Clinical trial NCT02928146: Lichtenstein Versus TAPP and TEP in Groin Hernioplasty
Official title: Comparison of Lichtenstein Versus TAPP and TEP Techniques for Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Keywords: TAPP
TEP
Lichtenstein
syntethic mesh
hernioplasty
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: Jagiellonian University
name: Holy Jan Grande Boni Fratres Hospital in Krakow
name: Stefan Zeromski Hospital in Kraków
First posted: 2016-10-10
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post-operative complications associated with wound
timeFrame: 30 days after surgery
Secondary outcomes:
measure: The frequency of conversions (from laparoscopic to open approach)
timeFrame: 1 year
Other outcomes:
measure: Evaluation of the severity of pain according to VAS (visual analogue scale)
timeFrame: 1 year after surgery
measure: Quality of life.
timeFrame: Prior to surgery, 1 and 6 months after the operation using SF-36 questionnaire.
Locations:
Study officials:
affiliation: Department of Experimental and Clinical Surgery, Jagiellonian University Medical College
name: Miroslaw Szura, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Experimental and Clinical Surgery, Jagiellonian University Medical College
name: Rafal Solecki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anatomy, Jagiellonian University Medical College
name: Artur Pasternak, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stefan Zeromski Hospital in Krakow
name: Jakub Łomnicki, MD
role: PRINCIPAL_INVESTIGATOR
References: