Lichtenstein Versus TAPP and TEP in Groin Hernioplasty

Not Applicable

• Conditions: Inguinal Hernia

• Registration Number: NCT02928146
• Lead Sponsor: Miroslaw Szura

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.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-06
• Last Update Submitted: 2016-10-06
• Study First Posted: 2016-10-10
• Last Update Posted: 2016-10-10
• Study Start: 2017-01
• Primary Completion: 2018-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Post-operative complications associated with wound	30 days after surgery	Wound infection with or without the need to remove the mesh, Wound necrosis, Hematoma or seroma in the wound.

Secondary Outcome Measures

Name	Time	Method
The frequency of conversions (from laparoscopic to open approach)	1 year