Comparison of Self Fixating Mesh to Mesh Fixation With Metallic Tacks in Laparoscopic Inguinal Hernia Repair
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Adult
- Inguinal Hernia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients of uncomplicated inguinal hernia presenting to the outpatient department of AIIMS, Bhubaneswar will be recruited to the study. They would be put either in the conventional tacker group or self-fixating mesh group based on the sealed envelope which will be revealed once the patient is intubated. Random allocation done using random allocation software. Surgeries would be performed by single surgery team experienced in laparoscopic hernia repair.Masking: Double (Participant, Outcomes Assessor)Masking Description: Both patients and follow-up clinician will be blinded regarding the use of mesh fixation. The mesh fixation technique will only be entered in the master chart of the student but not in the Operation notes, in order to prevent accidental disclosure by a curious patient or follow up evaluator instead the phrase, "TEP done by 11x15cm mesh will be written.'' For legal reasons details of the tack applicator device will be recorded on the nursing count sheet.) Follow-up will be performed by a different clinician to the operating surgeon. There would be no external clues such as differences in the location or size of skin incisions to indicate whether fixation had been performed or not.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
Conventional tacker mesh fixation group Patients will be undergoing mesh ?xation 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 li...
Conventional tacker mesh fixation group Patients will be undergoing mesh ?xation 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 de?ated under direct visualization after the mesh is placed. Hernia sac and any cord lipoma will be placed behind the mesh. During the de?ation 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
Tracking Information
- NCT #
- NCT03564535
- Collaborators
- Not Provided
- Investigators
- Not Provided
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