NCT04169152 CAES for Internal Hemorrhoids and Rectal Prolapse
| NCT ID | NCT04169152 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Faming Zhang |
| Condition | Internal Hemorrhoid |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2019-12-30 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2019-12-30 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cap-assisted endoscopic sclerotherapy (CAES) is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse are still not clear due to the lack of large sample studies. Therefore, a nationwide multi-center, large sample, prospective and cohort study was designed to evaluate the efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse, to provide reliable evidence for popularization of this minimally invasive technology.
Eligibility Criteria
Inclusion Criteria: 1. Grade I-III internal hemorrhoids (with or without external hemorrhoids) or/and recal prolapse. 2. Patients with bowel preparation. Exclusion Criteria: 1. History of anoscopic/endoscopic sclerotherapy. 2. Acute thrombotic hemorrhoids or grade IV internal hemorrhoids. 3. Anal stenosis, perianal and perirectal abscess, anal fissure, fistula, fecal incontinence and other severe complications (such as severe anal pain). 4. Inflammatory bowel disease. 5. Full-thickness rectal prolapse through the anus. 6. Acute diarrhea in the past 24 hours. 7. Hypertensive with uncontrolled blood pressure. 8. Cerebrovascular accident. 9. Blood coagulation dysfunction. 10. Pregnant women. 11. Mental disorders. 12. Decompensated cirrhosis.
Contact & Investigator
Faming Zhang, MD,PhD
STUDY CHAIR
The Second Hospital of Nanjing Medical University
Frequently Asked Questions
Who can join the NCT04169152 clinical trial?
This trial is open to participants of all sexes, studying Internal Hemorrhoid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04169152 currently recruiting?
Yes, NCT04169152 is actively recruiting participants. Contact the research team at fzhang@njmu.edu.cn for enrollment information.
Where is the NCT04169152 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT04169152 clinical trial?
NCT04169152 is sponsored by Faming Zhang. The principal investigator is Faming Zhang, MD,PhD at The Second Hospital of Nanjing Medical University. The trial plans to enroll 10,000 participants.