Status:
COMPLETED
Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
Medtronic
Conditions:
Incisional Hernia
Hernia
Eligibility:
All Genders
18-80 years
Phase:
NA
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 t...
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 prospec...
Eligibility Criteria
Inclusion
- • All adults undergoing elective incisional hernia repair for midline abdominal incisional hernia, with a defect of 3-10cm in diameter.
Exclusion
- 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.
Key Trial Info
Start Date :
July 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2020
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03434301
Start Date
July 20 2017
End Date
September 22 2020
Last Update
December 7 2021
Active Locations (1)
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1
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL