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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2021-03-31

Brief Summary

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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.

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Detailed Description

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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

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Inguinal Hernia Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Self fixating group

Intervention Type DEVICE

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.

TACKER FIXATION GROUP

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.

Group Type ACTIVE_COMPARATOR

Tacker fixation group

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Monofilament polyester mesh with polylactic acid microgrips Polyester mesh with tack fixation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No