Comparison of Whole Mesh and Split Mesh Use in Laparoscopic Inguinal Hernia Repair

Hernia, Inguinal Clinical Trial

Official title:

Prospective Comparison of Whole Mesh and Split Mesh Use in Patient Groups Undergoing Laparoscopic Inguinal Hernia Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420376
• Other study ID #: 569874
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2022
• Est. completion date: June 16, 2023

Study information

• Verified date: July 2022
• Source: Istanbul Training and Research Hospital
• Contact: Erol Aydin, MD
• Phone: +905322546001
• Email: erolay[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

At least 80 patients who will undergo laparoscopic inguinal hernia repair surgery will be randomized into 2 groups. For the patients in the first group, the whole mesh will be laid on the area without being fixed. The patients in the second group will be given a mesh of the same size, but partially divided horizontally and wrapped around the spermatic cord. Demographic data of patients in both groups, quality of life data(Carolinas Comfort Scale) at postoperative 1st, 7th, 30th, 3rd and 6th months, postoperative pain (VAS values), clinical seroma rate, recurrence and other complications will be monitored. When the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical or/and radiological diagnosed primary inguinal hernia

• TEP or TAPP surgical methods

Exclusion Criteria:

• Recurrent hernias

• Patients with previous groin operations on same side

• Pregnant women

• Patients who did not accept to participate in the study

• ASA score of 3 or higher,

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• Split Mesh
TEP repair of inguinal hernias using either split or whole mesh

Locations

Country	Name	City	State
Turkey	Istanbul Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carolinas Comfort Scale values	Differences in postoperative pain and quality of life(Carolinas Comfort Scale at first month) in patients who use whole meshes and those who use split meshes.	6 month
Primary	Recurrence rates	Differences in recurrence rates in patients who use whole meshes and those who use split meshes.	6 month
Secondary	Recurrence rates	Difference in recurrence rates at 6 months in patients who use whole meshes and those who use split meshes.	6 month