Cold therapy (HILOTHERM) in Adnexal surgeries

• Research type

  Research Study

• Full title

  Cold therapy (HILOTHERM) in Adnexal surgeries

• IRAS ID

  216078

• Contact name

  David Harding Verity

• Sponsor organisation

  Moorfields Eye Hospital NHS Foundation Trust

• Duration of Study in the UK

  0 years, 11 months, 31 days

• Research summary

  Research Summary -

  Tissue swelling and variable degrees of pain characterise the early healing phase in all patients undergoing surgery. The swelling in the soft tissue associated with the pain following eyelid surgeries prolongs the healing phase and delays a full functional recovery. Although pain typically resolves within a few days, the onset of inflammation and swelling may prolong pain for several days following surgery. Long recovery time after surgery can have a huge impact on patient’s quality of life as well as contribute to a long period of out of work while the patient recovers.
  
  Systemic anti inflammatories (such as steroids), treatment with cold packs, and pressure dressings have all been used to control swelling post surgery. Cold compress therapy has been a traditional approach to reduce swelling, although, until recently, no consistent method of applying such reduced temperature has ever been properly assessed. Typically, patients are asked to apply cold compresses in the form of ice packs to the area that was operated on, although the duration of application is limited by the discomfort caused by the temperature of the compress, typically around zero degrees Celsius . Furthermore, an extremely low temperature carries a risk of burns on the skin and therefore increasing the inflammation.
  
  The use of a constant controlled temperature cooling device, delivering sustained low temperature has recently been reported to reduce pain and swelling in patients undergoing facial and plastic surgery. This is an treatment option to improve the patient's discomfort after surgery and also potentially reduce a long surgical recovery time. So far the constant controlled cold temperature as an post operative therapy has only been used on facial and plastic surgery, with no existing data on its application in patients undergoing eyelids/tissue surrounding the eye surgeries. In this study we aim to use Hilotherm® (a device which gives constant controlled low temperature) to the area around the eye to test its effectiveness after eyelid surgeries.

  Lay Summary -

  Purpose Cooling therapy, applied during acute trauma, constricts blood vessels to lessen bleeding, bruising, and metabolic activity. It mitigates starvation of tissue of oxygen (hypoxia) and blood supply (Ischaemia), thereby reducing the inflammatory response that results in swelling and pain. It’s widely endorsed post-facial surgery. However, no scientific study has proven its value in occuloplastic and orbital surgery. We aim to investigate the effectiveness of controlled cooling therapy for patients undergoing orbital decompression surgery with the Hilotherm® cooling device.

  Methods
  We conducted a prospective study where we randomized patients undergoing symmetrical orbital surgery to have one side of their face cooled (15 degrees) for five days following surgery, while we used the opposite side as a control using a specialised cooling mask. A visual analogue scale (0-10) evaluated patient pain scores over the first week. We also asked patients a satisfaction question regarding their experience with the machine. We measured post-operative swelling using 3D scanning and measured the amount the eye protruded 1 week following the surgery.

  Results
  The study included 20 patients with thyroid eye disease, 16 of whom were female (80%), with an average age of 46 (range 20 – 71). Significant differences emerged in pain scores on Days 1-3 (p<0.05) with moderate effect sizes (Cohen's d of 0.30, 0.23, and 0.28, respectively), indicating a positive treatment effect. We observed no significant difference in pain scores from Day 4-7. No difference was found between proptosis reduction between the cooled and control sides 1 week after surgery. Eight participants (40%) reported noticeable difference in reduced swelling in the cooled side. Participants rated the device 2.9 out of 5 for comfort and 4.05 out of 5 for ease of use. Nine participants (45%) reported poor compliance after day 3 due to the device's discomfort.

  Conclusion
  Our data support cooling therapy during the first three days to reduce post-operative discomfort following orbital decompression surgery, with the most significant effect size noted on day 1. We may need further trials to evaluate cooling’s efficacy and its potential to reduce post-operative opioid use.
  

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  17/LO/0014

• Date of REC Opinion

  13 Jan 2017

• REC opinion

  Further Information Favourable Opinion