NCT06197854

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

December 26, 2023

Last Update Submit

December 26, 2023

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (1)

  • Short term complications

    (Recurrence, Post operative Pain, seroma and skin infection.)

    1 month

Secondary Outcomes (1)

  • Post operative complications

    1 month

Study Arms (2)

Sublay hernioplasty in incisional hernia

Group that will undergo Sublay hernioplasty in management of incisional hernia

Procedure: Hernioplasty

Onlay Hernioplasty in incisional hernia

Group that will undergo Onlay hernioplasty in management of incisional hernia

Procedure: Hernioplasty

Interventions

HernioplastyPROCEDURE

Surgical hernioplasty

Onlay Hernioplasty in incisional herniaSublay hernioplasty in incisional hernia

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Any patient presenting with incisional hernia for elective hernioplasty that is Surgically Fit and match inclusion critiria

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 30359827BACKGROUND

  • 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.

    PMID: 26563217BACKGROUND

  • 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.

    PMID: 28692907BACKGROUND

  • 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.

    PMID: 22170318BACKGROUND

  • 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.

    PMID: 21741517BACKGROUND

  • 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.

    PMID: 28009747BACKGROUND

  • 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.

    PMID: 25797746BACKGROUND

MeSH Terms

Conditions

Incisional Hernia

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Central Study Contacts

Mark A Saad, Resident

CONTACT

+201099489487drmarkawny@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 9, 2024

Study Start

January 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

January 9, 2024

Record last verified: 2023-12