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| Name | Class |
|---|---|
| Australasian Gastro Intestinal Research Foundation | OTHER |
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Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.
Prospective randomised controlled study. Patients with Crohn's Disease and symptomatic stricture(s) will undergo randomisation to receive standard or intensive endoscopic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard endoscopic therapy | Active Comparator | Single endoscopic dilatation |
|
| Intensive endoscopic therapy | Experimental | 3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard (single) endoscopic stricture dilatation | Procedure | single endoscopic stricture dilatation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS). | The Obstructive Symptom Score (OSS) is a composite measure of the total number of days of obstructive abdominal pain and the severity over a fourteen-day period using a 5-point Likert scale. (no pain, mild, moderate, severe, unbearable) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in obstructive symptoms using the Obstructive Symptom Score (OSS). | The Obstructive Symptom Score (OSS) is a composite measure of the total number of days of obstructive abdominal pain and the severity over a fourteen-day period using a 5-point Likert scale. (no pain, mild, moderate, severe, unbearable) | 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien Schulberg, MBBS | Contact | +61 3 92312211 | stridentstudy@svha.org.au | |
| Amy Hamilton, PhD | Contact | +61 3 92312211 | stridentstudy@svha.org.au |
| Name | Affiliation | Role |
|---|---|---|
| Emily Wright, MBBS PhD | St Vincent's Hospital Melbourne | Principal Investigator |
| Bronte Holt, MBBS PhD | St Vincent's Hospital Melbourne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital Melbourne | Recruiting | Melbourne | Victoria | 3065 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39343051 | Derived | Schulberg JD, Hamilton AL, Wright EK, Holt BA, Sutherland TR, Ross AL, Vogrin S, Kamm MA. Repeated endoscopic dilation and needle-knife stricturotomy for Crohn's disease strictures. Gastrointest Endosc. 2025 Jan;101(1):202-206.e4. doi: 10.1016/j.gie.2024.09.031. Epub 2024 Sep 27. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
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Randomised controlled trial
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Open label study
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| Intensive endoscopic stricture dilatation | Procedure | 3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty |
|
| Improvement in imaging parameters |
MRI and intestinal ultrasound |
| 6 months |
| Improvement in endoscopic features | Increased patency of strictures on endoscopy | 6 months |
| Avoidance of surgery | Requirement for surgical resection of stricture | 6 months |
| Improvement in patient reported outcomes (PROs) | IBDQ | 6 months |
| Improvement in patient reported outcomes (PROs) | SF36 | 6 months |
| Technical success of procedure | Successful endoscopic procedure | At time of procedure |
| Michael Kamm, MBBS PhD |
| St Vincent's Hospital Melbourne |
| Principal Investigator |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012959 |
| Socioeconomic Factors |