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Study of Laparoscopic Inguinal Hernia Repair

NCT ID: NCT02920307

Last Updated: 2016-09-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-09-30

Brief Summary

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Although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.

Detailed Description

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A randomized prospective study was conducted. Four groups of patients were constituted: (1) TEP with mesh fixation (2) TEP without fixation, (3) TAPP with mesh fixation, (4) TAPP without fixation. 120 patients were randomized to each group. The principal outcomes assessed were postoperative chronic groin pain assessed by visual analogue pain scale (VAS), hernia recurrence, other morbidity rates and hospital costs. Patients were reviewed in outpatient unit at 1 week and at 1, 6, 12 and 24 months.

Conditions

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Hernia, Inguinal Inguinal Hernia, Direct Inguinal Hernia, Indirect Hernia, Femoral Recurrence Neuralgia, Atypical Neuralgia, Ilioinguinal Neuralgia, Iliohypogastric Nerve

Keywords

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laparoscopic inguinal hernia repair total extraperitoneoscopic hernia repair transabdominal preperitoneal hernia repair inguinal hernia laparoscopy hernia repair herniorraphy laparoscopic surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TEP without fixation

Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair without mesh fixation

Group Type EXPERIMENTAL

TEP without fixation

Intervention Type PROCEDURE

Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair

TEP with fixation

Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair

Group Type ACTIVE_COMPARATOR

TEP with fixation

Intervention Type PROCEDURE

Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair

TAPP without fixation

Standard transabdominal preperitoneal (TAPP) hernia repair without mesh fixation

Group Type EXPERIMENTAL

TAPP without fixation

Intervention Type PROCEDURE

Standard transabdominal preperitoneal (TAPP) inguinal hernia repair without mesh fixation

TAPP with fixation

Standard transabdominal preperitoneal (TAPP) hernia repair

Group Type ACTIVE_COMPARATOR

TAPP with fixation

Intervention Type PROCEDURE

Standard transabdominal preperitoneal (TAPP) inguinal hernia repair

Interventions

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TEP without fixation

Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair

Intervention Type PROCEDURE

TEP with fixation

Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair

Intervention Type PROCEDURE

TAPP without fixation

Standard transabdominal preperitoneal (TAPP) inguinal hernia repair without mesh fixation

Intervention Type PROCEDURE

TAPP with fixation

Standard transabdominal preperitoneal (TAPP) inguinal hernia repair

Intervention Type PROCEDURE

Other Intervention Names

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TEP no fixation Standard TEP TAPP no fixation Standard TAPP

Eligibility Criteria

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Inclusion Criteria

* unilateral hernia
* uncomplicated hernia
* medical fitness for general anesthesia

Exclusion Criteria

* unfit for general anesthesia
* complicated hernia
* uncorrectable coagulopathy
* BMI \> 35
* concomitant pathologies requiring simultaneous surgery
* bilateral hernia
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role collaborator

Bahçeşehir University

OTHER

Sponsor Role collaborator

Medical Park Gaziantep Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Kaplan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Kaplan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bahçeşehir Üniversitesi Tıp Fakültesi

Onder Ozcan, M.D.

Role: STUDY_CHAIR

Mugla University, School of Medicine

Locations

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Medical Park Gaziantep Hospital

Gaziantep, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MK-002-LHR

Identifier Type: -

Identifier Source: org_study_id