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

Launched by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST · Feb 8, 2018

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility 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.

Trial Officials