Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412445
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-14
First Post:
2024-04-03
Brief Title:
Self-Fixating Mesh Versus Mesh Fixation With Tissue Glue in Laparoscopic Inguinal Hernia Repair
Sponsor:
Helwan University
Organization:
Helwan University
Study Overview
Official Title:
Self-Fixating Mesh Versus Mesh Fixation With Tissue Glue in Laparoscopic Transabdominal Inguinal Hernia Repair A Comparative Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 costbenefit 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
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 costbenefit 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None