Lichtenstein Versus TAPP and TEP in Groin Hernioplasty

Inguinal Hernia Clinical Trial

— TAPP&TEP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02928146
• Other study ID #: Lichtenstein vs TAPP/TEP
• Status: Not yet recruiting
• Phase: N/A
• First received: October 6, 2016
• Last updated: October 6, 2016
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: October 2016
• Source: Jagiellonian University
• Contact: Miroslaw Szura, MD, PhD
• Phone: 609210030
• Email: msszura[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Hernia Repair

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Miroslaw Szura	Holy Jan Grande Boni Fratres Hospital in Krakow, Jagiellonian University Medical College, Stefan Zeromski Hospital in Kraków

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of the severity of pain according to VAS (visual analogue scale)		1 year after surgery	No
Other	Quality of life.		Prior to surgery, 1 and 6 months after the operation using SF-36 questionnaire.	No
Primary	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	No
Secondary	The frequency of conversions (from laparoscopic to open approach)		1 year	No