerniaNCT06255314
Minimally Invasive Techniques in Ventral Hernioplasty
A study testing ventral hernia repair in people with Ventral Hernia, run by Assiut University at 1 site in Egypt.
Trial summary
1. Review the surgical outcome of different techniques using extraperitoneal ventral hernia repair regarding postoperative pain. wound infection ,hospital stay , recurrence ,mesh migration and mesh induced visceral complications. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2024to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Able to give informed consent for inclusion in the study
- Age of the patient : above 18 years
- Any type of ventral hernia including umbilical,paraumbilical,epigastric,spigelian and incisional hernias
Who cannot join
- • Patients with inguinal hernia.
- Strangulated or obstructed hernia.
- Previous mesh hernia repair.
- Loss of abdominal domain.
- Infected or contaminated field.
- Defect size more than 10cm.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of medicine, Assiut University
Asyut, 71515
samir ammar, MD, 01141459567, samirahmed22@aun.edu.eg
About this study
Official title: Evaluation of Minimally Invasive Ventral Hernioplasty With Extraperitoneal Mesh Placement
- Review the surgical outcome of different techniques using extraperitoneal ventral hernia repair regarding postoperative pain. wound infection ,hospital stay , recurrence ,mesh migration and mesh induced visceral complications.
- Reviewing advantages and drawbacks of each surgical technique regarding feasibility ,cost effectiveness and technical difficulties
Read the detailed description
The laparoscopic ventral hernia repair was first introduced by LeBlanc and Booth in the early 1990s . Since its introduction, it has continued to evolve and has become an important option in the hernia surgeon's armamentarium. However, only 27.4% of ventral hernia repairs are performed laparoscopically, likely because of the relatively advanced nature of this procedure and because all hernias may not be suitable for a laparoscopic approach. Using current techniques, numerous studies have documented the safety and efficacy of this approach. Some data suggest that the laparoscopic approach results in a shorter hospital stay and lower recurrence rates compared with open approaches. However, pain may still be significant after laparoscopic repairs and there are not significant advantages from this standpoint. Nonetheless, it is well accepted that the primary advantage of the laparoscopic approach is that wound infections are less frequent compared with open approaches .LeBlanc and Booth in 1993 first reported application of intra-peritoneal onlay mesh (IPOM) for ventral and incisional hernia, However the technique requires expensive fixation devices which may cause acute and chronic pain .The laparoscopic groin hernia repair using synthetic mesh in TEP or TAPP are acceptable surgical techniques today These techniques are rarely associated with mesh induced complications, the reason being extraperitoneal placement of synthetic mesh. It is apparent that despite great progress in mesh technology, nearly all types of meshes have been found to produce a varying level of adhesion or tissue reaction, regardless of the material and coating used. Preoperatively unpredictable, a mesh-induced visceral complication may occur in some patients to produce severe reaction or major mesh-related adverse events.The incitation to develop certain novel minimally invasive techniques that enables researchers to bring the mesh out of abdominal cavity has been an exciting trend in laparoscopic hernia repair.
- 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
Laparoscopic transabdominal retromuscular repair is a minimally invasive approach to the open Rives Stoppa retromuscular sublay repair for ventral hernia.
In ventral hernia repair, it relies on initiation of dissection in one retrorectus space and then crossover to the contralateral retrorectus space The sublay mesh technique is an open surgical procedure for ventral and incisional hernias
| Study group | Role | What they receive |
|---|---|---|
| trans abdominal retromusclar laparoscopic ventral hernia repar | Experimental | Not described Receives: Procedure: ventral hernia repair |
| enhanced view totally extraperitoneal laparoscopic ventral hernia repair | Experimental | Not described Receives: Procedure: ventral hernia repair |
| open sublay ventral hernia repair | Experimental | Not described Receives: Procedure: ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Measured: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair.
