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Lichtenstein Versus TAPP and TEP in Groin Hernioplasty (TAPP&TEP)

Primary Purpose

Inguinal Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hernia Repair
Sponsored by
Miroslaw Szura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring TAPP, TEP, Lichtenstein, syntethic mesh, hernioplasty

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • male
  • age: 18 - 65
  • planned inguinal hernia repair using synthetic implant
  • BMI range: 20-35 kg / m2
  • written informed consent

Exclusion Criteria:

  • prior midline laparotomy
  • contraindications for general anaesthesia
  • ASA > IV
  • cirrhosis (Child B or C) or ascites
  • active treatment with use of chemiotherapy
  • incarcerated hernia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Lichtenstein technique

    TAPP

    TEP

    Arm Description

    Lichtenstein inguinal hernia repair

    Transabdominal preperitoneal (TAPP) approach for inguinal hernia repair

    Totally extraperitoneal (TEP) approach for inguinal hernia repair

    Outcomes

    Primary Outcome Measures

    Post-operative complications associated with wound
    Wound infection with or without the need to remove the mesh, Wound necrosis, Hematoma or seroma in the wound.

    Secondary Outcome Measures

    The frequency of conversions (from laparoscopic to open approach)

    Full Information

    First Posted
    October 6, 2016
    Last Updated
    October 6, 2016
    Sponsor
    Miroslaw Szura
    Collaborators
    Jagiellonian University, Holy Jan Grande Boni Fratres Hospital in Krakow, Stefan Zeromski Hospital in Kraków
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02928146
    Brief Title
    Lichtenstein Versus TAPP and TEP in Groin Hernioplasty
    Acronym
    TAPP&TEP
    Official Title
    Comparison of Lichtenstein Versus TAPP and TEP Techniques for Inguinal Hernia Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    June 2018 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Miroslaw Szura
    Collaborators
    Jagiellonian University, Holy Jan Grande Boni Fratres Hospital in Krakow, Stefan Zeromski Hospital in Kraków

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to evaluate the effectiveness of various methods of inguinal hernia repair and to evaluate techniques of synthetic mesh fixation during laparoscopic and open hernia repair.
    Detailed Description
    In modern literature there is no conclusive evidence for the superiority of endoscopic over open inguinal hernia repair techniques, due to the lack of prospective, multicenter, randomized studies involving a sufficient number of patients. Both Lichtenstein and TAPP/TEP techniques are widely used and accepted methods of treatment. The clinical significance of this study is to show the differences in the incidence of perioperative complications, the evaluation of postoperative pain, full recovery time and improving the quality of life. The diagnosis of inguinal hernia will be based on a physical examination performed by an experienced surgeon based on the medical history of the patient and, if necessary, on ultrasound examination of the abdominal wall. Random assignment of patients to one of three treatment arms will take place the day before the surgery using computer-generated randomization list. The operating surgeon will be determined prior to randomization. Each patient before the study will receive complete information about the study which will be explained in detail regarding all planned procedures, the patient will obtain answers to any questions. After explaining any doubts the patient will sign the informed consent to participate in the study, in the presence of the investigator. Patients will be divided into three groups - TAPP, TEP and Lichtenstein method. Patients treated by TAPP and Lichtenstein will be further divided into subgroups - fixation glue or stitching - Lichtenstein method; fixation glue, tackers or implantation without fixation - TAPP method. Patients will receive preoperative antibiotic prophylaxis with a single dose of cephalosporin. Patients undergoing surgery will be hospitalized in the Department of Surgery until the first postop day. In justified cases, hospitalization will be extended.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inguinal Hernia
    Keywords
    TAPP, TEP, Lichtenstein, syntethic mesh, hernioplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lichtenstein technique
    Arm Type
    Active Comparator
    Arm Description
    Lichtenstein inguinal hernia repair
    Arm Title
    TAPP
    Arm Type
    Active Comparator
    Arm Description
    Transabdominal preperitoneal (TAPP) approach for inguinal hernia repair
    Arm Title
    TEP
    Arm Type
    Active Comparator
    Arm Description
    Totally extraperitoneal (TEP) approach for inguinal hernia repair
    Intervention Type
    Procedure
    Intervention Name(s)
    Hernia Repair
    Primary Outcome Measure Information:
    Title
    Post-operative complications associated with wound
    Description
    Wound infection with or without the need to remove the mesh, Wound necrosis, Hematoma or seroma in the wound.
    Time Frame
    30 days after surgery
    Secondary Outcome Measure Information:
    Title
    The frequency of conversions (from laparoscopic to open approach)
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    Evaluation of the severity of pain according to VAS (visual analogue scale)
    Time Frame
    1 year after surgery
    Title
    Quality of life.
    Time Frame
    Prior to surgery, 1 and 6 months after the operation using SF-36 questionnaire.

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: male age: 18 - 65 planned inguinal hernia repair using synthetic implant BMI range: 20-35 kg / m2 written informed consent Exclusion Criteria: prior midline laparotomy contraindications for general anaesthesia ASA > IV cirrhosis (Child B or C) or ascites active treatment with use of chemiotherapy incarcerated hernia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Miroslaw Szura, MD, PhD
    Phone
    609210030
    Email
    msszura@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Artur Pasternak, MD, PhD
    Phone
    603642620
    Email
    artur.pasternak@uj.edu.pl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Miroslaw Szura, MD, PhD
    Organizational Affiliation
    Department of Experimental and Clinical Surgery, Jagiellonian University Medical College
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Rafal Solecki, MD, PhD
    Organizational Affiliation
    Department of Experimental and Clinical Surgery, Jagiellonian University Medical College
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Artur Pasternak, MD,PhD
    Organizational Affiliation
    Department of Anatomy, Jagiellonian University Medical College
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jakub Łomnicki, MD
    Organizational Affiliation
    Stefan Zeromski Hospital in Krakow
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Lichtenstein Versus TAPP and TEP in Groin Hernioplasty

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