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Not yet recruitingNCT06757998Updated Jan 3, 2025

On-lay Versus Pre-peritoneal Hernioplasty in Incisional Lumbar Hernia

An observational study in Lumbar Hernia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-01-03.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 60 Years
Sex
All
01

Study summary

To compare between the outcome of on-lay and pre-peritoneal techniques of hernioplasty in incisional lumbar hernia repair.

Read the detailed description

Lumbar hernia is found as a challenge even in the era of advanced medicine, due to its rarity which complicate its diagnosis and treatment[1]. Lumbar hernia is the protrusion of an organ intra-peritoneal or extra-peritoneal tissue through a congenital or acquired defect in the posterolateral abdominal wall[2]. Incisional Lumbar hernia is among the types of lumbar hernia that accounts for 25% of cases[3]. Post abdominal surgeries, the tissue strength can only regain 80% of its maximum tensile power under perfect conditions. Thus, each abdominal surgery is a predisposing factor for lumbar incisional hernia [4] Primary closure of the defect with sutures, has proven to have a high failure rate so the integration of the mesh in hernia repair has significantly flattened the recurrence curve. Taking the advantage of Laplace's law, the mesh aims to reinforce or bridge the defect and distribute the intra-abdominal pressure across the entire synthetic sheet rather than just the defect. [5] The two most used mesh placing techniques are on-lay and pre-peritoneal. Each method has its benefits and drawbacks. [6] Some surgeons outweigh the on-lay technique to avoid extensive dissection. Thus, it is a faster and easier technique; nevertheless, there are several local wound issues. [7] The pre-peritoneal method allows the surgeon to apply the mesh posterior to the fascial plane in front of the peritoneum. The latter technique is gaining popularity with time [8]

Literature are deficient in comparing on-lay and pre-peritoneal technique in the repair of incisional lumbar hernia.

02

Conditions studied

  • Lumbar Hernia

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03

In context

Hernia

257 studies on the registry are indexed under Hernia; 37 are open to participants now.

This study's planned enrollment of 30 is below the median of 120 across 85 observational studies indexed under Hernia.

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Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

  • Conventional Sample size of about 30 Cases about 15 cases of each group

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Incisional lumbar hernia
  • Recurrent lumbar hernia
  • Age more than 16 years old

Exclusion criteria

Exclusion Criteria:

  • Complicated lumbar hernia (irreducible, obstructed, strangulated hernia)
  • Denovo lumbar hernia
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • ProcedureMesh

    Compare between On-lay versus pre-peritoneal hernioplasty in incisional lumbar herni

06

What researchers measure

Primary outcomes

  1. Short term complications (Recurrence, Postoperative Seroma and skin infection.)

    Time frame: Two months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06757998
Lead sponsor
Assiut University
Responsible party
Ali fathy Ali (AFAli, Assiut University) — Principal investigator
First posted
Jan 3, 2025
Start date
Dec 29, 2024 (estimated)
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jan 3, 2025

Study contacts

Ali Fathy
Contact
alisfathy111@gmail.com
01030501745
Ibrahim Mostafa
Contact
dr_ibrahim.alouny@yahoo.com
01140024448

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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