Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair

Pain, Acute Clinical Trial

Official title: Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair; Prospective Randomized Double-blinded Controlled Study

Status Completed

Clinical Trial Summary

Inguinal hernias are one of the most common diseases in general surgery practice. In a multicenter study conducted in Germany, inguinal hernia repair is one of the most common operations. Until the last 20 years, after Lichtenstein described tension-free mesh hernia repair, this method was the gold standard in inguinal hernia surgery. This method was advantageous in terms of both less recurrence and less postoperative pain compared to tension methods. With the development of minimally invasive surgery, laparoscopic hernia surgery was first described by Dr. Ger in 1992. Laparoscopic inguinal hernia repair is based on the principles of preperitoneal repair described by Stoppa in open surgery. Its advantages over laparoscopic surgery are; Less post-operative pain, rapid recovery, reduction in nerve damage and chronic pain, and reduced recurrence rate. However, the disadvantage is that the learning curve is longer and higher cost. Two commonly used laparoscopic inguinal hernia surgeries are Trans Abdominal Pre-Peritoneal (TAPP) and totally extraperitoneal (TEP) methods. Although both are preperitoneal repair methods, less intraperitoneal organ damage, less intra-abdominal adhesion formation, and no need for peritoneal sheath repair are the advantages of the TEP method. For this reason, TEP method has been the preferred method today. Various methods have been tried in order not to change the location of the mesh placed in the TEP method. Laparoscopic inguinal hernia is one of the most debated issues. The most common methods for fixation are tacker, tissue adhesive, or suturing the mesh. However, fixing the mesh using a tacker can cause chronic pain. Tissue adhesives are not preferred because tissue adhesives have high costs and sometimes cause allergic reactions. The method in which the mesh is sewn to the pubic bone is avoided by surgeons because it prolongs the operation time. To avoid chronic pain after surgery, the idea was not to fix the mesh. The major drawback of this method is that the mesh may slip and cause recurrence.This study aimed to reveal the difference between the amount of migration and the amount of post-operative pain between detecting the mesh and not detecting it

Clinical Trial Description

The study will be conducted as a prospective, double-blind, randomized controlled study in the general surgery clinic of a university hospital. As a result of the power analysis calculated under Cohen's expert opinion, it was decided to include a total of 100 patients, 50 patients in order to reach 80% power with 0.50 effect size (medium effect) and 5% error (alpha=0.05). in each group. The study will continue by taking the consent of the patients and choosing from among the volunteer patients. The method by which the patients will be operated will be determined by choosing from a total of 100 (50 per group) sealed envelopes containing the group names. In the first (Fixation Group) group, inguinal hernia repair with the TEP method will be fixed with a mesh stapler. While inguinal hernia repair is performed with TEP method in the second (Non-Fixation Group) group, the mesh will not be fixed by any method. Exclusion criteria; It was determined as being younger than 18 years of age, having a comorbidity that prevented him from receiving general anesthesia, having had a previous lower abdominal surgery, having undergone previous inguinal hernia surgery, having bilateral inguinal hernia, scrotal hernia or strangulated hernia.

Creation of double blind; Patients will not be told which study group participants are in as a result of the envelope participants choose. In the postoperative follow-up of the patients, the researcher who recorded the parameters related to the study and provided the measurements will not know which group the patients are in.

Age, gender, comorbidity, smoking history and body mass index of the patients will be recorded on the preoperative forms. The surgery will be performed by a single surgeon according to the group chosen by the patients. The performing surgeon was a general surgeon with 5 years of active experience in laparoscopic hernia surgery and had performed both methods more than 200 times. Until the end of the study, only the surgeon will know which group the patients are in. The investigator evaluating the results of the study and the performing surgeon will not communicate about the study. ;

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Acute
• Pain, Chronic

• NCT number: NCT05152654
• Study type: Interventional
• Source: Hitit University
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Completion date: August 31, 2021