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

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ClinicalTrials.gov Identifier: NCT03434301
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Incisional Hernia Hernia Abdominal Hernia Device: ReliaTack™ Device: Protack™ Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™ (TACKoMesh Study)
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : December 21, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Mesh with absorbable tack fixation
Mesh with absorbable tack (ReliaTack™) fixation
Device: ReliaTack™
Absorbable tack (ReliaTack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.

Active Comparator: Mesh with non-absorbable fixation
Mesh with non-absorbable (Protack™) fixation
Device: Protack™
Non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.




Primary Outcome Measures :
  1. Pain score [ Time Frame: 30 days ]
    Pain Score at rest and activity at day 30 recorded using visual analogue pain score (VAS) (0-10cm).


Secondary Outcome Measures :
  1. Visual analogue pain score (VAS). [ Time Frame: Day 1, days 5-7, 3 months, 1 year. ]
    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.

  2. Seroma formation. [ Time Frame: Days 1, 6, 30, 3 months and 1 year post-operation. ]
    Seroma formation (no fixed time point) (a seroma will be defined as any clinically apparent fluid collection at the site of mesh placement).

  3. Postoperative hospital stay. [ Time Frame: Time from end of Surgery to patient discharge (up to end of study; 104 weeks). ]
    The length of postoperative hospital stay.

  4. Time to return to normal daily activity. [ Time Frame: From day of surgery to end of study (104 weeks). ]
    The time to return to normal daily activity.

  5. Wound infection. [ Time Frame: Days 1, 6, 30, 3 months and 1 year post-operation. ]
    Any wound infection.

  6. Operating time. [ Time Frame: Length of Operation. ]
    The time taken for the Operation - from start to finish.

  7. Mesh fixation time. [ Time Frame: Time during Operation. ]
    Mesh fixation time after adhesions have been taken down and fascia closed.

  8. Hernia recurrence. [ Time Frame: Days 1, 6, 30, 3 months and 1 year post-operation. ]
    Hernia recurrence at one year and at all time points.

  9. Health-related quality of life. [ Time Frame: 30 days and 1 year post-operation. ]
    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).

  10. Adverse Events. [ Time Frame: Days 1, 6, 30, 3 months and 1 year post-operation. ]
    To capture any Adverse Events during the study duration.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434301


Contacts
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Contact: Emily Weaver 0161 701 8558 ext 18558 Emily.Weaver@mft.nhs.uk
Contact: Nicola Marpole 0161 701 6671 ext 16671 Nicola.Marpole@mft.nhs.uk

Locations
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United Kingdom
Manchester University NHS Foundation Trust Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Emily Weaver    0161 701 8558 ext 18558    Emily.Weaver@mft.nhs.uk   
Principal Investigator: Aali J Sheen, MD, FRCS         
Sponsors and Collaborators
Manchester University NHS Foundation Trust
Medtronic
Investigators
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Principal Investigator: Aali J Sheen Manchester University NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03434301    
Other Study ID Numbers: R04484
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manchester University NHS Foundation Trust:
Surgery
Laparotomy
Tack
Non-absorbable Tack
Absorbable Tack
Pain
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes