Incisional Hernia Clinical Trial
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)
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | April 2025 |
| Est. primary completion date | March 2025 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
Cobb 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. — View Citation
Deeken 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. — View Citation
Hawn 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. — View Citation
Mathes 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. — View Citation
Rosen 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. — View Citation
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. — View Citation
Smietanski 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Short term complications | (Recurrence, Post operative Pain, seroma and skin infection.) | 1 month | |
| Secondary | Post operative complications | Superficial skin infection, seroma formation, recurrence and chronic abdominal discomfort. | 1 month |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06016426 -
Mass Closure vs Layer by Layer Closure
|
N/A | |
| Recruiting |
NCT05734222 -
Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias
|
N/A | |
| Enrolling by invitation |
NCT03105895 -
Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI
|
N/A | |
| Completed |
NCT01961687 -
A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
|
N/A | |
| Completed |
NCT02089958 -
Standardization of Laparoscopic Hernia Repair
|
N/A | |
| Completed |
NCT00998907 -
PDS*Plus and Wound Infections After Laparotomy
|
N/A | |
| Terminated |
NCT00498810 -
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
|
N/A | |
| Completed |
NCT04961346 -
RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair
|
N/A | |
| Terminated |
NCT03912662 -
ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention
|
N/A | |
| Recruiting |
NCT05620121 -
ACute Treatment of Incisional Ventral Hernia
|
||
| Recruiting |
NCT03561727 -
Risk Factors for Development of Incisional Hernia in Transverse Incisions
|
N/A | |
| Completed |
NCT03938688 -
Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation
|
N/A | |
| Not yet recruiting |
NCT05568238 -
Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen
|
N/A | |
| Not yet recruiting |
NCT02896686 -
Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure
|
Phase 4 | |
| Recruiting |
NCT02277262 -
PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)
|
Phase 4 | |
| Active, not recruiting |
NCT02328352 -
"BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation"
|
Phase 1/Phase 2 | |
| Suspended |
NCT01520168 -
Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management
|
N/A | |
| Recruiting |
NCT05579652 -
Change in Fascial Tension in Open Abdomens
|
||
| Active, not recruiting |
NCT03390764 -
Hernia After Colorectal Cancer Surgery
|
N/A | |
| Completed |
NCT02321059 -
Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia
|
N/A |