Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty

NCT ID: NCT06258317

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2027-03-31

Brief Summary

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.

Conditions

Laparoscopic; Inguinal Hernia; Hernioplasty

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mesh fixation

Procedure/Surgery: fixation of conventional polypropylene mesh. This group includes patients with fixation of conventional polypropylene mesh.

Group Type: EXPERIMENTAL

fixation of conventional polypropylene mesh

Intervention Type: PROCEDURE

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.

Non-mesh fixation

Procedure/Surgery: non-fixation of the mesh. This group includes patients without fixation of the mesh.

Group Type: EXPERIMENTAL

fixation of conventional polypropylene mesh

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mina Makram George

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed A Rizk

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Mina M George

Role: CONTACT

minamakram1397@gmail.com

01021306788

References

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.

Reference Type: BACKGROUND

PMID: 30209805 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28170080 (View on PubMed)

Other Identifiers

inguinal hernioplasty

Identifier Type: -

Identifier Source: org_study_id