Abstract
Aim
Provide a report on all patients who underwent laparoscopic incisional hernia repair as part of the TACKoMesh RCT prior to unblinding of treatment arms.
Material and Methods
Trial recruitment was for primary incisional hernia with a defect diameter of 3–10cm. 63 patients (target 74-136) were operated on prior to the outbreak of COVID-19. Post-operative pain is the primary trial outcome.
Surgery was performed with either spiral-tack mesh-fixation device (Protack (permanent) or Reliatack (absorbable)), Symbotex IPOM mesh, and fascial closure with no 1 Maxon suture(s) using extracorporeal knot ties – the Manchester Technique.
Data was collected on trial forms and lifestyle questionnaires (SF-36 and CCS). All data were explored and described in RStudio v1.4.1106.
Results
Patients were aged 36-80 and 36(57.1%) patients were male. Mean preoperative BMI was 30.91(sd5.11,range21.15–43.93).
Mean operating time was 80.81(37.34,20-240)minutes. In 13(20.6%) patients multiple hernia defects were identified. A good degree of fascial closure was achieved in all patients using a median of 3(IQR 2.0-3.5)knots.
Median mesh-fixation time was 286(159.5-428.0)seconds and a mean 25.24(5.49,14-41)tacks/patient were used. Median length of hospital stay was 3.5(2.0–6.0)days.
Patients were asked “Please indicate on this scale [VAS 0–10] the pain that you currently experience from your incisional hernia during activity?”. Median responses for Day0/pre-op, Day1, Day6, Day30 and Day365 were 4.5, 8.0, 6.0, 3.0 and 1.5 respectively.
At one year, 7(11%) patients had experienced hernia recurrence and 33(52%) post-operative seroma.
Conclusions
Target recruitment was not possible owing to COVID-19. The Manchester Technique has comparable recurrence rates. Reported pain increases post-operatively but is reduced at post-operative day30 and day365.
Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: a randomized trial of three fixation techniques
