Self-Fixating Mesh Versus Mesh Fixation With Tissue Glue in Laparoscopic Inguinal Hernia Repair
- Conditions
- Inguinal Hernia
- Registration Number
- NCT06412445
- Lead Sponsor
- Helwan University
- Brief Summary
The main objective of this study is to compare between the safety and efficacy of self-fixating mesh versus mesh fixation with tissue glue in patients undergoing laparoscopic transabdominal inguinal hernia repair (TAPP). The criteria of comparison shall include operating time, post-operative pain and recurrence.
- Detailed Description
Inguinal hernia is the most common abdominal wall hernia. It is defined as a peritoneal sac protrusion through a weak point within the groin area. It often contains abdominal contents and is traditionally treated with surgery. Repair of inguinal hernia is one of the most commonly performed surgical procedures worldwide. Males are more commonly affected by inguinal hernia than females. The male to female ratio is approximately 9 to 1.
Whether to perform an open or a laparoscopic approach for inguinal hernia repair has always been a controversial issue. However, recent improvement in laparoscopic techniques has made it the procedure of choice in the opinion of most surgeons. Laparoscopic approach includes two main techniques, namely the total extra-peritoneal approach (TEP) and the trans abdominal pre-peritoneal approach (TAPP). However, TAPP has gained more popularity owing to its relative simplicity and easier reproducibility. TAPP involves standard laparoscopic approach with access into the peritoneal cavity and placement of a mesh along the anterior abdominal wall, thereby, repairing the hernia posterior to the defect.
During the repair of an inguinal hernia, sutures or tacks are generally used to secure the prosthetic mesh in place. In TAPP repairs, the peritoneum is closed using sutures or tacks. These mesh fixation or peritoneal closure techniques may contribute to postoperative chronic pain presumably due to nerve irritation or entrapment. Intraoperative strategies to reduce pain entail the use of non-mechanical methods of mesh fixation other than tacking or suturing, which may be less traumatic to the local tissue and less likely to cause local nerve entrapment. These non-mechanical methods include self-fixating meshes or glue. Similarly, closing the peritoneum with sutures may be less traumatic than the use of tacks, thus resulting in less postoperative pain.
By far, guidelines of the European Association for Endoscopic Surgery (EAES) and the European Hernia Society (EHS) reported no general evidence based consensus on the ideal tool for mesh fixation. Therefore, the choice often depends on surgeons personal preference, market availability and cost/benefit ratio. Recent advances in the biotechnology of mesh and mesh fixation industry lead to the production of innovative self-fixating meshes and alternatively meshes that are fixed with variable types of biomaterials and glue. Eventually, such tack free meshes are intended to reduce the rate of complications that might be attributed to tack bearing meshes. However, studies to evaluate the different tools of tack free mesh fixation techniques are still lacking.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Male
- Target Recruitment
- 50
- Unilateral direct or indirect inguinal hernia
- Bilateral hernia.
- Femoral hernia.
- Inguinoscrotal hernia.
- Complicated inguinal hernias.
- Recurrent inguinal hernias.
- Morbid obesity.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hernia recurrence Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months clinical or radiological at any time point
Chronic pain Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months pain persisting beyond three months postoperatively. Post-operative pain will be evaluated based on the numerical rating scale (NRS) 0-10, for pain self-reporting with reference to the patient's individual experience, where 0 indicates no pain, 1-3 mild pain, 4-6 moderate pain and 7-10 disabling severe pain
- Secondary Outcome Measures
Name Time Method Immediate postoperative pain 1 to 3 days Post-operative pain will be evaluated based on the numerical rating scale (NRS) 0-10, for pain self-reporting with reference to the patient's individual experience, where 0 indicates no pain, 1-3 mild pain, 4-6 moderate pain and 7-10 disabling severe pain
Urinary retention 1 to 2 days in immediate postoperative period
Recovery time to normal activity 1 to 7 days in days
Vascular/visceral injury 1 to 3 hours Any visualized or reported vascular or visceral injury during the operation
Length of surgery 1 to 3 hours in minutes
Haematoma/seroma development 1 to 7 days Haematoma or seroma development in postoperative period (Clinical or radiological)
Length of hospital stay 1 to 7 days in days
Wound infection/mesh infection 1 to 30 days at any time point
Trial Locations
- Locations (1)
Helwan University Hospitals
🇪🇬Cairo, Egypt
Helwan University Hospitals🇪🇬Cairo, Egypt