Skip to content

Efficacy and safety of laser closure for treatment of anal fistula in Crohn's disease: a prospective single-arm study

Efficacy and safety of laser closure for treatment of anal fistula in Crohn's disease: a prospective single-arm study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120994
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-03-25
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Crohn's disease anal fistula

Interventions

Treatment group:Patients enrolled in the study were clinically diagnosed with Crohn's disease-related anal fistula. Following reassessment confirming controlled or stable fistula status, laser closure

Sponsors

Renji Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18–60 years old; 2. Patients with moderate-to-severe active Crohn's disease (CD), defined as a CDAI score > 220 points; 3. Patients clinically diagnosed with Crohn's disease anal fistula based on medical history, physical examination, and ancillary tests, requiring surgical intervention; 4. No prior treatment with biologic agents; 5. ASA I-II status with adequate organ function; 6. Voluntary participation in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrollable severe infections in the rectum and perianal area; 2. Patients with contraindications to biologic agents, including but not limited to: severe cardiac disease, acute infections, demyelinating neurological disorders, tuberculosis, hepatitis B, cytomegalovirus infection, and other infectious diseases; 3. Patients who have received systemic steroid therapy within the past month; 4. Patients with concomitant autoimmune diseases or malignancies; 5. Patients unable to tolerate surgery due to severe emphysema, pulmonary bullae, interstitial pneumonia, ischemic heart disease, or coagulation disorders; 6. Vulnerable populations, including critically ill patients, individuals with psychiatric disorders, those with cognitive impairment, pregnant or lactating women, minors, and illiterate individuals; 7. Patients or family members unable to comprehend the conditions and objectives of this study.

Design outcomes

Primary

MeasureTime frame
Anal fistula healing rate;

Secondary

MeasureTime frame
Imaging-based fistula healing rate;PDAI Score;CDAI Score;Wexner Score;

Countries

China

Contacts

Public ContactYu Minhao

Renji Hospital, Shanghai Jiao Tong University School of Medicine

fishmeangood@163.com+86 136 6159 4237

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026