QOL in Incarcerated Inguinal Hernias: TAPP Vs Open Repair

Overview

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

Full Title of Study: “The Comparison of the Quality of Life and Outcomes in Patient’s With Incarcerated Inguinal Hernias: Laparoscopic Transabdominal Pre-peritoneal (TAPP) Versus Modified Lichtenstein Hernioplasty”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2017

Detailed Description

Patients presenting with incarcerated 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

  • Procedure: Open modified Lichtenstein repair
    • Open Lichtenstein Hernioplasty
  • Procedure: Laparoscopic TAPP inguinal hernia repair
    • Laparoscopic TAPP Hernioplasty

Arms, Groups and Cohorts

  • Active Comparator: Open modified Lichtenstein repair
  • Active Comparator: Laparoscopic TAPP inguinal hernia repair

Clinical Trial Outcome Measures

Primary Measures

  • Quality of life scores as measured by Carolinas Comfort Scale
    • Time Frame: 12 months
    • Carolina Comfort Scale during the duration of follow-up

Secondary Measures

  • Operating Time in Minutes
    • Time Frame: 12 months
    • Comparing the duration of operation between open and laparoscopic surgeries.
  • Duration of Hospitalization in Days
    • Time Frame: 12 months
    • Comparing the duration of post operative stay between open and laparoscopic surgeries.
  • Recurrence of Hernia after Operation
    • Time Frame: 12 monthts
    • Comparing the recurrences between open and laparoscopic surgeries.

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years of age and older – Both genders – Unilateral inguinal hernias – Incarcerated inguinal hernias – Elective setting Exclusion Criteria:

  • Anaesthesiologists) Grade > 2 – Recurrence – Inguinal-scrotal hernias – Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery – Pregnancy – Refusal for general anaesthesia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sarawak General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Siow Sze Li, Dr – Sarawak General Hospital

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