Cap-assisted endoscopic sclerotherapy for treating hemorrhoids and rectal prolapse

Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: a Nationwide Multicenter Randomized Controlled Trial

This study is testing a new way to treat internal hemorrhoids and rectal prolapse using a special technique with long and short needles to see which one works better and keeps patients safer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Sex: All
• Sponsor: The Second Hospital of Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT03917056 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of cap-assisted endoscopic sclerotherapy (CAES) using long and short needles for treating internal hemorrhoids and rectal prolapse. The study addresses limitations of traditional endoscopic sclerotherapy, which can lead to complications due to blind areas during retroflection. Participants are randomly assigned to receive treatment with either a long or short needle, allowing for precise control of injection under direct vision. The trial aims to assess the outcomes, adverse events, and patient satisfaction associated with both techniques.

Who should consider this trial

Good fit: Ideal candidates include patients with internal hemorrhoids and rectal prolapse, with or without external hemorrhoids, who have undergone bowel preparation.

Not a fit: Patients with serious internal hemorrhoids of grade IV, anal stenosis, or other significant gastrointestinal conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients suffering from internal hemorrhoids and rectal prolapse.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving treatment outcomes for hemorrhoids, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Patients with internal hemorrhoids and rectal prolapse, combined with external hemorrhoids or without external hemorrhoids.
2. Patients with bowel preparation.

Exclusion Criteria:

1. History of anoscopic/endoscopic sclerotherapy.
2. Patients with acute thrombotic external hemorrhoids.
3. Patients with serious internal hemorrhoids of grade IV.
4. Patients with anal stenosis, anal fissure, fistula, fecal incontinence, ulcerative colitis, Crohn's disease.
5. Patients with acute diarrhea in the past 24 hours.
6. Hypertensive patients with uncontrolled blood pressure, patients with cerebrovascular accident and obvious bleeding tendency, pregnant women, mental disorders and decompensated cirrhosis.

Where this trial is running

Nanjing, Jiangsu

• Fmt-Dt-N-27/1350 — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Faming Zhang, MD,PhD — The Second Hospital of Nanjing Medical University
• Study coordinator: Faming Zhang, MD,PhD

Conditions: Internal Hemorrhoid, Rectal Prolapse, Cap-assisted endoscopic sclerotherapy