Use of Human Fibrin Glue Versus Staples for Mesh Fixation in Laparoscopic Transabdominal Preperitoneal Hernioplasty
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Inguinal hernia repairs belong to the most common surgical procedures worldwide. Increasingly
      they are performed using endoscopical techniques (laparoscopy). Many surgeons prefer to cover
      the hernia gap with a mesh to prevent recurrence. For it, the mesh must be fixed tightly, but
      tension free. During laparoscopic surgery the mesh is fixed commonly with staples or tissue
      glue. However, it is not uncommon that staples cause pain at the staple sites while moving.
      In addition, staples can cause scarring of the abdominal wall leading to chronic pain.

      Aim of the study is to provide evidence that mesh fixation with tissue glue causes less
      postoperative pain compared to fixation with staples.

      Patients with unilateral inguinal hernia will be randomized to receive either mesh fixation
      with tissue glue or staples (ratio 1:1).

      Patients with bilateral inguinal hernia will receive mesh fixation with tissue glue on one
      side and staple fixation on the other side. The side treated with tissue glue will be
      randomized (ratio 1:1).
    

Detailed description: 
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      The inguinal hernia is the most common hernia, including 90% of all spontaneous hernias, and
      the inguinal hernia repair is the most frequently performed procedure in general surgery. In
      the United States more than 700,000 inguinal hernias are repaired annually and in Germany
      more than 200,000. The standard method for inguinal hernia repair, originally described by
      Bassini in 1889, is the closure of the inguinal canal using sutures. Due to the high
      recurrence rate of this technique, methods using the tension-free implantation of synthetic
      meshes were established. Furthermore, endoscopic/laparoscopy methods were established, in
      which the hernia canal is usually approached from the posterior side opposite to the anterior
      site in the open approach. It is still hotly debated which of these approaches and methods is
      the best. Among the various posterior techniques using preperitoneal mesh implantation, the
      transabdominal preperitoneal patch plastic repair (TAPP) and the total extraperitoneal (TEP)
      repair achieved the highest acceptance. There are many indications for the use of both
      techniques, but the TAPP is recommended especially for recurrent hernias (after open
      preperitoneal patch plastic) and difficult hernias (sliding or incarcerated hernias). The
      advantages of the TAPP are that it is easier to perform, has a better possibility of
      standardization, and offers the option to perform a diagnostic laparoscopy. Thus, the type of
      hernia can be assessed immediately on both sides and a bilateral repair can be performed
      without additional incisions. In general, learning TAPP is easier than TEP. Most randomized
      studies comparing laparoscopic with open repair found the following results for laparoscopy:
      reduced postoperative pain, earlier return to work, increased costs, increased operating
      time, longer learning period, and during the early learning phase an increased recurrence and
      complication rate. In summary open, mesh-based, tension-free repair remains the standard, but
      laparoscopic herniorrhaphy, in the hands of adequately trained surgeons, produces excellent
      results comparable to those of open repair.

      Whether patients suffer from postoperative pain depends on many factors like the type of
      intervention, complications, age, and individual tolerance. In particular the type of mesh
      fixation employed during hernioplasty has a strong influence on postoperative pain. In a
      recent review mesh fixation by glue was compared to mesh fixation with staplers during
      endoscopic inguinal hernia repair (Surg Laparosc Endosc Percutan Tech (2010) 20:205). For the
      transabdominal preperitoneal patch plastic repair two randomized controlled trials, one non
      randomized trial and two case series were identified in this review. Although the authors
      found reduced postoperative pain and faster recovery after glue fixation without any
      significant difference in the recurrence rate, the authors still concluded: "As the overall
      quality of published data remains poor, further well-designed studies are needed until fibrin
      sealing can replace mechanical stapling as a new standard for mesh fixation." Thus well
      designed randomized studies comparing glue vs. staples fixation during TAPP are still
      warranted. Most of the previous studies applied only one mesh fixation method for patients
      with bilateral hernias. Only one study compared glue and stapler fixation in single patients
      with bilateral hernias. In this study a 2x2 design will be used, to compare the two fixation
      methods in patients with unilateral hernia as well as to compare the two methods in the same
      patient with bilateral hernias, eliminating the interindividual bias of the single hernia
      group. Furthermore this study focuses on the early postoperative pain, with a rather thorough
      coverage in the first 2 days. In many other studies the first time pain is measured is one
      month after surgery, which is the last time point in this study.

      The main aim of this trial is to investigate the early postoperative pain after laparoscopic
      hernia repair in TAPP technique using either fibrin glue or staples for mesh fixation.
    

Intervention name(s): Tissue glue; Staples
Intervention type(s): Drug; Device
Intervention description(s): The mesh fixation for the transabdominal preperitoneal patch plastic repair will be performed with 2 mL of tissue glue.; The mesh fixation for the transabdominal preperitoneal patch plastic repair will be performed with ProTack (Covidien) and Securestrap (Ethicon) staples.
Other intervention name(s): Tisseel (Baxter); ProTack (Covidien); Securestrap (Ethicon)
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hernia, Inguinal