Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial

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.

Long-term efficacy and safety of cap-assisted endoscopic sclerotherapy with long injection needle for internal hemorrhoids

“…This study evaluated the long-term efficacy and safety of long needle CAES for symptomatic internal hemorrhoids. In Zhang’s et al report[ 5 , 8 , 9 , 16 , 17 ], the follow-up for CAES treatment did not exceed one year. In our study, the time for following CAES treatment was up to 5 years.…”

Hemorrhoidal Disease: How to Proceed After Unsuccessful Medical Treatment?

“…The procedure is typically performed on an outpatient basis and may be repeated as necessary to achieve the desired results. Studies have reported varying success rates of sclerotherapy in treating hemorrhoids, depending on the severity of the condition and other factors [39,40]. However, on average, sclerotherapy has been shown to have a success rate of approximately 70-80% in treating first-and second-degree hemorrhoids.…”

Rationale, new anus positioning methods, and updated protocols: Expert recommendations on cap-assisted endoscopic sclerotherapy for hemorrhoids from China Gut Conference

“…For patients only with bleeding hemorrhoids, both long and short needles can be selected for injection. [ 4 , 7 ] The long needle is recommended for the hemorrhoids combined with prolapse. The sclerosing agent is injected into the submucosal layer for about 5 s with 0.5 to 2.0 mL lauromacrogol per site.…”

“…The CAES procedure-associated complications were mainly reported from physicians who were in the early stage of CAES training. [ 7 ] Enema is the way to solve the difficulty in passing gas and defecation, and lower intestinal obstruction. [ 7 ]…”

“…[ 7 ] Enema is the way to solve the difficulty in passing gas and defecation, and lower intestinal obstruction. [ 7 ]…”