Clinical trial NCT03564535: Comparison of Self Fixating Mesh to Mesh Fixation With Metallic Tacks in Laparoscopic Inguinal Hernia Repair
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Adult
Keywords: Adult
Inguinal hernia
Inflammatory
Surgical Mesh
Laparoscopy/Methods
Postoperative pain
Recurrence
Randomized Controlled Trials
Double-Blind Method
Pain
Chronic pain
Seroma
Total extraperitoneal repair
Tacker
Mesh fixation
Self gripping
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in post operative pain
timeFrame: 1 hour, 6 hours,12 hours, 24 hours, 7 days, 1 month and 3 months post surgery
Secondary outcomes:
measure: Mesh displacement
timeFrame: 24 hours and 1 month post surgery
measure: Inflammatory markers
timeFrame: On the day of surgery (pre op), 48 hours post surgery, 3 months post surgery
measure: Post operative complications
timeFrame: 6 hours, 24 hours, 48 hours, 7 days, 1 month, 3 months post surgery
measure: Operative time
timeFrame: Time of skin incision to time of skin closure
measure: Achieving criteria of fitness for discharge
timeFrame: Time of skin closure to time of discharge which will be approximately 2 days.
measure: Resumption to normal activities
timeFrame: Immediate post operative period.
measure: Total cost towards the mesh and its fixation
timeFrame: Immediate post operative period.
measure: Quality of life using Carolinas Comfort Scale
timeFrame: 6 hours, 24 hours, day 7 , 1 month and 3 month post surgery.
measure: Mesh deployment time
timeFrame: Time from insertion of mesh into trocar till complete deployment is done.
measure: Intra operative complications
timeFrame: Intra operatively
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: Tushar S Mishra
state: Odisha
Study officials:
References:
citation: Liew W, Wai YY, Kosai NR, Gendeh HS. Tackers versus glue mesh fixation: an objective assessment of postoperative acute and chronic pain using inflammatory markers. Hernia. 2017 Aug;21(4):549-554. doi: 10.1007/s10029-017-1611-1. Epub 2017 Apr 17.
citation: Buyukasik K, Ari A, Akce B, Tatar C, Segmen O, Bektas H. Comparison of mesh fixation and non-fixation in laparoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2017 Aug;21(4):543-548. doi: 10.1007/s10029-017-1590-2. Epub 2017 Feb 18.
citation: Garg P, Rajagopal M, Varghese V, Ismail M. Laparoscopic total extraperitoneal inguinal hernia repair with nonfixation of the mesh for 1,692 hernias. Surg Endosc. 2009 Jun;23(6):1241-5. doi: 10.1007/s00464-008-0137-0. Epub 2008 Sep 24.
citation: Bresnahan E, Bates A, Wu A, Reiner M, Jacob B. The use of self-gripping (Progrip) mesh during laparoscopic total extraperitoneal (TEP) inguinal hernia repair: a prospective feasibility and long-term outcomes study. Surg Endosc. 2015 Sep;29(9):2690-6. doi: 10.1007/s00464-014-3991-y. Epub 2014 Dec 18.
citation: Teng YJ, Pan SM, Liu YL, Yang KH, Zhang YC, Tian JH, Han JX. A meta-analysis of randomized controlled trials of fixation versus nonfixation of mesh in laparoscopic total extraperitoneal inguinal hernia repair. Surg Endosc. 2011 Sep;25(9):2849-58. doi: 10.1007/s00464-011-1668-3. Epub 2011 Apr 13.