PIVL repair for lateralised incisional hernia

• Research type

  Research Study

• Full title

  A prospective cohort study of the safety and efficacy of lateralised incisional hernia (including parastomal hernia) repair with a pedicled, innervated vastus lateralis (PIVL) flap.

• IRAS ID

  219747

• Contact name

  Parviz Sadigh

• Contact email

  Parviz.Sadigh@bartshealth.nhs.uk

• Sponsor organisation

  Queen Mary University of London

• Research summary

  A hernia occurs when an internal body part (e.g. bowel) pushes through a weakness in a muscle or surrounding tissue wall (e.g. abdominal wall). The ideal treatment of large incisional hernia (hernias which protrude through a healed surgical incision or around a stoma) is unknown and remains an important surgical challenge. Current repairs generally rely on the use of synthetic mesh with associated problems of infection and cost. We are not sure of the best way to treat these types of hernias but an ideal repair would:
  (a) Avoid foreign body implantation (e.g. synthetic mesh)
  (b) Provide ample new tissue to fill the defect (the hole in the abdominal wall muscle).
  (c) Be dynamic i.e. contract in response to rising abdominal pressure.
  An established surgical technique known as pedicled, innervated vastus lateralis (PIVL) flap has been used for the first time to treat large incisional flank (side of the abdomen) hernias. A PIVL is a piece of muscle taken from your thigh. This piece of muscle is taken with its blood and nerve supply intact and inserted over the defect in the abdominal wall muscle which is causing the hernia.
  Research Question
  Can pedicled innervated, vastus lateralis muscle flap (PIVL)be used safely and effectively to repair large lateralised incisional hernia.
  Design
  Single-centre prospective pilot cohort study (a small group of participants at a single research site)
  Participants
  Purposefully, 10 patients with a large hernia surrounding their stoma and 10 patients with large incisional hernia (e.g. from a previous stoma site)
  Outcomes
  Safety outcomes will include surgical complications, recurrence of hernia, pain and quality of life scores recorded at up to 6 follow up appointments. A basic cost-benefit analysis will also be performed.
  Study Duration
  36 months (recruitment 12 months; follow-up 24 months).

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  17/LO/1143

• Date of REC Opinion

  12 Sep 2017

• REC opinion

  Further Information Favourable Opinion