Quality of Life of TEP vs Lichtenstein Hernioplasty

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02723045
• Other study ID #: NMRR-16-277-29543
• Status: Not yet recruiting
• Phase: N/A
• First received: March 14, 2016
• Last updated: March 24, 2016
• Start date: April 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2016
• Source: Sarawak General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Open Lichtenstein Hernioplasty

• Laparoscopic TEP Hernioplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sarawak General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Carolina Comfort Scale	12 months	No
Secondary	Operating time		12 months	No
Secondary	Duration of hospitalization		12 months	No
Secondary	Complications		12 monthts	No
Secondary	Recurrence	Recurrence of hernia after repair	12 months	No