Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair
Condition: Inguinal Hernia; Pain, Acute; Pain, Chronic
MeSH terms: Hernia; Hernia, Inguinal; Acute Pain; Chronic Pain
Study type: Interventional

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
    

Detailed 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.
    

Intervention name(s): Tacker
Intervention type(s): Device
Intervention description(s): metallic staples used to fix the mesh
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients participating in the study will be divided into two groups. Patients with unilateral inguinal hernia will be determined according to the envelope selection method. Patients will not know which group are in. The patients in the first group will be fixed with 5 tackers while performing total extraperitoneal repair. While the patients in the second group are performing total extraperitoneal repair, no fixation will be made while placing the mesh.
Masking: Single (Care Provider)
Primary purpose: Treatment