Comparison of mesh fixation techniques in open ventral hernia repair

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: Adults with ventral hernias will be included in this study and they will undergo open ventral hernia repair with retromuscular placement of the mesh. The two techniques that will be applied will be either Rives‐Stoppa (for gaps with a transverse diameter of up to 5‐6 cm), or posterior separation of the abdominal wall elements with the transversus abdominis release technique (TAR) (for gaps with transverse diameter >5‐6 cm). In the field of inguinal hernias, studies have shown that the fixation method may have a difference concerning the postoperative pain and quality of life, when glue is used because theoretically it does not entrap nerves, or punctures vessels that could lead to hematoma. The aim of this study is to expand this observation to the retromuscular ventral hernia repair and find out if this difference applies in this case too. The patients will be randomized with a random number table into two groups based on the fixation method of the mesh (group A: suture, group B: glue). The type of sutures that will be used will be PDS and the glue will be cyanoacrylic, which is a biosynthetic material that is not as studied as the fibrin glue for this procedure. CONDITION: Retromuscular ventral hernia repair ; Surgery PRIMARY OUTCOME: Postoperative pain measured using the visual analogue scale of pain 0‐10 at 3 and 6 months SECONDARY OUTCOME: ; 1. Postoperative pain measured using the visual analogue scale of pain 0‐10 at 7, 14, 30 days and 12 months; 2. Hernia recurrence measured by clinical examination, CT scan if necessary at 7, 14, 30 days and 12 months; 3. Other complications measured by clinical examination, laboratory and radiological tests if necessary at 7, 14, 30 days and 12 months; 4. Duration of surgery in minutes, measured after the end of the operation; 5. Length of hospital stay in days, measured after the patient’s discharge; 6. The amount and the type of analgesic drugs needed at 7, 14, 30 days and 3, 6 and 12 months; 7. Quality of life measured using HerQLes and EuraHS QOL preoperatively and at 3, 6 and 12 months. These questionnaires assess the impact of abdominal hernia and surgery on rehabilitation, mental health, daily activities, work, exercise, pain, aesthetic outcome, and sex life.; INCLUSION CRITERIA: 1. Adults 2. Ventral hernia 3. Eligible for hernia repair
Epistemonikos ID: ea33fba65551f00af477a585f85ab099fdde7e6b
First added on: Aug 25, 2024