Abstract
Background:Cap-assisted endoscopic sclerotherapy is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. The proper length of the endoscopic injection needle is the core for performing cap-assisted endoscopic sclerotherapy well with more benefits and less complications. However, no data are currently available to guide endoscopists to consider the length of injection needle before cap-assisted endoscopic sclerotherapy. This study is designed to evaluate the efficacy and safety of cap-assisted endoscopic sclerotherapy with long or short injection needle in the treatment of internal hemorrhoids.Methods:This is a nationwide multi-center, prospective, single-blind and randomized controlled trial. Patients with grade I-II internal hemorrhoids who have failed to conservative treatments and grade III internal hemorrhoids who are not suitable for surgery or refuse surgery will be included. Participants will be randomized 1:1 into either long or short injection needle group. The primary outcome is the recurrence rate of internal hemorrhoids 24 weeks after cap-assisted endoscopic sclerotherapy. The secondary outcomes are as follows: (1) symptom severity score, (2) three-level EuroQoL five dimensions health scale scores, (3) occurrence of adverse events and severe adverse events, and (4) patients’ attitudes toward cap-assisted endoscopic sclerotherapy. Data collection will be conducted before and during operation, the 1st day, 1st week, 2nd week, and 24th week after cap-assisted endoscopic sclerotherapy.Discussion:The outcome of this study is expected to provide a practical clinical protocol of cap-assisted endoscopic sclerotherapy for patients with internal hemorrhoids and promote the use of this new endoscopic technique.Trial registration:ClinicalTrials.gov, NCT03917056. Registered on 12 April 2019.
Highlights
Cap-assisted endoscopic sclerotherapy is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy
A nationwide multi-center, prospective, single-blind, and randomized controlled trial was designed to evaluate the efficacy and safety of cap-assisted endoscopic sclerotherapy (CAES) with long or short injection needle in the treatment of internal hemorrhoids, to provide reliable evidence for popularization of this minimally invasive technology
Through the Chinese time trade-off (TTO) value table, the health status of five dimensions will be converted into a preference weight of a ED-5Q index score for further analysis.[22] (3) AEs and SAEs: AEs refer to adverse medical events that occur during or after CAES, including bleeding, anal pain, having difficulties in passing gas and defecation, urinary retention, infection, ulcer/ bleeding in the injection points under endoscopic examination (5–7 days after CAES), and other symptoms
Summary
Hemorrhoids are collection of submucosal, fibrovascular, arteriovenous sinusoids that are part of the normal anorectum.[1]. A nationwide multi-center (centers and participants involved in the trial were listed in Supplementary Data), prospective, single-blind, and randomized controlled trial was designed to evaluate the efficacy and safety of CAES with long or short injection needle in the treatment of internal hemorrhoids, to provide reliable evidence for popularization of this minimally invasive technology
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