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

NCT ID: NCT05420376

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-16

Study Completion Date

2023-06-16

Brief Summary

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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.

Detailed Description

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Conditions

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Hernia, Inguinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Whole Mesh

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

Group Type ACTIVE_COMPARATOR

Split Mesh

Intervention Type PROCEDURE

TEP repair of inguinal hernias using either split or whole mesh

Split Mesh

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.

Group Type ACTIVE_COMPARATOR

Split Mesh

Intervention Type PROCEDURE

TEP repair of inguinal hernias using either split or whole mesh

Interventions

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Split Mesh

TEP repair of inguinal hernias using either split or whole mesh

Intervention Type PROCEDURE

Other Intervention Names

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Whole mesh

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Erol Aydın

General Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Erol Aydın, MD

Role: CONTACT

+905322546001

Facility Contacts

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Erol AYDIN, MD

Role: primary

+90 5322546001

Other Identifiers

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569874

Identifier Type: -

Identifier Source: org_study_id

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