Intra operative injuries including bowel or vascular injuries
Measured: intra operative
Secondary outcomes (5)
• Surgical site infection
Measured: postoperative up to 1month
• Surgical site occurrence of hematoma ,seroma, necrosis
Measured: : 30 days
• Hernia recurrence
Measured: : 1year
Cost effectiveness
cost of polyprolene mesh compared to composite mesh by egyptian pound
Measured: : 6months
•Rate of mesh related complication such as bowel erosion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ventral 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ashraf Mohamed Badr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255314
- Sponsor's protocol ID
- laparoscopic ventral hernia
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
LeBlanc KA, Booth WV. Laparoscopic repair of incisional abdominal hernias using expanded polytetrafluoroethylene: preliminary findings. Surg Laparosc Endosc. 1993 Feb;3(1):39-41.
PubMed 8258069Colavita PD, Tsirline VB, Belyansky I, Walters AL, Lincourt AE, Sing RF, Heniford BT. Prospective, long-term comparison of quality of life in laparoscopic versus open ventral hernia repair. Ann Surg. 2012 Nov;256(5):714-22; discussion 722-3. doi: 10.1097/SLA.0b013e3182734130.
PubMed 23095614Jin J, Rosen MJ. Laparoscopic versus open ventral hernia repair. Surg Clin North Am. 2008 Oct;88(5):1083-100, viii. doi: 10.1016/j.suc.2008.05.015.
PubMed 18790156Golani S, Middleton P. Long-term follow-up of laparoscopic total extraperitoneal (TEP) repair in inguinal hernia without mesh fixation. Hernia. 2017 Feb;21(1):37-43. doi: 10.1007/s10029-016-1558-7. Epub 2016 Dec 26.
PubMed 28025740Muschalla F, Schwarz J, Bittner R. Effectivity of laparoscopic inguinal hernia repair (TAPP) in daily clinical practice: early and long-term result. Surg Endosc. 2016 Nov;30(11):4985-4994. doi: 10.1007/s00464-016-4843-8. Epub 2016 Mar 16.
PubMed 26983436Tung KLM, Cheung HYS, Tang CN. Non-healing enterocutaneous fistula caused by mesh migration. ANZ J Surg. 2018 Jan;88(1-2):E73-E74. doi: 10.1111/ans.13253. Epub 2015 Aug 5. No abstract available.
PubMed 26246228
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Minimally Invasive Ventral Hernioplasty With Extraperitoneal Mesh Placement
- ClinicalTrials.gov ID
- NCT06255314
- Acronym / sponsor ID
- laparoscopic ventral hernia
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 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.
- Review the surgical outcome of different techniques using extraperitoneal ventral hernia repair regarding postoperative pain. wound infection ,hospital stay , recurrence ,mesh migration and mesh induced visceral complications.
- Reviewing advantages and drawbacks of each surgical technique regarding feasibility ,cost effectiveness and technical difficulties
Detailed description
The laparoscopic ventral hernia repair was first introduced by LeBlanc and Booth in the early 1990s . Since its introduction, it has continued to evolve and has become an important option in the hernia surgeon's armamentarium. However, only 27.4% of ventral hernia repairs are performed laparoscopically, likely because of the relatively advanced nature of this procedure and because all hernias may not be suitable for a laparoscopic approach. Using current techniques, numerous studies have documented the safety and efficacy of this approach. Some data suggest that the laparoscopic approach results in a shorter hospital stay and lower recurrence rates compared with open approaches. However, pain may still be significant after laparoscopic repairs and there are not significant advantages from this standpoint. Nonetheless, it is well accepted that the primary advantage of the laparoscopic approach is that wound infections are less frequent compared with open approaches .LeBlanc and Booth in 1993 first reported application of intra-peritoneal onlay mesh (IPOM) for ventral and incisional hernia, However the technique requires expensive fixation devices which may cause acute and chronic pain .The laparoscopic groin hernia repair using synthetic mesh in TEP or TAPP are acceptable surgical techniques today These techniques are rarely associated with mesh induced complications, the reason being extraperitoneal placement of synthetic mesh. It is apparent that despite great progress in mesh technology, nearly all types of meshes have been found to produce a varying level of adhesion or tissue reaction, regardless of the material and coating used. Preoperatively unpredictable, a mesh-induced visceral complication may occur in some patients to produce severe reaction or major mesh-related adverse events.The incitation to develop certain novel minimally invasive techniques that enables researchers to bring the mesh out of abdominal cavity has been an exciting trend in laparoscopic hernia repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| trans abdominal retromusclar laparoscopic ventral hernia repar | Experimental | Procedure: ventral hernia repair |
| enhanced view totally extraperitoneal laparoscopic ventral hernia repair | Experimental | Procedure: ventral hernia repair |
| open sublay ventral hernia repair | Experimental | Procedure: ventral hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Able to give informed consent for inclusion in the study
Key exclusion criteria (6 listed)
- • Patients with inguinal hernia.
