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

Istanbul Training and Research Hospital

Status: Enrolling

Conditions: Hernia, Inguinal

Treatments: Procedure: Split Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT05420376

569874

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Whole Mesh

Active Comparator group

Description:

For the patients in the first group, the whole patch will be laid on the area without being fixed.

Treatment:

Procedure: Split Mesh

Split Mesh

Active Comparator group

Description:

The patients in the second group will be given a patch of the same size, but partially divided horizontally and wrapped around the spermatic cord.

Treatment:

Procedure: Split Mesh