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

December 27, 2024 updated by: Ali fathy Ali, Assiut University
To compare between the outcome of on-lay and pre-peritoneal techniques of hernioplasty in incisional lumbar hernia repair.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Short term complications (Recurrence, Postoperative Seroma and skin infection.)
Time Frame: Two months
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 29, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

December 27, 2024

First Submitted That Met QC Criteria

December 27, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 27, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hernioplasty in lumbar hernia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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