NCT03564535

Comparison of Self Fixating Mesh to Mesh Fixation With Metallic Tacks in Laparoscopic Inguinal Hernia Repair

Comparison of Mesh Fixation With Tackers to Use of Self Fixating Mesh in Total Extra Peritoneal Inguinal Hernia Repair: A Double Blinded Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: All India Institute of Medical Sciences, Bhubaneswar · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study compares the use of self-fixating mesh to mesh fixation with tackers in the management of inguinal hernia by laparoscopic method. Half of the participants in the study will be treated using self-fixating mesh, while the other half will be treated using conventional mesh fixed with tackers.

Detailed description

Conventional tacker mesh fixation group Patients will be undergoing mesh fixation with non-absorbable tacks. Monofilament polyester mesh of size 15\*11cm will be used. The tacks would be used such that they avoid bony prominences and vascular and neural structures. One tack will put at the Cooper's ligament and another applied laterally superior to the iliopubic tract in the anterior abdominal wall. In any patient, the maximum number of tacks applied will not exceed four. Preperitoneal space will be deflated under direct visualization after the mesh is placed. Hernia sac and any cord lipoma will be placed behind the mesh. During the deflation process, repositioning of the peritoneal sac on the mesh, in particular the dorsal edge of the latter would be carefully performed to avoid displacement or folding of the mesh. Self-fixating mesh group In this group,Monofilament polyester mesh with polylactic acid (PLA) microgrips of size 15\*11 will be used. It is an isoelastic large-pore knitted fabric with a density of 73g/m2 at implantation and 38g/m2 after microgrips absorption which will be at 18 months. The resorbable micro grips provide immediate adherence to surrounding muscle and adipose tissue during the initial days post hernia surgery, serving as an alternate method of fixation to traditional sutures, tacks, staples, or fibrin sealants. No additional tacks, staples, sutures, or fibrin sealant is used

Conditions

• Inguinal Hernia
• Adult

Interventions

Type	Name	Description
DEVICE	Self fixating group	Monofilament polyester mesh with polylactic acid (PLA) microgrips of size 11\*15 will be used. It is an isoelastic large-pore knitted fabric with a density of 73g/m2 at implantation and 38g/m2 after microgrips absorption which will be at 18 months. The resorbable micro grips provide immediate adherence to surrounding muscle and adipose tissue during the initial days post hernia surgery, serving as an alternate method of fixation to traditional sutures, tacks, staples, or fibrin sealants. No additional tacks, staples, sutures, or fibrin sealant will be used.
DEVICE	Tacker fixation group	Patients will be undergoing polyester mesh fixation with non-absorbable tacks. The tacks would be used such that they avoid bony prominences and vascular and neural structures. One or two tacks will be put at the Cooper's ligament and another applied laterally superior to the iliopubic tract in the anterior abdominal wall. In any patient, the maximum number of tacks applied will not exceed three.

Timeline

• Start date: 2018-04-18
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2018-06-21
• Last updated: 2021-02-03

Locations

1 site across 1 country: India