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Quality of Life of TEP vs Lichtenstein Hernioplasty

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02723045
Enrollment
100
Registered
2016-03-30
Start date
2016-04-30
Completion date
2017-09-30
Last updated
2016-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

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.

Interventions

PROCEDUREOpen Lichtenstein Hernioplasty
PROCEDURELaparoscopic TEP Hernioplasty

Sponsors

Sarawak General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life12 monthsCarolina Comfort Scale

Secondary

MeasureTime frameDescription
Operating time12 months
Duration of hospitalization12 months
Complications12 monthts
Recurrence12 monthsRecurrence of hernia after repair

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026