Efficacy and acceptability of a Renew anal insert

• Research type

  Research Study

• Full title

  Study Protocol: Efficacy and acceptability of a Renew anal insert in patients who have undergone restorative proctocolectomy with ileal pouch anal anastomosis.

• IRAS ID

  211493

• Contact name

  Jonathan Segal

• Contact email

  jonathansegal1@nhs.net

• Sponsor organisation

  Alan Warnes

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Treating anal incontinence in patients remains challenging. It has significant social and economic implications and can significantly affect a patient’s quality of life(1–3). It is likely that prevalence of faecal incontinence is underestimated due to patients reluctance to report it(4).

  Restorative proctocolectomy (RPC) with ileal pouch anal anastomosis (IPAA) was pioneered by Parks and Nicholls in 1978 (5).It is an operation that removes a patients diseased whole colon and uses the patients own remaining small bowel to create a reservoir for stools to sit it it.The advantage of this operation is it removes the need for a long term stoma (often referred as a bag). It is an operation that gained acceptance in the surgical management of medically refractive ulcerative colitis, an inflammatory bowel condition and cancer prevention in familial adenomatous polyposis (FAP) whose colons are predisposed to multiple polyps that in time can become cancerous.
  Incontinence following RPC and IPAA has not been widely researched. In one study at 10 year follow up, continence for stool and gas was present in 79.3% of patients, with 74.4% fully continent overnight. Incontinence following RPC with IPAA can be multifactorial and be related to inflammation of the pouch (pouchitis), inflammation of the cuff (cuffitis) collections, muscle and sphincter weakness and other post-operative complications. Despite attempting to treat the underlying cause, incontinence may still remain a problem and symptomatic control may be necessary.

  the aims of the study is to determine if the Renew anal insert is acceptable and efficacious in controlling and improving incontinence in patients with a RPC and ileoanal pouch anastomosis.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  16/LO/1441

• Date of REC Opinion

  20 Sep 2016

• REC opinion

  Further Information Favourable Opinion