Transperineal Ultrasound for Assessing and Predicting Response in Hospitalized Patients with a Flare of Ulcerative Colitis

Our aim is to determine how useful transperineal ultrasound is to assess the severity of inflammation in patients with ulcerative colitis. At the moment, there is a small amount of evidence showing it may be just as good as flexible sigmoidoscopy for this purpose. It is a non-invasive test, which means if it is equivalent, it may reduce the need for invasive tests like flexible sigmoidoscopy in the future. Patients admitted to hospital with a flare of ulcerative colitis will be invited to participate. Participants will undergo standard of care treatment and investigation. In addition to this, they will undergo a specialized non-invasive ultrasound test through the perineum (TPUS) as well as the abdomen (TA-IUS). The results from this will be compared to the current standard, flexible sigmoidoscopy. Patients will undergo repeat ultrasound and flexible sigmoidoscopy ten weeks after hospital discharge. We aim to show that transperineal ultrasound is useful for assessing disease severity and predicting the treatment course of hospitalized patients, and may be able to replace flexible sigmoidoscopy in some circumstances.

Ulcerative colitis is a chronic inflammatory disorder of the colon from which patients may experience acute disease 'flares', often requiring hospitalization. These flares may be severe and require aggressive immunomodulatory therapy to reduce morbidity and mortality. Disease severity is determined in-part by endoscopic severity, and so flexible sigmoidoscopy is indicated at admission in patients presenting with a disease flare. Not all patients respond to initial therapy, and assessing therapeutic response has traditionally been based on clinical and laboratory parameters (e.g. C-Reactive Protein, stool frequency, presence of blood). In our institution, after clinical and biochemical response, we assess for mucosal healing using flexible sigmoidoscopy, which is the treatment target set out in the STRIDE-2 guideline. This is generally performed ten weeks after admission, after stabilization on a maintenance treatment regimen and after steroids have been discontinued. Endoscopic assessment is invasive and expensive, and to optimize resource utilization there has been interest in alternative strategies to assess ulcerative colitis activity. Intestinal ultrasound (IUS) is a well-established imaging modality and has been shown to be sensitive and specific for colonic inflammation, and correlates well with endoscopy in patients with ulcerative colitis. A major limitation of trans-abdominal IUS (TA-IUS) is that assessment of the rectum is often difficult, with suboptimal views due to the position of the rectum deep within the pelvis. As ulcerative colitis nearly always involves the rectum and may not involve the remainder of the large bowel, traditional trans-abdominal IUS may miss significant active disease. Trans-perineal ultrasound offers an easy way to visualize the rectum and could serve as a useful adjunct to TA-IUS in the assessment of ulcerative colitis response to therapy, reducing the need for endoscopic assessment at follow-up. To date, there has been very little published data on TPUS in ulcerative colitis, though initial evidence is promising. Sagami et al. reported a strong correlation between colonoscopy and TPUS for assessment of rectal inflammation in ulcerative colitis, and reported excellent patient acceptability of TPUS, with patients expressing a preference for this modality over flexible sigmoidoscopy. These studies were conducted in a Japanese population, and there are no similar data validating the use or acceptability of TPUS in other populations. Hypothesis: TPUS will provide similar diagnostic accuracy when compared with flexible sigmoidoscopy in patients hospitalized with ulcerative colitis. All patients admitted with a flare of ulcerative colitis who meet the study inclusion criteria will be offered participation in the trial as near as feasible to the time of admission. Information regarding transperineal ultrasound and the data collected during the trial will be provided in written and verbal form, and written consen trial.show_full_description

Inclusion Criteria: * Patients aged \>= 18 years old * Presentation with a moderate or severe flare of ulcerative colitis as defined by standard clinical and laboratory criteria * Confirmed diagnosis of ulcerative colitis or clinical history consistent with the disease * Ability to provide informed consent and willingness to comply with study protocols Exclusion Criteria: * Pregnant women * Patients with severe comorbidities for whom endoscopic assessment is contraindicated * Patients with non-UC colitis (e.g. Crohn's colitis, ischaemic colitis) * Patients with active perianal disease deemed by the study coordinators as severe enough to preclude the comfortable use of trans-perineal ultrasound