Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty

Inguinal Hernia Clinical Trial

Official title:

Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258317
• Other study ID #: inguinal hernioplasty
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: March 2027

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Mina M George
• Phone: 01021306788
• Email: minamakram1397[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia, Inguinal
• Hernioplasty
• Inguinal Hernia
• Laparoscopic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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