NCT05268575

A Study on the Endoscopic Treatments of Hemorrhoids

Comparative Study on Endoscopic Treatments for Hemorrhoids (METHOD): a Multicenter, Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 285 (estimated)
• Sponsor: Fangyu Wang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Hemorrhoids is one of the most common anorectal diseases, can occur at any age and gender. Hemorrhoids generally do not have very serious clinical manifestations, but often bring huge life pressure and psychological burden to patients, so effective treatment is necessary. Traditional surgical treatment techniques, such as hemorrhoidectomy, may have defects such as anal pain and long recovery time. Recently, endoscopic hemorrhoid treatment has become a safe, effective and rapid rehabilitation treatment. Treatment of hemorrhoids treatment including endoscopic sclerotherapy, endoscopic rubber band ligation, endoscopic sclerotherapy combined with rubber band ligation, the three kinds of treatment methods have their own advantages, but existing research at home and abroad is still less and the comparison of various treatment methods lack of consensus. Our study is to compare the three kinds of treatment methods.

Detailed description

In this trial, investigators plan to conduct a multicenter, randomized controlled clinical trial. The leader of the sponsoring organization strictly implements oversight of the protocol. Investigators intend to compare the total efficiency of the endoscopic sclerotherapy group, the endoscopic rubber band ligation group, and the endoscopic sclerotherapy combined with rubber band ligation group for the treatment of hemorrhoids. The Department of Gastroenterology at Jinling Hospital will take full charge of this trial, including recruitment of patients, endoscopic treatment, in-hospital nursing, follow-up work, etc. Informed consent forms from every patient will be signed before enrollment, and approval from the Ethical Committees of Jinling Hospital has been obtained. After patients will be admitted to the hospital and sign informed consent, they will be randomly assigned to the endoscopic sclerotherapy group, the endoscopic rubber band ligation group, and the endoscopic sclerotherapy combined with rubber band ligation group in a 1:1:1 ratio of 130 patients in each group, and the assignment will be done by a mobile client randomization tool. Patients in each group completed bowel preparation according to the same requirements and performed the appropriate endoscopic treatment. The sclerosing agent is polydocanol and the ligature model is MBL-6-F. Our main observation is the overall effectiveness rate (the ratio of the number of people whose symptoms improved and the number of people whose symptoms completely disappeared to the total number of people). Our secondary observation indicators are the incidence of complications (such as urinary retention, prostatic abscess, fecal incontinence, rectal stricture, infection, bacteraemia, etc.) within 1 year after hemorrhoid treatment, the presence of new symptoms within 1 year after treatment, the recurrence rate after treatment, patient satisfaction, endoscopic performance of hemorrhoids, intraoperative conditions, hospital days, hospital costs, the need for retreatment due to recurrence or worsening of symptoms, blood routine, urine routine, fecal routine, coagulation function, blood biochemistry, etc. Investigators will observe the status of patients 48 hours after treatment, 3 month after treatment, 6 months after treatment, 9 months after treatment, and 1 year after treatment. Follow-up will be conducted through online questionnaires or telephone callbacks.

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
OTHER	performing endoscopy	Hemorrhoids will be treated by endoscopic sclerotherapy or endoscopic rubber band ligation or endoscopic sclerotherapy combined with rubber band ligation

Timeline

• Start date: 2022-05-30
• Primary completion: 2024-09-01
• Completion: 2025-01-01
• First posted: 2022-03-07
• Last updated: 2022-04-22

Locations

1 site across 1 country: China