Use of Human Fibrin Glue (Tisseel) Versus Staples for Mesh Fixation in Laparoscopic Transabdominal Preperitoneal Hernioplasty (TISTA)

TISTA

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).

2013-01-01

2014-12-01

2015-12-01

Completed

82

Inclusion Criteria: * primary hernia repair (no re-operation for recurrent hernia) * good compliance can be expected * informed consent Exclusion Criteria: * chronic pain * acute pain requiring analgesic others than paracetamol or more than a single dose non-steroidal anti-inflammatory drugs treatment within 48 h before surgery * current treatment with psychopharmaceutical drugs * mental incapacity * known incompatibility (allergies) with the Tisseel compounds

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 82, 'type': 'ACTUAL'}}

2023-08-08