Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a...

Area of Science:

• Gastroenterology
• Endoscopic procedures
• Surgical techniques

Background:

• Cap-assisted endoscopic sclerotherapy is an emerging colonoscopy technique for internal hemorrhoids and rectal prolapse.
• Optimal endoscopic injection needle length is crucial for efficacy and safety but lacks clinical guidance.
• This study addresses the need for data on injection needle length in cap-assisted endoscopic sclerotherapy.

Purpose of the Study:

• To evaluate the efficacy and safety of cap-assisted endoscopic sclerotherapy using long versus short injection needles for internal hemorrhoids.
• To determine the impact of injection needle length on recurrence rates and patient outcomes.
• To provide evidence-based recommendations for needle selection in this endoscopic therapy.

Main Methods:

• A nationwide, multi-center, prospective, single-blind, randomized controlled trial (NCT03917056).
• Inclusion of patients with Grade I-II internal hemorrhoids unresponsive to conservative treatment and Grade III patients unsuitable for or refusing surgery.
• Randomization of participants (1:1) into long or short injection needle groups, with outcomes assessed at 24 weeks post-procedure.

Main Results:

• Primary outcome: recurrence rate of internal hemorrhoids at 24 weeks.
• Secondary outcomes: symptom severity, quality of life (EuroQoL-5D), adverse events, and patient attitudes.
• Data collection points include pre-procedure, during operation, and at 1 day, 1 week, 2 weeks, and 24 weeks post-procedure.

Conclusions:

• Expected to establish a practical clinical protocol for cap-assisted endoscopic sclerotherapy.
• Aims to promote the adoption and refinement of this novel endoscopic technique for internal hemorrhoid treatment.
• Will offer guidance on optimal endoscopic injection needle selection for improved patient outcomes.