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Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
inguinal hernia repair
Sponsored by
Kocaeli Derince Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring hernia, laparoscopic, Lichtenstein

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who were diagnosed with inguinal hernia (primary, recurrent, unilateral, bilateral)
  • American Society of Anesthesiologists (ASA) score of I and II
  • Gave informed consent to participate in the study

Exclusion Criteria:

  • Patients with scrotal, strangulated, or obstructed hernia
  • Periumbilical or subumbilical incision scar (median, right or left paramedian)
  • Undergoing prostatectomy or abdominal bladder surgery
  • Pfannenstiel incision scar
  • ASA score >3

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Laparoscopic Totally Extraperitoneal (TEP)

    Open tension-free mesh repair technique (Lichtenstein)

    Arm Description

    Patients who underwent Laparoscopic Totally Extraperitoneal (TEP) will be included in this group.

    Patients with open tension-free inguinal hernia(Lichtenstein) repair will be included in this group.

    Outcomes

    Primary Outcome Measures

    postoperative complication status
    number of patients with complications
    early period complication status
    number of patients with complications
    late period complication status
    number of patients with complications
    early recurrence rate
    number of patients with recurrence
    late recurrence rate
    number of patients with recurrence

    Secondary Outcome Measures

    Visual Analog Score for pain
    Units on a Scale; 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-9: severe pain, 10: worst pain possible.
    total analgesic requirement
    the number of analgesics used.
    time to return to work after surgery
    day
    early complication status
    Number of patients with complications

    Full Information

    First Posted
    July 31, 2022
    Last Updated
    August 14, 2022
    Sponsor
    Kocaeli Derince Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05504122
    Brief Title
    Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique
    Official Title
    Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique in Long-term Follow-up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2012 (Actual)
    Primary Completion Date
    December 31, 2014 (Actual)
    Study Completion Date
    January 1, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kocaeli Derince Education and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Open tension-free mesh repair (Lichtenstein) and laparoscopic totally extraperitoneal (TEP) repair are the most commonly preferred techniques for inguinal hernia surgery. There's still a debate going on about which of these two techniques (open versus laparoscopic) is effective. This prospective randomized study aimed at comparing the early and long-term results of these two techniques (TEP vs. Lichtenstein).
    Detailed Description
    Various studies comparing the laparoscopic totally extraperitoneal (TEP) and Lichtenstein techniques have been reported. These studies have shown that TEP repair is associated with less postoperative pain and faster recovery. However, there are different views on the long-term (recurrence, chronic pain, etc.) results of the two techniques. This study was designed to compare the short- and long-term outcomes of open tension-free mesh repair technique(Lichtenstein) and laparoscopic repair technique(TEP).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hernia, Inguinal
    Keywords
    hernia, laparoscopic, Lichtenstein

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Laparoscopic Totally Extraperitoneal (TEP)
    Arm Type
    Active Comparator
    Arm Description
    Patients who underwent Laparoscopic Totally Extraperitoneal (TEP) will be included in this group.
    Arm Title
    Open tension-free mesh repair technique (Lichtenstein)
    Arm Type
    Placebo Comparator
    Arm Description
    Patients with open tension-free inguinal hernia(Lichtenstein) repair will be included in this group.
    Intervention Type
    Procedure
    Intervention Name(s)
    inguinal hernia repair
    Intervention Description
    Patients who will undergo inguinal hernia repair will be divided into two groups(TEP versus Lichtenstein) according to the technique to be applied
    Primary Outcome Measure Information:
    Title
    postoperative complication status
    Description
    number of patients with complications
    Time Frame
    up to the first 10 days postoperatively
    Title
    early period complication status
    Description
    number of patients with complications
    Time Frame
    up to the first 3 months postoperatively
    Title
    late period complication status
    Description
    number of patients with complications
    Time Frame
    Postoperative 3rd to 84th month
    Title
    early recurrence rate
    Description
    number of patients with recurrence
    Time Frame
    up to the first 3 months postoperatively
    Title
    late recurrence rate
    Description
    number of patients with recurrence
    Time Frame
    Postoperative 3rd to 84th month
    Secondary Outcome Measure Information:
    Title
    Visual Analog Score for pain
    Description
    Units on a Scale; 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-9: severe pain, 10: worst pain possible.
    Time Frame
    postoperative 24th hour
    Title
    total analgesic requirement
    Description
    the number of analgesics used.
    Time Frame
    postoperative 1 to 10 days
    Title
    time to return to work after surgery
    Description
    day
    Time Frame
    Postoperative 3rd month
    Title
    early complication status
    Description
    Number of patients with complications
    Time Frame
    postoperative 1st month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who were diagnosed with inguinal hernia (primary, recurrent, unilateral, bilateral) American Society of Anesthesiologists (ASA) score of I and II Gave informed consent to participate in the study Exclusion Criteria: Patients with scrotal, strangulated, or obstructed hernia Periumbilical or subumbilical incision scar (median, right or left paramedian) Undergoing prostatectomy or abdominal bladder surgery Pfannenstiel incision scar ASA score >3
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Murat Coskun, MD
    Organizational Affiliation
    Kocaeli Derince Training and Research Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20395851
    Citation
    Langeveld HR, van't Riet M, Weidema WF, Stassen LP, Steyerberg EW, Lange J, Bonjer HJ, Jeekel J. Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial. Ann Surg. 2010 May;251(5):819-24. doi: 10.1097/SLA.0b013e3181d96c32.
    Results Reference
    background
    PubMed Identifier
    19106673
    Citation
    Eklund AS, Montgomery AK, Rasmussen IC, Sandbue RP, Bergkvist LA, Rudberg CR. Low recurrence rate after laparoscopic (TEP) and open (Lichtenstein) inguinal hernia repair: a randomized, multicenter trial with 5-year follow-up. Ann Surg. 2009 Jan;249(1):33-8. doi: 10.1097/SLA.0b013e31819255d0.
    Results Reference
    background
    PubMed Identifier
    22470068
    Citation
    O'Reilly EA, Burke JP, O'Connell PR. A meta-analysis of surgical morbidity and recurrence after laparoscopic and open repair of primary unilateral inguinal hernia. Ann Surg. 2012 May;255(5):846-53. doi: 10.1097/SLA.0b013e31824e96cf. Erratum In: Ann Surg. 2012 Aug;256(2):393.
    Results Reference
    background

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    Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique

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