Quality of Life of TEP vs Lichtenstein Hernioplasty

Sarawak General Hospital

Status: Unknown

Conditions: Inguinal Hernia

Treatments: Procedure: Open Lichtenstein Hernioplasty; Procedure: Laparoscopic TEP Hernioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02723045

NMRR-16-277-29543

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Open modified Lichtenstein repair

Active Comparator group

Description:

Patients will undergo open repair of their inguinal hernias

Treatment:

Procedure: Open Lichtenstein Hernioplasty

Laparoscopic TEP inguinal hernia repair

Active Comparator group

Description:

Patients will undergo laparoscopic repair of their inguinal hernias

Treatment:

Procedure: Laparoscopic TEP Hernioplasty