NCT06717906Completed
Comparing TRIple Rectal Ultrasound Imaging Technology in Ulcerative Colitis
Comparing Three Modalities (Trans Abdominal, Trans-perineal and Endoscopic Ultrasound) of Ultrasonography for Rectal Imaging in Ulcerative Colitis: The TRINITY Study
Source: ClinicalTrials.gov · Last updated 17 Jul 2025
Brief summary (registry, in English)
This study aims to evaluate the correlation of rectal wall thickness and vascularity measurements using trans-abdominal ultrasound (TAS), trans-perineal ultrasound (TPUS), and endoscopic ultrasound (EUS) in adult patients with ulcerative colitis (UC). The primary objective is to correlate rectal total wall thickness measured by TPUS with EUS, while secondary objectives include correlating rectal wall thickness and vascularity as measured by TAS, TPUS, and EUS, with endoscopic and histologic activity. Additionally, the study will assess changes in patient management following EUS/sigmoidoscopy compared to TAS/TPUS alone. Consecutive UC patients attending an IBD clinic will undergo clinical assessment using the Simple Clinical Colitis Activity Index (SCCAI) followed by TAS and TPUS as point-of-care tests. If clinically indicated, patients will also undergo sigmoidoscopy and EUS during the same visit, with measurements compared and correlated to histologic inflammation and fecal calprotectin (FCP) levels when available. This cross-sectional study will include a follow-up period until biopsy results are obtained, with a recruitment duration of 6-12 months and a target sample size of 170 patients (60 patients with mid-end ultrasound machine, rest with high-end ultrasound machine for transabdominal and transperineal ultrasound).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 142 (actual)
- First submitted
- 18 Aug 2024
- Start date
- 27 May 2024
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Diseases
- Ulcerative colitis
- NCT number
- NCT06717906
What you commit to
- Study type: Interventional
- Participants enrolled: 142
- From 27 May 2024 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Pregnant
- Lactating mother
- Endoscopy not required
- No consent
Who the study is looking for
- Adult patients (18-75 years) with Ulcerative colitis
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asian Institute Of Gastroenterology Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.