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

Not Applicable

• Conditions: Adult; Inguinal Hernia
• Interventions: Device: Self fixating group; Device: Tacker fixation group

• Registration Number: NCT03564535
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

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

Study Timeline

• Study First Submitted: 2018-04-10
• Study Start: 2018-04-18
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-21
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SELF FIXATING GROUP	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	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.

Primary Outcome Measures

Name	Time	Method
Change in post operative pain	1 hour, 6 hours,12 hours, 24 hours, 7 days, 1 month and 3 months post surgery	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.

Secondary Outcome Measures

Name	Time	Method
Resumption to normal activities	Immediate post operative period.	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.
Achieving criteria of fitness for discharge	Time of skin closure to time of discharge which will be approximately 2 days.	Discharge criteria includes; 1. Pain adequately controlled by oral analgesics (VAS Score \<4); 2. Ambulation without help; 3. Absence of post operative complications requiring surgical interventions
Post operative complications	6 hours, 24 hours, 48 hours, 7 days, 1 month, 3 months post surgery	Various known post operative complications will be looked for such as; 1. Post-operative urinary retention; 2. Seroma; 3. Hematoma; 4. Early recurrence; 5. Wound infection; 6. Cord edema; 7. Testicular atrophy
Operative time	Time of skin incision to time of skin closure	Time required to complete the surgery i.e from incision time to closure time.
Intra operative complications	Intra operatively	Various intra operative complications will be recorded such as; 1. Bladder injury; 2. Vas Deferens injury; 3. Iliac vein injury; 4. Pneumoperitoneum; 5. Dropping down/Injury of inferior epigastric artery; 6. Bowel injury
Mesh displacement	24 hours and 1 month post surgery	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.
Inflammatory markers	On the day of surgery (pre op), 48 hours post surgery, 3 months post surgery	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.
Total cost towards the mesh and its fixation	Immediate post operative period.	Total cost involved in the procedure would be measured in both the arms.
Quality of life using Carolinas Comfort Scale	6 hours, 24 hours, day 7 , 1 month and 3 month post surgery.	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; 1. While laying down,; 2. While bending over,; 3. 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: .........
Mesh deployment time	Time from insertion of mesh into trocar till complete deployment is done.	Total time required from insertion of mesh into trocar till complete deployment is done. Mesh deployment satisfaction rate will also be noted.

Trial Locations

Locations (1)

Tushar S Mishra; 🇮🇳 Bhubaneswar, Odisha, India