NCT07167745Befejeződött
Tracking the Natural Course of Silent Small Bowel Narrowing in Adults With Crohn's Disease
SMALL BOWEL INCIDENTAL STRICTURES: EVALUATION OF NATURAL HISTORY IN ASYMPTOMATIC CROHN'S EVOLUTION (SILENCE STUDY)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 11.
Rövid összefoglaló (regiszter, angolul)
Crohn's disease is a long-term condition that causes inflammation in the digestive tract. Over time, some people develop narrowings in the small intestine, called "strictures." These strictures can block food and cause symptoms like abdominal pain, bloating, nausea, or vomiting. However, strictures are sometimes found by chance in people who have no symptoms. These are called "asymptomatic" or "silent" strictures. Doctors do not know how often silent strictures become a problem or whether it is better to treat them early or simply monitor them. Current treatments for Crohn's disease are not very effective at reversing scar tissue once it forms, and there are no clear guidelines for what to do when a silent stricture is found. The SILENCE study will look at the natural course of silent small bowel strictures in adults with Crohn's disease. Researchers will review the medical records of people aged 18 and older who were diagnosed with a silent small bowel stricture between 2015 and 2023. All participants must have at least one year of follow-up information available. The study will record: How often strictures become symptomatic (cause abdominal pain, nausea, vomiting, bloating, or other symptoms) Whether patients require treatments such as changes in medication, endoscopic dilation, or surgery Any changes in the size or severity of the stricture seen on imaging or endoscopy The study will also compare two groups: People whose silent stricture was found at the same time as their Crohn's diagnosis People with Crohn's in remission for at least two years before developing a silent stricture Researchers will examine possible risk factors for progression, such as age, smoking status, prior treatment, and results from blood or stool tests. By understanding how silent strictures behave over time, this study aims to help doctors decide when it is safe to observe and when intervention might be needed. The findings could improve patient care and inform future treatment guidelines for Crohn's disease.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 150 (tényleges)
- Első benyújtás
- 2025. szept. 3.
- Kezdés
- 2025. jún. 9.
- Elsődleges befejezés
- 2025. aug. 30.
- Fő szponzor
- University Medical Center Zvezdara
- Betegségek
- Crohn-betegség
- NCT-szám
- NCT07167745
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 150
- 2025. jún. 9. és az elsődleges befejezés (2025. aug. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Strictures attributable to neoplastic processes, prior radiation therapy, or congenital anomalies.
- History of prior small bowel or colonic resection.
Egyéb
- Presence of symptomatic strictures at the time of stenosis detection.
- Incomplete clinical data or follow-up
- Strictures are located exclusively in the colon.
- Clinical symptoms of active CD at the time the stricture was identified.
Kiket keres a vizsgálat
- • Patients who are asymptomatic, with no clinical signs of intestinal symptomatology (absence of abdominal pain, distension, nausea, vomiting, weight loss, diahorrea).
- Patients 18 years and older
- Small bowel stricture diagnosed incidentally either:
- at the time of initial Crohn's disease (CD) diagnosis (baseline visit), or
- in patients with a previously established diagnosis of mild CD who have maintained stable clinical, endoscopic and radiographic remission without previous stenosis for a minimum of 2 years prior to study entry.
- Diagnosis of Crohn's disease confirmed according to accepted clinical, endoscopic, radiologic, and/or histologic standards.
- Evidence of small bowel involvement by CD, either in the form of ileal, ileocolonic or jejunal disease. Presence of a small bowel stricture confirmed by MR enterography, intestinal ultrasound (IUS), or endoscopy.
- Only patients who have at least one year of longitudinal follow-up data in the medical record after the baseline/index evaluation will be included.
- Patients who went to colonoscopy due to asymptomatic iron deficiency anemia and/or positive fecal occult blood test or for routine CD follow up
- Minimum follow up period is one year, or event happened whichever comes first
Életkor a regiszterben: 18 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University Hospital Zvezdara Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Belgrade | Szerbia | Ismeretlen állapot |
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