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Clinical Trials/NCT02723045
NCT02723045
Unknown
Not Applicable

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

Sarawak General Hospital0 sites100 target enrollmentApril 2016
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ConditionsInguinal Hernia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inguinal Hernia
Sponsor
Sarawak General Hospital
Enrollment
100
Primary Endpoint
Quality of life
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
September 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Siow Sze Li

General Surgeon

Sarawak General Hospital

Eligibility 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Quality of life

Time Frame: 12 months

Carolina Comfort Scale

Secondary Outcomes

  • Operating time(12 months)
  • Complications(12 monthts)
  • Duration of hospitalization(12 months)
  • Recurrence(12 months)

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