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

February 1, 2021 updated by: Tushar Subhadarshan Mishra, All India Institute of Medical Sciences, Bhubaneswar

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Odisha
      • Bhubaneswar, Odisha, India, 751019
        • Tushar S Mishra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Monofilament polyester mesh with polylactic acid microgrips
Active Comparator: 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.
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.
Other Names:
  • Polyester mesh with tack fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in post operative pain
Time Frame: 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.
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
Time Frame: 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.
24 hours and 1 month post surgery
Inflammatory markers
Time Frame: 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.
On the day of surgery (pre op), 48 hours post surgery, 3 months post surgery
Post operative complications
Time Frame: 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
6 hours, 24 hours, 48 hours, 7 days, 1 month, 3 months post surgery
Operative time
Time Frame: Time of skin incision to time of skin closure
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
Time Frame: 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
Time of skin closure to time of discharge which will be approximately 2 days.
Resumption to normal activities
Time Frame: 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.
Immediate post operative period.
Total cost towards the mesh and its fixation
Time Frame: Immediate post operative period.
Total cost involved in the procedure would be measured in both the arms.
Immediate post operative period.
Quality of life using Carolinas Comfort Scale
Time Frame: 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: ………
6 hours, 24 hours, day 7 , 1 month and 3 month post surgery.
Mesh deployment time
Time Frame: 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.
Time from insertion of mesh into trocar till complete deployment is done.
Intra operative complications
Time Frame: 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
Intra operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2018

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

June 15, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T/IM-NF/Surg/17/36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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