Incisional HerniaNCT06197854
Onlay Versus Sublay Mesh in Incisional Hernia
An observational study of Incisional Hernia, run by Assiut University.
Trial summary
Onlay versus Sublay Mesh hernioplasty in management of incisional Hernia Comparative prospective study (Short term outcomes) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Hernioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Apr 2025
- Phase
- Observational
- 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 60 years
- All sexes
- Adult
Study population: Any patient presenting with incisional hernia for elective hernioplasty that is Surgically Fit and match inclusion critiria
Who may be able to join
- Surgically Fit patients
- Patients presented with incisional Hernias
- Age between 18 to 60 years
- Cicatrized incisional hernia involving both muscle cutting and muscle splitting incisions
Who cannot join
- Surgically unfit patients
- Irreducible, obstructed, strangulated hernias
- Other Ventral hernias that not related to surgical incision.
- Huge hernias with wide abdominal wall defect and retracted abdominal wall muscles.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Onlay Versus Sublay Hernioplasty in Management of Incisional Hernia
Onlay versus Sublay Mesh hernioplasty in management of incisional Hernia Comparative prospective study (Short term outcomes)
Read the detailed description
Comparison between Short term outcomes (advantages and disadvantages) of sublay and onlay techniques in management of incisional hernia regarding :
- Short term complications (superficial skin infection, seroma formation , recurrence and chronic abdominal discomfort.)
- operative time , hospital stay , difficulty of technique.
- Conditions
- Incisional Hernia
- Being tested
- Hernioplasty
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HernioplastyProcedure or surgery
Surgical hernioplasty
| Study group | Role | What they receive |
|---|---|---|
| Sublay hernioplasty in incisional hernia | Group that will undergo Sublay hernioplasty in management of incisional hernia Receives: Procedure: Hernioplasty | |
| Onlay Hernioplasty in incisional hernia | Group that will undergo Onlay hernioplasty in management of incisional hernia Receives: Procedure: Hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term complications
(Recurrence, Post operative Pain, seroma and skin infection.)
Measured: 1 month
Secondary outcomes (1)
Post operative complications
Superficial skin infection, seroma formation, recurrence and chronic abdominal discomfort.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Awny Albeir Saad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197854
- Sponsor's protocol ID
- Mesh in incisional hernia
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schlosser KA, Arnold MR, Otero J, Prasad T, Lincourt A, Colavita PD, Kercher KW, Heniford BT, Augenstein VA. Deciding on Optimal Approach for Ventral Hernia Repair: Laparoscopic or Open. J Am Coll Surg. 2019 Jan;228(1):54-65. doi: 10.1016/j.jamcollsurg.2018.09.004. Epub 2018 Oct 22.
PubMed 30359827Mathes T, Walgenbach M, Siegel R. Suture Versus Mesh Repair in Primary and Incisional Ventral Hernias: A Systematic Review and Meta-Analysis. World J Surg. 2016 Apr;40(4):826-35. doi: 10.1007/s00268-015-3311-2.
PubMed 26563217Deeken CR, Lake SP. Mechanical properties of the abdominal wall and biomaterials utilized for hernia repair. J Mech Behav Biomed Mater. 2017 Oct;74:411-427. doi: 10.1016/j.jmbbm.2017.05.008. Epub 2017 May 6.
PubMed 28692907Smietanski M, Bury K, Tomaszewska A, Lubowiecka I, Szymczak C. Biomechanics of the front abdominal wall as a potential factor leading to recurrence with laparoscopic ventral hernia repair. Surg Endosc. 2012 May;26(5):1461-7. doi: 10.1007/s00464-011-2056-8. Epub 2011 Dec 15.
PubMed 22170318Hawn MT, Gray SH, Snyder CW, Graham LA, Finan KR, Vick CC. Predictors of mesh explantation after incisional hernia repair. Am J Surg. 2011 Jul;202(1):28-33. doi: 10.1016/j.amjsurg.2010.10.011.
PubMed 21741517Rosen MJ, Bauer JJ, Harmaty M, Carbonell AM, Cobb WS, Matthews B, Goldblatt MI, Selzer DJ, Poulose BK, Hansson BM, Rosman C, Chao JJ, Jacobsen GR. Multicenter, Prospective, Longitudinal Study of the Recurrence, Surgical Site Infection, and Quality of Life After Contaminated Ventral Hernia Repair Using Biosynthetic Absorbable Mesh: The COBRA Study. Ann Surg. 2017 Jan;265(1):205-211. doi: 10.1097/SLA.0000000000001601.
PubMed 28009747Cobb WS, Warren JA, Ewing JA, Burnikel A, Merchant M, Carbonell AM. Open retromuscular mesh repair of complex incisional hernia: predictors of wound events and recurrence. J Am Coll Surg. 2015 Apr;220(4):606-13. doi: 10.1016/j.jamcollsurg.2014.12.055. Epub 2015 Jan 28.
