How many people suffer from bowel problems following surgery for colorectal cancer, and what treatments are the best for managing these problems?

There are two parts to the POLARiS Study. The POLARiS cohort and the POLARiS randomised control trial (RCT). The Cohort part of the POLARiS Study will ask people who have had an anterior resection for bowel cancer in the last 10 years about their quality of life and bowel symptoms every three months over a two-year period. It will take around 30 minutes to complete the full set of questionnaires at each timepoint. The cohort study aims to identify how many people are affected by LARS and to see how LARS impacts on their quality of life. It will also allow us to understand more about how LARS changes over time. At the time people join the cohort study, they might not know their LARS status. We expect nearly one in three, or one third (1/3), of the cohort study group will develop major LARS over their two-year study period. There will be no physical assessments for participants in the cohort except for at registration which could be done in-person. The POLARiS Study randomised controlled trial (RCT) part will include participants identified as having major LARS symptoms which have not been managed by previous or current treatment. The purpose of this part of the POLARiS study is to see how well the study treatment for LARS works and to determine if there is a ’best’ treatment overall. POLARiS is comparing sacral neuromodulation (SNM) and transanal irrigation (TAI) against optimised conservative management (OCM) for the treatment of major LARS. There are two primary comparisons for the randomised controlled trial - i) SNM versus OCM and ii) TAI versus OCM. Arm 1: Participants randomised to TAI will attend a one-hour practical education session with a specialist nurse where the device and volume will be decided. Potential devices: Aquaflush, Peristeen, Qufora IrriSedo Cone, Qufora IrriSedo Mini Irrigation fluid: body temperature water Duration & Frequency: 20-35min process every 24-48hrs post-randomisation for 24 months post-randomisation. Mode of administration: Self-administer at home. Adherence monitoring: clinical assessment at 3 months post-randomisation, then telephone assessments every 3 months until 12 months post-randomisation, then data collection from medical notes at 24 months post-randomisation. Arm 2: Participants randomised to SNM will have a consultation with their local clinician performing the SNM procedure. Sacral neuromodulation involves a minor surgical procedure under anaesthetic to insert a wire close to the sacral nerve, which is in the lower part of the back above the buttocks. The device works by improving the signaling between your muscles and your nerves to help with pelvic floor muscle strength and coordination. Potential devices: Axonics Neurostimulator, InterStim Neurostimulator Model 3058 Insertion procedure: Prior to being fitted with a permanent SNM device, a temporary wire is inserted. This will act as a test device to see if there is any improvement in symptoms over a 2-week period. If symptoms are improved with the temporary SNM device, participants will be offered to be fitted with a permanent device. This is usually done as a day case procedure under anaesthetic but will vary depending on local hospital practice. Once fitted with a permanent SNM device, it does not need to be removed unless there is an issue with the device, or the wire moves. The battery will need changing but the timing of this will vary depending on the type. It can also be removed if the participant no longer wants the device or finds it no longer useful in managing symptoms. Adherence monitoring: clinical assessment at 3 months post-randomisation, then telephone assessments every 3 months until 12 months post-randomisation, then data collection from medical notes at 24 months post-randomisation. Participants will complete questionnaires designed to capture health-related quality of life at baseline and 3 monthly throughout the 24-month follow-up period. Participants randomised to the RCT are given the opportunity to take part in up to 3 semi-structured interviews to explore the impact of the interventions.