Cap-assisted endoscopic sclerotherapy for hemorrhoids: Methods, feasibility and efficacy.
Ting Zhang, Li-Juan Xu, Jie Xiang...
https://pubmed.ncbi.nlm.nih.gov/26722615Actively Recruiting
Led by Faming Zhang ยท Updated on 2024-04-02
10000
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are evaluating the long-term effectiveness and safety of cap-assisted endoscopic sclerotherapy (CAES) for treating internal hemorrhoids and rectal prolapse. CAES is a new minimally invasive procedure performed during colonoscopy that aims to improve treatment precision and reduce pain and injury. This nationwide, multi-center, prospective cohort study seeks to provide solid evidence to support the wider use of this technique. The treatment involves using a colonoscope with a special cap to fully expose the area being treated. A specially designed long injection needle helps the doctor control the injection angle and depth under direct vision, which may reduce risks. During the procedure, doctors can also diagnose other conditions like tumors or inflammatory bowel disease and provide therapy for lower-gut issues during the same session, lowering medical costs and patient discomfort. Participants will undergo CAES treatment and be followed up regularly to assess outcomes. Researchers will track recurrence rates from the first week to 24 weeks after treatment, as well as improvement and failure rates at multiple points within that period. They will also monitor quality of life, adverse events, symptom severity, and participants' attitudes toward the procedure. The study aims to confirm the long-term safety and benefits of CAES over several months.
CONDITIONS
CAES for Internal Hemorrhoids and Rectal Prolapse
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo Cap-assisted endoscopic sclerotherapy (CAES), an innovative procedure to treat internal hemorrhoids and rectal prolapse with precise control under direct vision of a flexible endoscope.
1 treatment visit (in-person)
Duration - 24 weeks
Participants are monitored through follow-up visits to assess treatment outcomes, adverse events, symptom severity, and health status up to 24 weeks after treatment.
Visits on Day 1, Week 1, Week 2, and Week 24 (in-person)
Total: 1 location
1
Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
Actively Recruiting
F
Faming Zhang, MD,PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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