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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Maura
Corsetti
+44 (0)115 9249924
maura.corsetti@nottingham.ac.uk
Dr
Alison
Lloyd
+44 (0)115 823 1589
researchsponsor@nuh.nhs.uk
Low anterior resection syndrome following rectal cancer treatment
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Rectal cancer is one of the most common cancers in the UK, and although chemo-radiotherapy and surgery are effective treatments, up to half of all patients report severe distressing problems after their treatment has finished. These include diarrhoea and problems with bowel control, ranging from needing to rush to the toilet (urgency), to complete bowel incontinence. This range of symptoms is known as “Low Anterior Resection Syndrome” (LARS) and can significantly affect quality of life. Unfortunately, at the moment, there are no effective treatments for LARS.
The symptoms of urgency and diarrhoea reported by LARS patients are similar to those in Irritable Bowel Syndrome (IBS). In IBS it has been shown that a cheap, widely available drug, called ondansetron. Ondansetron is normally used to treat nausea and vomiting and is effective and safe in treating diarrhoea and urgency.
The aim of this study is to find out if ondansetron helps resolve LARS symptoms.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Clinical and radiological anastomotic leakage after rectal cancer surgery, defined as a defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments2. Gastrectomy 3. Other known organic GI diseases (e.g. Crohn’s disease, ulcerative colitis, coeliac disease) 4. Untreated thyroid dysfunction 5. Taking other medications influencing colonic motility (e.g. opioids, cholinergic agents, prokinetics, metoclopramide, cisapride, etc.) which are likely to be stopped or changed during the course of the trial6. Lactose intolerance7. Known QTc interval ≥450 ms for men and ≥470 ms for women 8. Continuous use of ondansetron for >1 month within the past year9. Contraindications to ondansetron (e.g. concomitant use with apomorphine, hypersensitivity to any component of the preparation, rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption)10. Currently participating in any interventional phase of another clinical trial11. Pregnant or breastfeeding
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Maura
Corsetti
+44 (0)115 9249924
maura.corsetti@nottingham.ac.uk
Dr
Alison
Lloyd
+44 (0)115 823 1589
researchsponsor@nuh.nhs.uk
The study is sponsored by Nottingham University Hospitals NHS Trust and funded by National Institute for Health Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 44460
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