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 repairLaparoscopic transabdominal retromuscular repair is a minimally invasive approach to the open Rives Stoppa retromuscular sublay repair for ventral hernia. In ventral hernia repair, it relies on initiation of dissection in one retrorectus space and then crossover to the contralateral retrorectus space The sublay mesh technique is an open surgical procedure for ventral and incisional hernias | Procedure or surgery | enhanced view totally extraperitoneal laparoscopic ventral hernia repair, open sublay ventral hernia repair, trans abdominal retromusclar laparoscopic ventral hernia repar |
Primary outcome
Operative time
Time frame: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair.
Intra operative injuries including bowel or vascular injuries
Time frame: intra operative
5 secondary outcomes
• Surgical site infection
Time frame: postoperative up to 1month
• Surgical site occurrence of hematoma ,seroma, necrosis
Time frame: : 30 days
• Hernia recurrence
Time frame: : 1year
Cost effectiveness
Time frame: : 6months
•Rate of mesh related complication such as bowel erosion
Time frame: 1 year
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 13 Feb 2024.
- Background: PubMed 8258069LeBlanc KA, Booth WV. Laparoscopic repair of incisional abdominal hernias using expanded polytetrafluoroethylene: preliminary findings. Surg Laparosc Endosc. 1993 Feb;3(1):39-41.
- Background: PubMed 23095614Colavita PD, Tsirline VB, Belyansky I, Walters AL, Lincourt AE, Sing RF, Heniford BT. Prospective, long-term comparison of quality of life in laparoscopic versus open ventral hernia repair. Ann Surg. 2012 Nov;256(5):714-22; discussion 722-3. doi: 10.1097/SLA.0b013e3182734130.
- Background: PubMed 18790156Jin J, Rosen MJ. Laparoscopic versus open ventral hernia repair. Surg Clin North Am. 2008 Oct;88(5):1083-100, viii. doi: 10.1016/j.suc.2008.05.015.
- Background: PubMed 28025740Golani S, Middleton P. Long-term follow-up of laparoscopic total extraperitoneal (TEP) repair in inguinal hernia without mesh fixation. Hernia. 2017 Feb;21(1):37-43. doi: 10.1007/s10029-016-1558-7. Epub 2016 Dec 26.
- Background: PubMed 26983436Muschalla F, Schwarz J, Bittner R. Effectivity of laparoscopic inguinal hernia repair (TAPP) in daily clinical practice: early and long-term result. Surg Endosc. 2016 Nov;30(11):4985-4994. doi: 10.1007/s00464-016-4843-8. Epub 2016 Mar 16.
- Background: PubMed 26246228Tung KLM, Cheung HYS, Tang CN. Non-healing enterocutaneous fistula caused by mesh migration. ANZ J Surg. 2018 Jan;88(1-2):E73-E74. doi: 10.1111/ans.13253. Epub 2015 Aug 5. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventral hernia repair in people with Ventral 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 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: opening soon, as of the sponsor's last update on 13 Feb 2024. 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?
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 mohamed badr (01060624371, akhel93@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair.). 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?
On the ClinicalTrials.gov record for NCT06255314, which also lists 6 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 13 Feb 2024.