PEVES V2
Research type
Research Study
Full title
Pilonidal Excision Vesus Endoscopic Surgery
IRAS ID
200374
Contact name
Raj Rajaganeshan
Contact email
Sponsor organisation
St Helens & Knowsley Teaching Hospitals NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Pilonidal disease is a common condition affecting the area at the base of back overlying the tailbone, the sacrococcygeal area. It commonly affects young men and is thought to be due to impacted hair leading to an inflamed area of skin. It can present as an acute abscess or as a chronic painful discharging area known as a sinus. The ideal treatment should promote healing of the area, minimise pain and scarring, and allow return to normal function and work in as minimal a time possible.
Excision of the affected area of skin is considered standard treatment, being well proven and accepted in current surgical practice. This technique is prone to wound breakdown, post operative pain, lengthy absence from work, as well as aesthetic concern due to scaring and deformity of the normal body contour. Many minimally invasive treatments have also been described in an attempt to minimise the risks of major surgery and the associated negative affects described above. This is whilst effectively treating the disease and have proven successful. Progression of these techniques has led to a new minimally invasive technique being developed. Endoscopic pilonidal sinus treatment (EPSiT) is a video assisted technique using special equipment (a fistuloscope) to allow direct vision to define affected areas, remove debris and clean tracts with electrocautery. It has been in use at Whiston Hospital for 2 years. This has proven initially successful, with reduced complication rate, reduced wound healing time, reduced absence from work, reduced length of stay, reduced post operative pain and reduced operative time compared to excision. However, there are no published randomised clinical trials.
Patients undergoing pilonidal sinus treatment who are entered into the trial will be randomly selected for treatment with EPSiT or excision. This will be done at the start of the trial prior to any surgical intervention.
REC name
London - Surrey Research Ethics Committee
REC reference
16/LO/0452
Date of REC Opinion
7 Mar 2016
REC opinion
Favourable Opinion