Is sacral nerve stimulation effective following anterior resection?
Research type
Research Study
Full title
Is sacral nerve stimulation effective in the treatment of faecal incontinence following low anterior resection for rectal cancer?
IRAS ID
148142
Contact name
Emile Tan
Contact email
Sponsor organisation
Chelsea & Westminster Hospital
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
Rectal cancer treatment involves a combination of surgery, radiotherapy and chemotherapy and often has a long-term adverse effect on how the bowel works, with ~50% of patients experiencing symptoms such as looser, more frequent stools, needing to rush to the lavatory and faecal incontinence. This is known as low anterior resection syndrome, LARS. We want to see if stimulating the nerves involved in control of the back passage can help improve these symptoms. This treatment is known as sacral nerve stimulation (SNS), and is already proven effective is already used in the treatment of faecal incontinence from other causes. We will do this by comparing SNS (device ON) to a placebo (device OFF)
Participants will complete questionnaires regarding bowel function and quality of life in addition to undergoing a physical examination. Next, an electrode is inserted into the lower back close to the nerves that control bowel function. This is connected to an external device which allows us to stimulate the electrode. Patients will undergo this trial test for 3 weeks, keeping a diary of their bowel function. If they show a >50% improvement in symptoms, then they will be eligible to proceed to the next part of the trial.Remaining participants are randomised into two groups, before undergoing a small operation to place a pulse generator in the buttock region, which is connected to the already placed electrode. Devices will either be switched ON or OFF for a period of 12 weeks. Participants will not know whether their device is on or off. Following a 4 week washout phase (to minimise residual effect from prior stimulation), patients undergo another 12 week period where their device is switched either ON or OFF.
All participants will have their devices switched on trial completion and will revert to standard NHS care.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0278
Date of REC Opinion
23 Jul 2015
REC opinion
Further Information Favourable Opinion