Inguinal Hernia
Conditions
Keywords
TAPP, TEP, Lichtenstein, syntethic mesh, hernioplasty
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.
Interventions
PROCEDUREHernia Repair
Sponsors
Jagiellonian University
Holy Jan Grande Boni Fratres Hospital in Krakow
Stefan Zeromski Hospital in Kraków
Miroslaw Szura
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| The frequency of conversions (from laparoscopic to open approach) | 1 year |
Other
| 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. |
Contacts
Primary ContactMiroslaw Szura, MD, PhD
Backup ContactArtur Pasternak, MD, PhD
Outcome results
None listed