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

Comparison of Lichtenstein Versus TAPP and TEP Techniques for Inguinal Hernia Repair

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.

Study Overview

• Status: Unknown
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miroslaw Szura, MD, PhD; Phone Number: 609210030; Email: msszura@gmail.com
• Study Contact Backup: Name: Artur Pasternak, MD, PhD; Phone Number: 603642620; Email: artur.pasternak@uj.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lichtenstein technique; Lichtenstein inguinal hernia repair	Procedure: Hernia Repair
Active Comparator: TAPP; Transabdominal preperitoneal (TAPP) approach for inguinal hernia repair	Procedure: Hernia Repair
Active Comparator: TEP; Totally extraperitoneal (TEP) approach for inguinal hernia repair	Procedure: Hernia Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
The frequency of conversions (from laparoscopic to open approach)	1 year

Other Outcome Measures

Outcome Measure	Time Frame
Evaluation of the severity of pain according to VAS (visual analogue scale)	1 year after surgery
Quality of life.	Prior to surgery, 1 and 6 months after the operation using SF-36 questionnaire.

Collaborators and Investigators

• Sponsor: Miroslaw Szura
• Collaborators: Jagiellonian University; Holy Jan Grande Boni Fratres Hospital in Krakow; Stefan Zeromski Hospital in Kraków
• Investigators: Study Director: Miroslaw Szura, MD, PhD, Department of Experimental and Clinical Surgery, Jagiellonian University Medical College; Principal Investigator: Rafal Solecki, MD, PhD, Department of Experimental and Clinical Surgery, Jagiellonian University Medical College; Principal Investigator: Artur Pasternak, MD,PhD, Department of Anatomy, Jagiellonian University Medical College; Principal Investigator: Jakub Łomnicki, MD, Stefan Zeromski Hospital in Krakow

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (Estimate): October 10, 2016

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: TEP; Lichtenstein; TAPP; hernioplasty; syntethic mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: Lichtenstein vs TAPP/TEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED