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
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring TAPP, TEP, Lichtenstein, syntethic mesh, hernioplasty
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
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
NCT ID
NCT02928146
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
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
Learn more about this trial
Lichtenstein Versus TAPP and TEP in Groin Hernioplasty
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