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

Study Overview
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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.

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

Official Title
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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

Conditions
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Inguinal Hernia, Adult

Intervention / Treatment
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* Device: Self fixating group
* Device: Tacker fixation group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral inguinal hernia Age 18-80years American Society of Anesthesiologists (ASA) Grade 1 or 2 Exclusion Criteria: Patient unfit for general anesthesia or laparoscopic surgery Large scrotal hernias Irreducible hernias Morbid obesity Previous pelvic surgery Coagulopathy Those who cannot understand the VAS score Those who did not agree to participate in the study Gastritis Gastroesophageal reflux disease Liver dysfunction kidney dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SELF FIXATING GROUP<br>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: Self fixating group<br>* 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.<br>* Other names: Monofilament polyester mesh with polylactic acid microgrips;|
| Active Comparator: TACKER FIXATION GROUP<br>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. | Device: Tacker fixation group<br>* 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.<br>* Other names: Polyester mesh with tack fixation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in post operative pain | Postoperative pain will be evaluated using Visual Analogue Scale (0 TO 10) at follow up at ward, Out Patient Department/patient's pain diary/by telephonic call/by e-mail. In the first 6hours, if the VAS score >4 Inj.Paracetamol 1gm I V will be given, if the VAS score >4 after 30min of previous dose, inj diclofenac 75mg iv will be given, if VAS score is still >4 inj.Tramadol 100mg will be given. After 6 hours pain killers will be given in the same order and same dose orally as a tablet depending upon the requirement and pain score. Highest pain score at any given point of time and average pain score will be calculated. | 1 hour, 6 hours,12 hours, 24 hours, 7 days, 1 month and 3 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesh displacement | Meshes will be marked with three 5-mm surgical clips at its medial inferior, medial superior and lateral inferior corners. Pelvic x ray will be done on post operative day 1 and at the end of 1 month to look for any displacement. | 24 hours and 1 month post surgery | 
| Inflammatory markers | On the day of surgery, preoperative venous blood samples (baseline) will be withdrawn and assayed for C-reactive protein (CRP) levels, erythrocyte sedimentation rate (ESR), and total white blood cell count (WBC). Venous blood samples will be obtained 48 h post-surgery and assayed for CRP and WBC. ESR will be checked at 3 months postoperatively. Acute surgical trauma corresponding to postoperative acute pain will be measured using CRP and WBC, while chronic pain will be measured with ESR. | On the day of surgery (pre op), 48 hours post surgery, 3 months post surgery | 
| Post operative complications | Various known post operative complications will be looked for such as Post-operative urinary retention Seroma Hematoma Early recurrence Wound infection Cord edema Testicular atrophy | 6 hours, 24 hours, 48 hours, 7 days, 1 month, 3 months post surgery | 
| Operative time | Time required to complete the surgery i.e from incision time to closure time. | Time of skin incision to time of skin closure | 
| Achieving criteria of fitness for discharge | Discharge criteria includes Pain adequately controlled by oral analgesics (VAS Score <4) Ambulation without help Absence of post operative complications requiring surgical interventions | Time of skin closure to time of discharge which will be approximately 2 days. | 
| Resumption to normal activities | Return to normal activity will be assessed by recording the time taken by the patient to get in and out of bed and ambulate without help. | Immediate post operative period. | 
| Total cost towards the mesh and its fixation | Total cost involved in the procedure would be measured in both the arms. | Immediate post operative period. | 
| Quality of life using Carolinas Comfort Scale | Quality of life will be measured using Carolinas Comfort Scale (CCS), a validated post hernia quality of life and pain assessment tool developed by physician and researchers from Carolina laparoscopic and advanced surgery programme (CLASP), to monitor quality of life in patients undergoing hernia repair. The CCS is a 23-item, Likert type questionnaire that measures, on a scale of 0 to 5, severity of pain, sensation and movement limitations from the mesh. Carolinas Comfort Scale questionnaire (maximum: 115 points) Sensation of mesh, pain and movement limitations need to be graded on a scale of 0 to 5 or as not applicable While laying down, While bending over, While sitting up, 4.While performing activities of daily living (getting out of bed, bathing, getting dressed), 5 When coughing or deep breathing, 6 When walking or standing, 7 When walking up or down stairs, 8 When exercising (other than work-related), Total CCS score: ……… | 6 hours, 24 hours, day 7 , 1 month and 3 month post surgery. | 
| Mesh deployment time | Total time required from insertion of mesh into trocar till complete deployment is done. Mesh deployment satisfaction rate will also be noted. | Time from insertion of mesh into trocar till complete deployment is done. | 
| Intra operative complications | Various intra operative complications will be recorded such as Bladder injury Vas Deferens injury Iliac vein injury Pneumoperitoneum Dropping down/Injury of inferior epigastric artery Bowel injury | Intra operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy/Methods, Postoperative pain, Recurrence, Randomized Controlled Trials, Double-Blind Method, Pain, Chronic pain, Seroma, Total extraperitoneal repair, Tacker, Mesh fixation, Self gripping, Adult, Inguinal hernia, Inflammatory, Surgical Mesh