Quality of Life of TEP vs Lichtenstein Hernioplasty

March 24, 2016 updated by: Siow Sze Li, Sarawak General Hospital

The Comparison of the Quality of Life and Outcomes in Patient's With Reducible Inguinal Hernias: Laparoscopic Totally Extra-peritoneal (TEP) Versus Modified Lichtenstein Hernioplasty

To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients presenting with reducible inguinal hernias will be randomized between open or laparoscopic repair groups. The primary outcome will be the quality of life scores. Patients will be followed-up for 12 months.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age and older
  • Both genders
  • Unilateral inguinal hernias
  • Reducible inguinal hernias
  • Elective setting

Exclusion Criteria

  • ASA Physical Status (American Society of Anaesthesiologists) Grade > 2
  • Recurrence
  • Inguinal-scrotal hernias
  • Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
  • Pregnancy
  • Refusal for general anaesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open modified Lichtenstein repair
Patients will undergo open repair of their inguinal hernias
Procedure: Open Lichtenstein Hernioplasty
Active Comparator: Laparoscopic TEP inguinal hernia repair
Patients will undergo laparoscopic repair of their inguinal hernias
Procedure: Laparoscopic TEP Hernioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 12 months
Carolina Comfort Scale
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating time
Time Frame: 12 months
12 months
Duration of hospitalization
Time Frame: 12 months
12 months
Complications
Time Frame: 12 monthts
12 monthts
Recurrence
Time Frame: 12 months
Recurrence of hernia after repair
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarawak General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 30, 2016

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 24, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR-16-277-29543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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