Quality of Life of TEP vs Lichtenstein Hernioplasty

Not Applicable

• Conditions: Inguinal Hernia
• Interventions: Procedure: Laparoscopic TEP Hernioplasty; Procedure: Open Lichtenstein Hernioplasty

• Registration Number: NCT02723045
• Lead Sponsor: Sarawak General Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-24
• Last Update Submitted: 2016-03-24
• Study First Posted: 2016-03-30
• Last Update Posted: 2016-03-30
• Study Start: 2016-04
• Primary Completion: 2016-10
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic TEP inguinal hernia repair	Laparoscopic TEP Hernioplasty	Patients will undergo laparoscopic repair of their inguinal hernias
Open modified Lichtenstein repair	Open Lichtenstein Hernioplasty	Patients will undergo open repair of their inguinal hernias

Primary Outcome Measures

Name	Time	Method
Quality of life	12 months	Carolina Comfort Scale

Secondary Outcome Measures

Name	Time	Method
Operating time	12 months
Complications	12 monthts
Duration of hospitalization	12 months
Recurrence	12 months	Recurrence of hernia after repair