PubMed 25797746
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onlay Versus Sublay Hernioplasty in Management of Incisional Hernia
- ClinicalTrials.gov ID
- NCT06197854
- Acronym / sponsor ID
- Mesh in incisional hernia
- Conditions
- Incisional Hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 9 Jan 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.
Onlay versus Sublay Mesh hernioplasty in management of incisional Hernia Comparative prospective study (Short term outcomes)
Detailed description
Comparison between Short term outcomes (advantages and disadvantages) of sublay and onlay techniques in management of incisional hernia regarding :
- Short term complications (superficial skin infection, seroma formation , recurrence and chronic abdominal discomfort.)
- operative time , hospital stay , difficulty of technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublay hernioplasty in incisional hernia | – | Procedure: HernioplastyGroup that will undergo Sublay hernioplasty in management of incisional hernia |
| Onlay Hernioplasty in incisional hernia | – | Procedure: HernioplastyGroup that will undergo Onlay hernioplasty in management of incisional hernia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Any patient presenting with incisional hernia for elective hernioplasty that is Surgically Fit and match inclusion critiria
Key inclusion criteria (4 listed)
- Surgically Fit patients
- Patients presented with incisional Hernias
- Age between 18 to 60 years
- Cicatrized incisional hernia involving both muscle cutting and muscle splitting incisions
Key exclusion criteria (4 listed)
- Surgically unfit patients
- Irreducible, obstructed, strangulated hernias
- Other Ventral hernias that not related to surgical incision.
- Huge hernias with wide abdominal wall defect and retracted abdominal wall muscles.
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 |
|---|---|---|
| HernioplastySurgical hernioplasty | Procedure or surgery | Onlay Hernioplasty in incisional hernia, Sublay hernioplasty in incisional hernia |
Primary outcome
Short term complications
Time frame: 1 month
(Recurrence, Post operative Pain, seroma and skin infection.)
1 secondary outcome
Post operative complications
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 30359827Schlosser KA, Arnold MR, Otero J, Prasad T, Lincourt A, Colavita PD, Kercher KW, Heniford BT, Augenstein VA. Deciding on Optimal Approach for Ventral Hernia Repair: Laparoscopic or Open. J Am Coll Surg. 2019 Jan;228(1):54-65. doi: 10.1016/j.jamcollsurg.2018.09.004. Epub 2018 Oct 22.
- Background: PubMed 26563217Mathes T, Walgenbach M, Siegel R. Suture Versus Mesh Repair in Primary and Incisional Ventral Hernias: A Systematic Review and Meta-Analysis. World J Surg. 2016 Apr;40(4):826-35. doi: 10.1007/s00268-015-3311-2.
- Background: PubMed 28692907Deeken CR, Lake SP. Mechanical properties of the abdominal wall and biomaterials utilized for hernia repair. J Mech Behav Biomed Mater. 2017 Oct;74:411-427. doi: 10.1016/j.jmbbm.2017.05.008. Epub 2017 May 6.
- Background: PubMed 22170318Smietanski M, Bury K, Tomaszewska A, Lubowiecka I, Szymczak C. Biomechanics of the front abdominal wall as a potential factor leading to recurrence with laparoscopic ventral hernia repair. Surg Endosc. 2012 May;26(5):1461-7. doi: 10.1007/s00464-011-2056-8. Epub 2011 Dec 15.
- Background: PubMed 21741517Hawn MT, Gray SH, Snyder CW, Graham LA, Finan KR, Vick CC. Predictors of mesh explantation after incisional hernia repair. Am J Surg. 2011 Jul;202(1):28-33. doi: 10.1016/j.amjsurg.2010.10.011.
- Background: PubMed 28009747Rosen MJ, Bauer JJ, Harmaty M, Carbonell AM, Cobb WS, Matthews B, Goldblatt MI, Selzer DJ, Poulose BK, Hansson BM, Rosman C, Chao JJ, Jacobsen GR. Multicenter, Prospective, Longitudinal Study of the Recurrence, Surgical Site Infection, and Quality of Life After Contaminated Ventral Hernia Repair Using Biosynthetic Absorbable Mesh: The COBRA Study. Ann Surg. 2017 Jan;265(1):205-211. doi: 10.1097/SLA.0000000000001601.
- Background: PubMed 25797746Cobb WS, Warren JA, Ewing JA, Burnikel A, Merchant M, Carbonell AM. Open retromuscular mesh repair of complex incisional hernia: predictors of wound events and recurrence. J Am Coll Surg. 2015 Apr;220(4):606-13. doi: 10.1016/j.jamcollsurg.2014.12.055. Epub 2015 Jan 28.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia, 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 4 inclusion and 4 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 9 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark A Saad, Resident (+201099489487, drmarkawny@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term complications (time frame: 1 month). 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 NCT06197854, which also lists 7 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 9 Jan 2024.