OC-086 COMPARISON OF MESH-FIXATION TECHNIQUES IN LAPAROSCOPIC REPAIR OF INCISIONAL HERNIA, RELIATACK™ V PROTACK™ (TACKOMESH) NCT 03434301

Autor: J Pilkington, F Wilkinson, J Pritchett, C Fullwood, A J Sheen
Rok vydání: 2022
Předmět:
Zdroj: British Journal of Surgery. 109
ISSN: 1365-2168
0007-1323
DOI: 10.1093/bjs/znac308.096
Popis: Background A study examining post-op pain, comparing permanent versus absorbable tack fixation devices, Protack™ versus Reliatack™, in IPOM plus repair. Methods TACKoMesh is a single-centre double-blind RCT conducted from 2017–2020 with 1-year follow up. Patients were randomised to either Protack™ (titanium tacks) or Reliatack™ (an articulating-arm with dissolvable tacks). Primary outcome was reported pain on activity at Day30. Secondary outcomes include recurrence and quality of life measures (SF-36 & Carolina Comfort Score). Results 67 patients randomised: 36 with Protack™, 27 with Reliatack™, with 4 conversions. No significant difference in reported pain ‘on activity’ (post-operative Day 1, 6, 30 and 365). There was significantly reduced pain ‘at rest’ on Day1 with Reliatack™ (Protack™ 6 [4 to 9] vs Reliatack™ 4 [3 to 5], p = 0.020) and reduced pain at all other points with Reliatack™. Operation (p = 0.001) & mesh-fixation (p = 0.001) times were longer, with more knots (p = 0.001) & tacks (p = 0.001) used with Reliatack™. Entire cohort hernia recurrence, seroma formation, SSI & Clavien-Dindo Grade III-V complication were 8/63 (12.7%), 33/63 (52.4%), 7/63 (11.1%), and 12/63 (19.1%) respectively. There were no significant differences in these outcomes between the treatment groups. CCS showed improvement from post-op Day30 to 365. SF36 showed a reduction in baseline scores at post-op Day30. Conclusion There is no difference in reported pain ‘on activity’ following elective IPOM plus hernia repair when choosing either Protack™ or Reliatack™. There is a trend towards improved post-op pain ‘at rest’ with Reliatack™.
Databáze: OpenAIRE