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Assessment of constipation in patients with patients with inflammatory bowel disease using ultrasound

Sonographic Assessment of Constipation in Inflammatory Bowel Disease

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001207707
Enrollment
70
Registered
2022-09-08
Start date
2022-11-01
Completion date
2023-07-31
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Inflammatory bowel disease is a chronic and debilitating condition that affects 1 in 250 Australians. As many as 40% of patients with IBD have a concurrent diagnosis of irritable bowel syndrome with either constipation or diarrhoea as a major symptom. Delineating between inflammatory and functional symptoms can make assessment and management difficult in IBD. Concurrent functional symptoms frequentlyresult in unnecessary invasive investigations and even unnecessary escalation in already powerful immunosuppressive therapy. Constipation is the presence of solid or hard stools in the colon that are difficult to pass without significant exertion. They cause stretch, distension and bloating of the bowel which results in pain that can be difficult to differentiate from underlying inflammatory pain in some patients with concurrent IBD. Ulcerative colitis associated constipation is a phenomenon in which active inflammation results in a slowing of colonic motility and worsening of constipation, predominantly higher up in the colon (proximal constipation). This manifests as pain, bloating and discomfort and not only causes symptoms but can also impact the delivery of medications to the colon that rely on normal colonic movements. Intestinal ultrasound (IUS) has been used successfully across many countries to accurately and safely assess inflammatory bowel disease and allow for real-time decision making as a point of care test. It has been shown in small studies to be able to identify colonic contents such as solid or liquid stool, but this has not been formally defined. The ability of IUS to accurately distinguish between proximal faecal loading versus inflammatory pathology would allow a more safe, cost-effective and tailored approach to managing patients in real-time. Hypotheses: 1. IUS accurately and objectively measures proximal constipation in IBD as validated against CT as the reference standard 2. Unrecognised and frequent proximal constipation is a common cause for symptoms in participants with IBD 3. Proactive management of proximal constipation in IBD leads to an improvement in clinical symptoms and IUS parameters

Interventions

Patients undergoing intestinal ultrasound (IUS) as part of assessment of inflammatory bowel disease and found to have faecal loading will be referred for a single non-contrast low-dose CT scan (LDCT) to confirm the presence of faecal loading. There will not be any follow up LDCT in this study. The IUS will take approximately 20 minutes and will be performed by either a consultant gastroenterologist with over 7 years of experience with ultrasound or by a fellow currently training in IUS under sa

Patients undergoing intestinal ultrasound (IUS) as part of assessment of inflammatory bowel disease and found to have faecal loading will be referred for a single non-contrast low-dose CT scan (LDCT) to confirm the presence of faecal loading. There will not be any follow up LDCT in this study. The IUS will take approximately 20 minutes and will be performed by either a consultant gastroenterologist with over 7 years of experience with ultrasound or by a fellow currently training in IUS under said gastroenterologist. In cases where the fellow performs the ultrasound, the results will be verified by the supervising gastroenterologist prior to entry into the study. Participants invited to undergo a CT scan will be requested to do so immediately following their IUS clinic appointment (within 4 hours). Adherence will be confirmed by the generation of a LDCT radiology report.

Sponsors

Ryan Mathias
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Formal diagnosis of Inflammatory Bowel Disease (BD)

Exclusion criteria

o <18 years or >90 years of age o No formal diagnosis of inflammatory bowel disease o Participants who are pregnant or breastfeeding Participants who are unable to provide informed consent Participants who have undergone prior colonic surgery including restorative ileo-anal pouch anastomosis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026