NCT03917056

Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to evaluate the efficacy and safety of long needle and short needle in the treatment of internal hemorrhoids and rectal prolapse through CAES (Cap-assisted endoscopic sclerotherapy).

Detailed description

Traditional endoscopic sclerotherapy for internal hemorrhoids require retroflection of the endoscope. Retroflection of the endoscope has blind areas and affects the precise operation. And, short-needle injection can easily lead to artificial ulcer and secondary bleeding. CAES is a new, minimally invasive endoscopic technique for the treatment of internal hemorrhoids and rectal prolapse. CAES was performed based on the requirement of the cap, endoscope, disposable endoscopic long injection needle, enough insufflated air and sclerosing agent. It can accurately control the injection angle, direction and depth under direct vision, and avoid iatrogenic injury caused by ectopic injection to the greatest possible extent. To investigate the effect of long needle and short needle on the outcome of CAES, participants with internal hemorrhoids and rectal prolapse were randomly assigned to a long needle group and a short needle group using a prospective, randomized, controlled study at multiple centers in China. The efficacy, adverse events and satisfaction of the two groups were observed.

Conditions

• Internal Hemorrhoid
• Rectal Prolapse

Interventions

Type	Name	Description
PROCEDURE	Cap-assisted endoscopic sclerotherapy using long needle	Participants were treated with CAES using long needle.
PROCEDURE	Cap-assisted endoscopic sclerotherapy using short needle	Participants were treated with CAES using short needle.

Timeline

• Start date: 2019-06-24
• Primary completion: 2025-03-01
• Completion: 2025-03-27
• First posted: 2019-04-16
• Last updated: 2024-04-02

Locations

1 site across 1 country: China