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

Inguinal Hernia Clinical Trial

— SELFITAC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03564535
• Other study ID #: T/IM-NF/Surg/17/36
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 18, 2018
• Est. completion date: March 2021

Study information

• Verified date: February 2021
• Source: All India Institute of Medical Sciences, Bhubaneswar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult
• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

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.
• Tacker fixation group
Patients will be undergoing polyester mesh ?xation 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.

Locations

Country	Name	City	State
India	Tushar S Mishra	Bhubaneswar	Odisha

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, Bhubaneswar

Country where clinical trial is conducted

India, 

References & Publications (5)

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 — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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