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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06258317
Other study ID # inguinal hernioplasty
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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