Crohn Disease
Conditions
Brief summary
The management of stricturing Crohn's disease (CD) remains challenging. Although surgical resection may be the final way to solve it, the efficacy of biologics for symptomatic CD associated strictures was acceptable. In clinical practice, the chioce of treatment is particularly difficult. Therefore, a clinical trial of biologics versus surgery is needed to assess which one is prefered.
Interventions
DRUGGroup A
treat participants with biologics
PROCEDUREGroup B
treat participants with surgery
Sponsors
Zhu Weiming
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. with intestinal obstructive symptoms; 2. confirmed intestinal strictures; 3. traditional drugs failed to induce remission; 4. envidence of active bowel inflammation; 5. inappropriate for EBD; 6. acquirement of written informed consent of participant;
Exclusion criteria
1. unsuccessful medical treatment of intestinal obstruction; 2. complete obstruction; 3. contraindication for biologics; 4. penetrating disease; 5. short smaal bowel; 6. suspicion of bowel tumor; 7. no confirmed strictures; 8. comitant severe disese of other system; 9. obstructive symptoms under over 2 targets of biologics; 10. successful treatment with traditional drugs; 11. participate other clinical research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical remmision rate within 1 year | within 1 year | Crohn's disease activity index \< 150 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inflammatory bowel disease score | within 1 and 5 year | 32-224；the higher the better |
| Crohn's disease obstructive score | within 1 and 5 year | 0-6； the higher the worse |
| endoscopic recurrence | within 1 and 5 year | Rutgeert score \>i2b (i0-i4); the higher the worse |
| medical cost | within 1 and 5 year | cost for hospitalization |
| sugical recurrence | within 1 and 5 year | disease recurrence that needs surgical resection |
| clinical remmision rate within 5 year | within 5 year | CDAI\>150 |
Countries
China
Contacts
CONTACTWeinming Zhu, Ph.D.
Outcome results
None listed