Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™

Study Overview
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Brief Summary
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This study is designed to examine the effects on post operative pain after the use of a fixation device to secure a mesh in the abdomen to repair a hernia of the abdominal wall. The fixation devices to be used differ with one being made from titanium and is permanent and the other being made from an absorbable material. Both fixation devices are commonly used but two questions remain unanswered, does one cause more chronic pain and also what if any will be the effect on recurrence rates of the hernia. No trial has been undertaken to date which will not only examine the fixation device but in the setting where the hernia is closed first. The closure of the hernial defect by the keyhole technique is a relatively new and growing concept in the hernia world.

Detailed Description
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TACKoMESH study (Comparison of using absorbable tacks (ReliaTack™) against a non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia) is a prospective, single-centre, double blinded randomised trial which aims to establish whether the use of absorbable (ABS) compared to non-absorbable (Non-ABS) tacks in adult patients undergoing elective incisional hernia repair produces a lower rate of pain both immediately and long-term. Secondary outcomes to be explored include seroma formation, hernia recurrence, length of postoperative hospital stay, wound infection, reoperation rate, operation time, health related quality of life and time to return to normal daily activity. Patients entering TACKoMesh will be randomised immediately prior to their operation with a 1:1 ratio of ABS versus Non-ABS tack arm allocation. The same composite mesh will be used for all operations. Follow-up is according to a predetermined schedule, using specifically designed Case Report Forms to collect the blinded data.

Official Title
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Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™ (TACKoMesh Study)

Conditions
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Hernia, Incisional Hernia, Abdominal Hernia

Intervention / Treatment
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* Device: ReliaTack™
* Device: Protack™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • All adults undergoing elective incisional hernia repair for midline abdominal incisional hernia, with a defect of 3-10cm in diameter. Exclusion Criteria: Patients less than 18 years of age, or unable to give informed consent. Patients over 80 years of age. Females of reproductive age. Prisoners. Clinically small incisional hernia <3cm maximum diameter. Emergency procedures (for irreducible, strangulated or obstructed hernia). Procedure involving dirty (purulent inflammation (e.g. abscess); preoperative perforation of respiratory, gastrointestinal, biliary or genitourinary tract; penetrating trauma >4 hours old) or contaminated (Non-purulent inflammation; gross spillage from gastrointestinal tract; entry into biliary or genitourinary tract in the presence of infected bile or urine; major break in technique; penetrating trauma <4 hours old; chronic open wounds to be grafted or covered) surgery. Patients with a Body Mass Index (BMI) >40 kg/m². Patients participating in any other study, whose concurrent participation in the TACK study might place them at undue risk or might confound the study data in the opinion of the chief investigators. Failure to close the anterior rectus sheath intraoperatively.

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesh with absorbable tack fixation<br>Mesh with absorbable tack (ReliaTack™) fixation | Device: ReliaTack™<br>* Absorbable tack (ReliaTack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.<br>|
| Active Comparator: Mesh with non-absorbable fixation<br>Mesh with non-absorbable (Protack™) fixation | Device: Protack™<br>* Non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain Score at rest and activity at day 30 recorded using visual analogue pain score (VAS) (0-10cm). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue pain score (VAS). | Visual analogue pain score (VAS) pain score at days 1, 5-7 3 months and 1 year post-operative. A preoperative VAS score will also be recorded. | Day 1, days 5-7, 3 months, 1 year. | 
| Seroma formation. | Seroma formation (no fixed time point) (a seroma will be defined as any clinically apparent fluid collection at the site of mesh placement). | Days 1, 6, 30, 3 months and 1 year post-operation. | 
| Postoperative hospital stay. | The length of postoperative hospital stay. | Time from end of Surgery to patient discharge (up to end of study; 104 weeks). | 
| Time to return to normal daily activity. | The time to return to normal daily activity. | From day of surgery to end of study (104 weeks). | 
| Wound infection. | Any wound infection. | Days 1, 6, 30, 3 months and 1 year post-operation. | 
| Operating time. | The time taken for the Operation - from start to finish. | Length of Operation. | 
| Mesh fixation time. | Mesh fixation time after adhesions have been taken down and fascia closed. | Time during Operation. | 
| Hernia recurrence. | Hernia recurrence at one year and at all time points. | Days 1, 6, 30, 3 months and 1 year post-operation. | 
| Health-related quality of life. | Health-related quality of life - assessed using the Carolinas Comfort Score™ (which is specifically designed for hernia repair) (26) and Short Form 36™, at pre-operatively, 30 days and 1 year, (appendix K and SF-36). | 30 days and 1 year post-operation. | 
| Adverse Events. | To capture any Adverse Events during the study duration. | Days 1, 6, 30, 3 months and 1 year post-operation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Laparotomy, Tack, Non-absorbable Tack, Absorbable Tack, Pain