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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06197854
Other study ID # Mesh in incisional hernia
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2024
Est. completion date April 2025

Study information

Verified date December 2023
Source Assiut University
Contact Mark A Saad, Resident
Phone +201099489487
Email drmarkawny@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Onlay versus Sublay Mesh hernioplasty in management of incisional Hernia Comparative prospective study (Short term outcomes)


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hernioplasty
Surgical hernioplasty

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (7)

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

Outcome

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
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