Clinical trial NCT06197854: Onlay Versus Sublay Mesh in Incisional Hernia
Official title: Onlay Versus Sublay Hernioplasty in Management of Incisional Hernia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Incisional Hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient presenting with incisional hernia for elective hernioplasty that is Surgically Fit and match inclusion critiria

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Short term complications
timeFrame: 1 month
Secondary outcomes:
measure: Post operative complications
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
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.
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.
citation: 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.