Actively Recruiting

All Genders
ID04169152

Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: National Multi-center Prospective Cohort Study

Led by Faming Zhang ยท Updated on 2024-04-02

10000

Participants Needed

1

Research Sites

26 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Brief Title

CAES for Internal Hemorrhoids and Rectal Prolapse

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Grade I-III internal hemorrhoids (with or without external hemorrhoids) or/and rectal prolapse
  • Patients who have undergone bowel preparation
Not Eligible

You will not qualify if you...

  • History of anoscopic or endoscopic sclerotherapy
  • Acute thrombotic hemorrhoids or grade IV internal hemorrhoids
  • Anal stenosis, perianal or perirectal abscess, anal fissure, fistula, fecal incontinence, or other severe complications such as severe anal pain
  • Inflammatory bowel disease
  • Full-thickness rectal prolapse through the anus
  • Acute diarrhea within the past 24 hours
  • Uncontrolled hypertension
  • History of cerebrovascular accident
  • Blood coagulation dysfunction
  • Pregnant women
  • Mental disorders
  • Decompensated cirrhosis

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Post-treatment Follow-up

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)

Trial Site Locations

Total: 1 location

1

Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210011

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Research Team

F

Faming Zhang, MD,PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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