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

Primary Purpose

Hernia, Inguinal

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Split Mesh

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring Laparoscopic Inguinal Hernia, Laparoscopic Hernia, Whole Mesh, Split Mesh, TAP, TEPP, Inguinal hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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,

Sites / Locations

Istanbul Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Whole Mesh

Split Mesh

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Recurrence rates

Differences in recurrence rates in patients who use whole meshes and those who use split meshes.

Secondary Outcome Measures

Recurrence rates

Difference in recurrence rates at 6 months in patients who use whole meshes and those who use split meshes.

Full Information

NCT ID

NCT05420376

First Posted

May 20, 2022

Last Updated

July 19, 2022

Sponsor

Istanbul Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05420376

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 16, 2022 (Actual)

Primary Completion Date

May 16, 2023 (Anticipated)

Study Completion Date

June 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia, Inguinal

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Whole Mesh

Arm Type

Active Comparator

Arm Description

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

Arm Title

Split Mesh

Arm Type

Active Comparator

Arm 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.

Intervention Type

Procedure

Intervention Name(s)

Split Mesh

Other Intervention Name(s)

Whole mesh

Intervention Description

TEP repair of inguinal hernias using either split or whole mesh

Primary Outcome Measure Information:

Title

Carolinas Comfort Scale values

Description

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.

Time Frame

6 month

Title

Recurrence rates

Description

Differences in recurrence rates in patients who use whole meshes and those who use split meshes.

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Recurrence rates

Description

Difference in recurrence rates at 6 months in patients who use whole meshes and those who use split meshes.

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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,

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Erol Aydın, MD

Phone

+905322546001

erolay@gmail.com

Facility Information:

Facility Name

Istanbul Training and Research Hospital

City

Istanbul

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erol AYDIN, MD

Phone

+90 5322546001

erolay@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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