MedTrace Logo

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

NCT03564535 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2021-02-03

No results posted yet for this study

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.

Conditions

  • Inguinal Hernia
  • Adult

Interventions

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.

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Bhubaneswar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03564535 on ClinicalTrials.gov