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

All India Institute of Medical Sciences, Bhubaneswar

Status: Unknown

Conditions: Adult; Inguinal Hernia

Treatments: Device: Tacker fixation group; Device: Self fixating group

Study type: Interventional

Funder types: Other

Identifiers

NCT03564535

T/IM-NF/Surg/17/36

Details and patient eligibility

About

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.

Full 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

Enrollment: 112 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Unilateral inguinal hernia
2. Age 18-80years
3. American Society of Anesthesiologists (ASA) Grade 1 or 2

Exclusion criteria

1. Patient unfit for general anesthesia or laparoscopic surgery
2. Large scrotal hernias
3. Irreducible hernias
4. Morbid obesity
5. Previous pelvic surgery
6. Coagulopathy
7. Those who cannot understand the VAS score
8. Those who did not agree to participate in the study
9. Gastritis
10. Gastroesophageal reflux disease
11. Liver dysfunction
12. kidney dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

SELF FIXATING GROUP

Experimental group

Description:

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.

Treatment:

Device: Self fixating group

TACKER FIXATION GROUP

Active Comparator group

Description:

Patients will be undergoing 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.

Treatment:

Device: Tacker fixation group