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Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial

Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-ICR-15007188
Enrollment
Unknown
Registered
2015-10-09
Start date
2015-10-09
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Ulcerative colitis

Interventions

Control Group:Oral steroids (prednisone 1mg.kg-1d-1) andmesalazine 3g / d
Percutaneous endoscopic mini-colostomy group:Oral steroids (prednisone 1mg.kg-1d-1) +Percutaneous endoscopic mini-colostomy andsubsequent drug delivery (mesalazine 3g / d)

Sponsors

Southern Medical University, Nanfang Hospital, Department of Gastroenterology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) a clear diagnosis of mild andmoderate, active widely colon (E3) UC patients; (2) the absence of colonoscopy andendoscopy guided puncture contraindications; (3) patients agreed to participate in this study andsigned informed consent.

Exclusion criteria

Exclusion criteria: (1) severe abdominal skin infections andwounds patient; (2) uncorrectable coagulopathy patients; (3) combined with cardiac, cerebrovascular, liver, kidney andhematopoietic system andother serious primary disease; (4) mental disorders andpoor patient compliance; (5) pregnant andlactating women.

Design outcomes

Primary

MeasureTime frame
Mayo score;success rates of percutaneous endoscopic mini-colostomy;Intraoperative complications;Postoperative complications;

Secondary

MeasureTime frame
Operation time;blood loss of the operation;Length of stay;Hospital costs;blood routine examination;Serum Albumin;Electrolyte;ESR;C-reactive protein;

Countries

China

Contacts

Public ContactSide Liu
liuside2011@163.com+86 13902212459

Outcome results

None listed

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