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Not yet recruiting NCT06258317

Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty

No phase Interventional Laparoscopic Inguinal Hernia Hernioplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fixation of conventional polypropylene mesh.
Who it may be relevant to
Registry conditions: Laparoscopic, Inguinal Hernia, Hernioplasty. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Inguinal hernia is one of the most common types of abdominal hernias. Laparoscopic hernioplasty of inguinal hernia is a good alternative to traditional open repairs even in simple unilateral primary inguinal hernia in terms of decrease post operative pain and complications with comparable recurrence rates.Two techniques are described in laparoscopic hernioplasty and have been extensively studied in randomised trials. The totally extraperitoneal (TEP) approach is more widely used than the transabdominal preperitoneal (TAPP) approach. In this study we will compare between the results of mesh fixation and non fixation as regard operative and postoperative data.

Interventions

  • Procedure fixation of conventional polypropylene mesh
    By fixation of the polyprolene mesh,patients will be divided into two groups: Group 1 includes patients with fixation of conventional polypropylene mesh. Group 2 includes patients without fixation of the mesh.

Primary outcome measures

  • Comparing fixation of conventional polypropylene mesh versus non fixation of 3D max mesh (anatomically oriented mesh) in laparoscopic trans-abdominal properitoneal (TAPP) inguinal hernia repair [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Any male or female above 18 years old that has uncomplicated inguinal hernia

Exclusion criteria

  • Patients with contraindications to use laparoscopy as cardiac or immunocompromised patients.
  • Patients who are difficult to follow up.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Lockhart K, Dunn D, Teo S, Ng JY, Dhillon M, Teo E, van Driel ML. Mesh versus non-mesh for inguinal and femoral hernia repair. Cochrane Database Syst Rev. 2018 Sep 13;9(9):CD011517. doi: 10.1002/14651858.CD011517.pub2. PMID 30209805
  • Sun P, Cheng X, Deng S, Hu Q, Sun Y, Zheng Q. Mesh fixation with glue versus suture for chronic pain and recurrence in Lichtenstein inguinal hernioplasty. Cochrane Database Syst Rev. 2017 Feb 7;2(2):CD010814. doi: 10.1002/14651858.CD010814.pub2. PMID 28170080

Identifiers

NCT: NCT06258317 · inguinal hernioplasty

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