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Quality of Life of TEP vs Lichtenstein Hernioplasty

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ClinicalTrials.gov Identifier: NCT02723045
Recruitment Status : Unknown
Verified March 2016 by Siow Sze Li, Sarawak General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Siow Sze Li, Sarawak General Hospital

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

Condition or disease Intervention/treatment Phase
Inguinal Hernia Procedure: Open Lichtenstein Hernioplasty Procedure: Laparoscopic TEP Hernioplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Open modified Lichtenstein repair
Patients will undergo open repair of their inguinal hernias
Procedure: Open Lichtenstein Hernioplasty
Active Comparator: Laparoscopic TEP inguinal hernia repair
Patients will undergo laparoscopic repair of their inguinal hernias
Procedure: Laparoscopic TEP Hernioplasty



Primary Outcome Measures :
  1. Quality of life [ Time Frame: 12 months ]
    Carolina Comfort Scale


Secondary Outcome Measures :
  1. Operating time [ Time Frame: 12 months ]
  2. Duration of hospitalization [ Time Frame: 12 months ]
  3. Complications [ Time Frame: 12 monthts ]
  4. Recurrence [ Time Frame: 12 months ]
    Recurrence of hernia after repair



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Siow Sze Li, General Surgeon, Sarawak General Hospital
ClinicalTrials.gov Identifier: NCT02723045     History of Changes
Other Study ID Numbers: NMRR-16-277-29543
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal