Clinical trial NCT06412445: Self-Fixating Mesh Versus Mesh Fixation With Tissue Glue in Laparoscopic Inguinal Hernia Repair
Official title: Self-Fixating Mesh Versus Mesh Fixation With Tissue Glue in Laparoscopic Transabdominal Inguinal Hernia Repair: A Comparative Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Inguinal Hernia
Keywords: TAPP
Self-Fixating Mesh
Mesh Fixation
Tissue Glue
Laparoscopic Transabdominal Inguinal Hernia Repair
Inguinal Hernia Repair
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Unilateral direct or indirect inguinal hernia

Exclusion Criteria:

* Bilateral hernia.
* Femoral hernia.
* Inguinoscrotal hernia.
* Complicated inguinal hernias.
* Recurrent inguinal hernias.
* Morbid obesity.

Primary outcomes:
measure: Hernia recurrence
timeFrame: Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months
measure: Chronic pain
timeFrame: Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months
Secondary outcomes:
measure: Length of surgery
timeFrame: 1 to 3 hours
measure: Immediate postoperative pain
timeFrame: 1 to 3 days
measure: Vascular/visceral injury
timeFrame: 1 to 3 hours
measure: Haematoma/seroma development
timeFrame: 1 to 7 days
measure: Length of hospital stay
timeFrame: 1 to 7 days
measure: Urinary retention
timeFrame: 1 to 2 days
measure: Wound infection/mesh infection
timeFrame: 1 to 30 days
measure: Recovery time to normal activity
timeFrame: 1 to 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Helwan University Hospitals
Study officials:
References: