Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty

NCT06258317 | Not Yet Recruiting

• 1 other identifier: inguinal hernioplasty
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

  Comparing fixation of conventional polypropylene mesh versus non fixation of 3D max mesh (anatomically oriented mesh) in laparoscopic transabdominal properitoneal (TAPP) inguinal hernia repair as regard operative and postoperative data.By following-up the patient while admitted post-operatively to check scrotal swelling by examination.After discharge contacting the patient 10 days, 20 days, one month, 2 months, 3 months, 6 months, one year, 2 years to check incidence of recurrence of hernia and return to normal life activities.

  Baseline

Study Arms (2)

Mesh fixation

EXPERIMENTAL

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

Procedure: fixation of conventional polypropylene mesh

Non-mesh fixation

EXPERIMENTAL

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

Procedure: fixation of conventional polypropylene mesh

Interventions

fixation of conventional polypropylene mesh 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.

Mesh fixation; Non-mesh fixation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed A Rizk

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mina M George

CONTACT

01021306788; minamakram1397@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: February 14, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 14, 2024

Record last verified: 2024-02