Outcomes of Mesh Fixation Versus Non Fixation in Laparoscopic TAPP Inguinal Hernia Repair
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      This work aims to study the outcomes of mesh fixation versus non-fixation of laparoscopic
      TAPP inguinal hernia repair as regards postoperative pain, recurrence, operative time, and
      other postoperative complications.
    

Detailed description: 
      This is a randomized controlled clinical trial that will be conducted on patients who will
      undergo laparoscopic TAPP inguinal hernia repair in the General Surgery Department. Adult
      patients of either gender, aged between 18 and 65 years, who had early diagnosed inguinal
      hernia (unilateral or bilateral) were included. We excluded patients with a recurrent hernia,
      inguinoscrotal hernia, complicated hernia (incarcerated or strangulated), known ascites or
      connective tissue disease, heart and kidney failure, and hypoalbuminemia.

      Surgery will be performed under general anaesthesia with endotracheal intubation. Patients
      will be placed in the Trendelenburg position with access to the abdominal cavity through the
      umbilical port; then, pneumoperitoneum is obtained at 15 mmHg. After pneumoperitoneum, a
      laparoscope will be inserted through the umbilical incision. The second and third holes will
      be made on the abdominal median line's left and right side at the umbilical level.

      When entering the abdominal cavity, the peritoneum will be cut open in a curved shape 3 cm to
      the superior margin of the defect. To avoid urinary bladder injury, the medial border of the
      incision won't cross the medial umbilical ligament. Special attention will be paid to avoid
      inferior epigastric artery injury while cutting open the peritoneum in the medial part.

      When the sac of the oblique hernia enters the internal ring, it will be isolated as much as
      possible. If there is a large lipoma outside the hernia sac will also be excised. Isolation
      of preperitoneal space will be accomplished to guarantee the mesh flattening with the medial
      border at the pubic symphysis, the lateral border at the psoas major and anterior superior
      iliac spine, superior border at least 3 cm above the conjoined tendon, medial inferior border
      3 cm below the pectineal ligament, and lateral inferior border to permit perietalization of
      the spermatic cord (6-8 cm isolation of the hernia sac and spermatic cord). The patient is
      tilted head-down position.

      For the mesh fixation group, the mesh will be fixed to the abdominal wall using suture,
      spiral tacks, whereas for the non-fixation group it will be left as it is and the operation
      will be concluded. A mesh measuring 15x10cm is placed in the preperitoneal space and fixed
      using limited numbers of tacks or suture. In some cases, based on body habitus, a slightly
      smaller mesh could be used. The peritoneum will be closed over the mesh to reduce the risk of
      mesh adhesion to intestines, erosion, fistula formation, and small bowel obstruction by one
      of three methods: suture, or tack closure.

      Operative data will be collected as regard operative time, the effect on chronic pain and
      quality of life, recurrence, and other complications (seroma, urine retention)
    

Intervention name(s): Laparoscopic TAPP inguinal hernia repair
Intervention type(s): Procedure
Intervention description(s): Isolation of preperitoneal space will be accomplished to guarantee the mesh flattening with the medial border at the pubic symphysis, the lateral border at the psoas major and anterior superior iliac spine, superior border at least 3 cm above the conjoined tendon, medial inferior border 3 cm below the pectineal ligament, and lateral inferior border to permit perietalization of the spermatic cord (6-8 cm isolation of the hernia sac and spermatic cord).
For the mesh fixation group, the mesh will be fixed to the abdominal wall using suture, spiral tacks, whereas for the non-fixation group it will be left as it is and the operation will be concluded. A mesh measuring 15x10cm is placed in the preperitoneal space and fixed using limited numbers of tacks or suture. In some cases, based on body habitus, a slightly smaller mesh could be used. The peritoneum will be closed over the mesh.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment