Early vs Delayed Surgery for Stricturing CD--a RCT
Early Versus Delayed Surgery for Symptomatic Stricturing Crohn's Disease : an Open-label, Single-center, Randomized Controlled Trial
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2022
CompletedStudy Start
First participant enrolled
June 9, 2022
CompletedFirst Posted
Study publicly available on registry
June 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
April 13, 2026
April 1, 2026
4.1 years
June 9, 2022
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
clinical remmision rate within 1 year
Crohn's disease activity index \< 150
within 1 year
Secondary Outcomes (6)
inflammatory bowel disease score
within 1 and 5 year
Crohn's disease obstructive score
within 1 and 5 year
endoscopic recurrence
within 1 and 5 year
medical cost
within 1 and 5 year
sugical recurrence
within 1 and 5 year
- +1 more secondary outcomes
Study Arms (2)
Biologic group
OTHERIf biologic(s) fails to provide relief, surgical intervention is considered. Following surgery, a prophylactic medication is offered based on the risk factors for recurrence
Surgery group
OTHERtreat paticipants with surgery and prophylactic medication according to the guidelines
Interventions
Eligibility Criteria
You may qualify if:
- with intestinal obstructive symptoms;
- confirmed intestinal strictures;
- traditional drugs failed to induce remission;
- envidence of active bowel inflammation;
- inappropriate for EBD;
- acquirement of written informed consent of participant;
You may not qualify if:
- unsuccessful medical treatment of intestinal obstruction;
- complete obstruction;
- contraindication for biologics;
- penetrating disease;
- short smaal bowel;
- suspicion of bowel tumor;
- no confirmed strictures;
- comitant severe disese of other system;
- obstructive symptoms under over 2 targets of biologics;
- successful treatment with traditional drugs;
- participate other clinical research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhu Weiminglead
Study Sites (1)
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, 210002, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- chief of general surgery
Study Record Dates
First Submitted
June 9, 2022
First Posted
June 16, 2022
Study Start
June 9, 2022
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
June 1, 2030
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share