Comparison of mesh fixation techniques in elective laparoscopic repair

• Research type

  Research Study

• Full title

  Comparison of mesh fixation techniques in elective laparoscopic repair of incisional hernia – ReliaTackTM v ProTackTM TACKoMesh study

• IRAS ID

  213428

• Contact name

  Aali J Sheen

• Contact email

  aali.sheen@cmft.nhs.uk

• Sponsor organisation

  Central Manchester University Hospitals NHS Foundation Trust

• Duration of Study in the UK

  1 years, 10 months, 19 days

• Research summary

  Research 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 settting 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.

  Summary of Results
  No significant differences in reported pain ‘on activity’ were found at any timepoint. Less reported pain ‘at rest’ was found on post-operative day-1 with absorbable tacks (p=0.020). Significantly longer mesh-fixation time (p<0.001) and the use of more knots for fascial closure (p=0.006) and tacks for mesh-fixation (p=0.001) were found for the absorbable tack group.
  There were no differences in other clinical and PROMs between groups.
  For the whole trial cohort (n = 63) several domains in the Short-Form-36 showed a reduction from baseline scores at day 30 that improved at day 365. At post-operative day 30, 75.0% of patients reported ‘a lot of pain’ since discharge.
  

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  17/NW/0082

• Date of REC Opinion

  20 Mar 2017

• REC opinion

  Further Information Favourable Opinion