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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05420376
Enrollment
80
Registered
2022-06-15
Start date
2022-06-16
Completion date
2023-06-16
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Inguinal

Keywords

Laparoscopic Inguinal Hernia, Laparoscopic Hernia, Whole Mesh, Split Mesh, TAP, TEPP, Inguinal hernia

Brief 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.

Interventions

PROCEDURESplit Mesh

TEP repair of inguinal hernias using either split or whole mesh

Sponsors

Istanbul Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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,

Design outcomes

Primary

MeasureTime frameDescription
Carolinas Comfort Scale values6 monthDifferences 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.
Recurrence rates6 monthDifferences in recurrence rates in patients who use whole meshes and those who use split meshes.

Secondary

MeasureTime frameDescription
Recurrence rates6 monthDifference in recurrence rates at 6 months in patients who use whole meshes and those who use split meshes.

Countries

Turkey (Türkiye)

Contacts

Primary ContactErol Aydın, MD
erolay@gmail.com+905322546001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026