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Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial

Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029323
Enrollment
Unknown
Registered
2020-01-25
Start date
2020-03-01
Completion date
Unknown
Last updated
2020-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

Experimental group:Laparoscopic bowel resection combined with postoperative Infliximab treatment
Control group:Infliximab

Sponsors

Renji Hospital, School of Medicine, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age in between 18 and 80 years; 2. ASA I~II level; 3. Localized intestinal Crohn's disease (Intestinal CD affecting 220 points); 5. CD patients with high risk factors, including combined perianal lesions, small age of onset, corticosteriods therapy for the first treatment; 6. Patients have sufficient organ function; 7. Patients or family members are able to understand the study and sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous use of IFX treatment; 2. Concomitant IFX contraindications, including: various types of heart disease (viral myocarditis, etc.), acute infection period, demyelinating diseases of the nervous system, and various infectious diseases such as tuberculosis, hepatitis B, and cytomegalovirus infection; 3. Abdominal abscess, cellulitis or ascites; 4. Insufficient surgery such as severe emphysema, pulmonary bullae, interstitial pneumonia or ischemic heart disease; 5. Pregnant or lactating women; 6. Severe mental illness; 7. Continuous systemic steroid treatment within 1 month; 8. There are contraindications for laparoscopic surgery; 9. Combining malignant tumors.

Design outcomes

Primary

MeasureTime frame
Endoscopic remission;

Secondary

MeasureTime frame
Clinical remission;Surgery rate;Life quality;Crohn's disease related consumption;Crohn‘s disease related morbidity;

Countries

China

Contacts

Public ContactYu Minhao

enji Hospital, School of Medicine, Shanghai Jiaotong University

fishmeangood@163.com+86 13661594237

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026