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Study of Laparoscopic Inguinal Hernia Repair

Primary Purpose

Hernia, Inguinal, Inguinal Hernia, Direct, Inguinal Hernia, Indirect

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

TEP without fixation

TEP with fixation

TAPP without fixation

TAPP with fixation

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring laparoscopic inguinal hernia repair, total extraperitoneoscopic hernia repair, transabdominal preperitoneal hernia repair, inguinal hernia, laparoscopy, hernia repair, herniorraphy, laparoscopic surgery

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical Park Gaziantep Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

TEP without fixation

TEP with fixation

TAPP without fixation

TAPP with fixation

Arm Description

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

Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair

Standard transabdominal preperitoneal (TAPP) hernia repair without mesh fixation

Standard transabdominal preperitoneal (TAPP) hernia repair

Outcomes

Primary Outcome Measures

Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS)

neuralgia, inguinal

Change from preoperative pain levels at 1 year assessed by the VAS

neuralgia, inguinal

Change from preoperative pain levels at 6 months assessed by the VAS

neuralgia, inguinal

Change from preoperative pain levels at 3 months assessed by the VAS

neuralgia, inguinal

Change from preoperative pain levels at 1 month assessed by the VAS

neuralgia, inguinal

Change from preoperative pain levels at 1 week assessed by the VAS

neuralgia, inguinal

Secondary Outcome Measures

Total hospital costs

consisted all costs of hospital stays and outpatient treatments

conversion rate

conversion to open surgery

recurrence rate

clinical and radiological diagnosed

rate of minor and major complications

it was assessed as; no complication, minor complications, major complications and complications needed reoperation

Full Information

NCT ID

NCT02920307

First Posted

September 22, 2016

Last Updated

September 29, 2016

Sponsor

Medical Park Gaziantep Hospital

Collaborators

Muğla Sıtkı Koçman University, Bahçeşehir University

1. Study Identification

Unique Protocol Identification Number

NCT02920307

Brief Title

Study of Laparoscopic Inguinal Hernia Repair

Official Title

Prospective, Randomized and Controlled Study Comparing Fixation Versus no Fixation of Mesh in Laparoscopic Inguinal Hernia Repair

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical Park Gaziantep Hospital

Collaborators

Muğla Sıtkı Koçman University, Bahçeşehir University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

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

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TEP without fixation

Arm Type

Experimental

Arm Description

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

Arm Title

TEP with fixation

Arm Type

Active Comparator

Arm Description

Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair

Arm Title

TAPP without fixation

Arm Type

Experimental

Arm Description

Standard transabdominal preperitoneal (TAPP) hernia repair without mesh fixation

Arm Title

TAPP with fixation

Arm Type

Active Comparator

Arm Description

Standard transabdominal preperitoneal (TAPP) hernia repair

Intervention Type

Procedure

Intervention Name(s)

TEP without fixation

Other Intervention Name(s)

TEP no fixation

Intervention Description

Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair

Intervention Type

Procedure

Intervention Name(s)

TEP with fixation

Other Intervention Name(s)

Standard TEP

Intervention Description

Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair

Intervention Type

Procedure

Intervention Name(s)

TAPP without fixation

Other Intervention Name(s)

TAPP no fixation

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

TAPP with fixation

Other Intervention Name(s)

Standard TAPP

Intervention Description

Standard transabdominal preperitoneal (TAPP) inguinal hernia repair

Primary Outcome Measure Information:

Title

Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS)

Description

neuralgia, inguinal

Time Frame

preoperative and postoperative 2nd year

Title

Change from preoperative pain levels at 1 year assessed by the VAS

Description

neuralgia, inguinal

Time Frame

preoperative and postoperative 1st year

Title

Change from preoperative pain levels at 6 months assessed by the VAS

Description

neuralgia, inguinal

Time Frame

preoperative and postoperative 6th month

Title

Change from preoperative pain levels at 3 months assessed by the VAS

Description

neuralgia, inguinal

Time Frame

preoperative and postoperative 3th month

Title

Change from preoperative pain levels at 1 month assessed by the VAS

Description

neuralgia, inguinal

Time Frame

preoperative and postoperative 1 month

Title

Change from preoperative pain levels at 1 week assessed by the VAS

Description

neuralgia, inguinal

Time Frame

preoperative and postoperative 1th week

Secondary Outcome Measure Information:

Title

Total hospital costs

Description

consisted all costs of hospital stays and outpatient treatments

Time Frame

up to 24 months

Title

conversion rate

Description

conversion to open surgery

Time Frame

through the first day

Title

recurrence rate

Description

clinical and radiological diagnosed

Time Frame

up to 24 months

Title

rate of minor and major complications

Description

it was assessed as; no complication, minor complications, major complications and complications needed reoperation

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mehmet Kaplan, M.D.

Organizational Affiliation

Bahçeşehir Üniversitesi Tıp Fakültesi

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Onder Ozcan, M.D.

Organizational Affiliation

Mugla University, School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Medical Park Gaziantep Hospital

City

Gaziantep

ZIP/Postal Code

27090

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Study of Laparoscopic Inguinal Hernia Repair

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