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Clinical application of Kui-Jie gel combined with sphincter-preserving fistulectomy for the treatment of perianal fistulizing Crohn's disease

Clinical application of Kui-Jie gel combined with sphincter-preserving fistulectomy for the treatment of perianal fistulizing Crohn's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000691
Enrollment
Unknown
Registered
2024-11-12
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Perianal fistulizing Crohn's disease

Interventions

Control group:Loose seton
SPF group:Sphincter- preserving fistulectomy
Kui-Jie+SPF group:Combination sphincter- preserving fistulectomy with Kui-Jie gel

Sponsors

Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Patients with perianal fistulizing CD who meeting the WHO diagnostic criteria; (2) Age between 16 and 60 years old and any gender; (3) Transsphincteric or suprasphincteric anal fistula according to Parks classification criteria; (4) Internal opening of the fistula locating in the anal canal; (5) Ustekinumab treatment for intestinal CD; (6) Signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Age less than 16 years or more than 60 years; (2) Intersphincteric or extra-sphincteric anal fistula according to the Parks classification criteria; (3) Internal opening of the fistulae locating in the rectum; (4) Combination of intestinal tuberculosis stenosis or obstruction; (5) Pregnant and lactating women; (6) Combination of liver kidney cardiovascular and haematological system serious diseases and mental diseases; (7) Infliximab adalimumab vedolizumab upapatinib for intestinal CD; (8) Preoperative anal incontinence; (9) Combined perianal abscess; (10) Failure to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Clinical and imaging healing rates of fistula;Healing time;Fistula recurrence rate;—

Secondary

MeasureTime frame
General indications: including name sex age disease duration etc.;Fistula-related indications: fistula classification location number of branches previous surgical history etc.;Quality of life;Neutrophil extracellular traps indicators;Indicators related to epithelial mesenchymal transition;Inflammatory cytokine levels in wound tissue;Anal continence function;Anal fistula activity;Flora distribution on wound tissue;Intestinal CD activity;Surgical complications and drug adverse events: incision infection bleeding mucosal flap necrosis drug allergy tingling etc.;—

Countries

China

Contacts

Public ContactXue-Liang Sun

Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine

sunxueliang-2005@163.com13862429687

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026