Lichtenstein Versus TAPP and TEP in Groin Hernioplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lichtenstein technique

Lichtenstein inguinal hernia repair

Group Type ACTIVE_COMPARATOR

Hernia Repair

Intervention Type PROCEDURE

TAPP

Transabdominal preperitoneal (TAPP) approach for inguinal hernia repair

Group Type ACTIVE_COMPARATOR

Hernia Repair

Intervention Type PROCEDURE

TEP

Totally extraperitoneal (TEP) approach for inguinal hernia repair

Group Type ACTIVE_COMPARATOR

Hernia Repair

Intervention Type PROCEDURE

Interventions

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Hernia Repair

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No