A Study on the Endoscopic Treatments of Hemorrhoids

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhoids
• Intervention / Treatment: Other: performing endoscopy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 285
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fangyu Wang; Phone Number: +8613515100636; Email: wangfy65@nju.edu.cn
• Study Contact Backup: Name: Zhihao Ding; Phone Number: +8615061586037; Email: d382428060@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Jinling Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Sign a written informed consent form.
2. Age 18-80 years with clinical symptoms of hemorrhoids.
3. Subjects able to follow the follow-up schedule, able to describe symptoms objectively and able to cooperate in completing the scale.
4. non-breastfeeding pregnant women and those with no pregnancy planned during the trial
5. not participating in various clinical trials in the 3 months prior to and during the trial
6. Not taking long-term anticoagulant drugs (e.g., clopidogrel, aspirin, triptans, etc.) or have stopped taking them for 5-7 days.

Exclusion Criteria:

1. those with severe organ insufficiency of the heart, brain, lungs and kidneys
2. those who cannot tolerate endoscopic treatment
3. those with severe coagulation disorders
4. men with a history of severe prostate enlargement
5. with severe intestinal diseases: colon malignancy, ulcerative colitis, Crohn's disease, anal fistula, anal fissure, acute thrombosed internal hemorrhoids
6. those who are allergic to sclerosing agents
7. Those who, in the opinion of the investigator, cannot be enrolled for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: endoscopic sclerotherapy; Patients with hemorrhoids will be treated with endoscopic sclerotherapy. Injection site is submucosa of hemorrhoid nucleus. Sclerosing agent makes the submucosal tissue fibrotic, and then fixes the hemorrhoidal tissue.	Other: performing endoscopy; Hemorrhoids will be treated by endoscopic sclerotherapy or endoscopic rubber band ligation or endoscopic sclerotherapy combined with rubber band ligation; Other Names: drugs; device
Experimental: endoscopic rubber band ligation; Patients with hemorrhoids will be treated with endoscopic rubber band ligation. The ligature position is above the mucosa of the hemorrhoid nucleus. Ligation of hemorrhoidal tissue can lead to ischemic necrosis of the prolapsed mucosa, which in turn leads to scar fixation. At the same time, the ligature also has the effect of lifting the tissue upward.	Other: performing endoscopy; Hemorrhoids will be treated by endoscopic sclerotherapy or endoscopic rubber band ligation or endoscopic sclerotherapy combined with rubber band ligation; Other Names: drugs; device
Experimental: endoscopic sclerotherapy combined with rubber band ligation; Patients with hemorrhoids will be treated with endoscopic sclerotherapy combined with rubber band ligation. Sclerotherapy first, followed by rubber band ligation. Sclerotherapy injection reduces the likelihood of ligature dislodgement.	Other: performing endoscopy; Hemorrhoids will be treated by endoscopic sclerotherapy or endoscopic rubber band ligation or endoscopic sclerotherapy combined with rubber band ligation; Other Names: drugs; device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total effective rate	Total effective rate includes effective rate and cure rate. Effective rate means that symptoms are better than before treatment；Cure rate refers to the percentage of symptoms that completely disappear.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complications	Incidence of complications such as urinary retention, anal stricture, etc. within 1 year	1 year
Incidence of new symptoms	Incidence of new symptoms such as bleeding, pain, etc. within 1 year	1 year
Recurrence rate after treatment	Recurrence rate after 1 year of treatment	1 year
Patient satisfaction	A questionnaire was used to obtain patients' responses regarding their satisfaction with the treatment, with the following three options: satisfied, indifferent, and dissatisfied.	1 year
Endoscopic presentation of hemorrhoids	Circumferential distribution of hemorrhoids, the diameter of the largest hemorrhoids, presence of red color signs (change in the color of the surface of the rectal column in accordance with the general rules for endoscopic findings of esophagogastric varices)	1 year
Intraoperative situation	The amount of intraoperative bleeding and whether the patient had discomfort during the operation.	1 year
Number of days in hospital	Number of days in hospital	1 year
Hospitalization Costs	Hospitalization Costs	1 year
Incidence of needing re-treatment	Need for retreatment due to recurrence or worsening of symptoms	1 year

Collaborators and Investigators

• Sponsor: Fangyu Wang
• Collaborators: The Second Affiliated Hospital of Nanjing University of Chinese Medicine

Publications and helpful links

General Publications

• Yamana T. Japanese Practice Guidelines for Anal Disorders I. Hemorrhoids. J Anus Rectum Colon. 2018 May 25;1(3):89-99. doi: 10.23922/jarc.2017-018. eCollection 2017.
• Madoff RD, Fleshman JW; Clinical Practice Committee, American Gastroenterological Association. American Gastroenterological Association technical review on the diagnosis and treatment of hemorrhoids. Gastroenterology. 2004 May;126(5):1463-73. doi: 10.1053/j.gastro.2004.03.008. No abstract available.
• Ma W, Guo J, Yang F, Dietrich CF, Sun S. Progress in Endoscopic Treatment of Hemorrhoids. J Transl Int Med. 2020 Dec 31;8(4):237-244. doi: 10.2478/jtim-2020-0036. eCollection 2020 Dec.
• Davis BR, Lee-Kong SA, Migaly J, Feingold DL, Steele SR. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2018 Mar;61(3):284-292. doi: 10.1097/DCR.0000000000001030. No abstract available.
• Awad AE, Soliman HH, Saif SA, Darwish AM, Mosaad S, Elfert AA. A prospective randomised comparative study of endoscopic band ligation versus injection sclerotherapy of bleeding internal haemorrhoids in patients with liver cirrhosis. Arab J Gastroenterol. 2012 Jun;13(2):77-81. doi: 10.1016/j.ajg.2012.03.008. Epub 2012 Apr 24.
• Kanellos I, Goulimaris I, Christoforidis E, Kelpis T, Betsis D. A comparison of the simultaneous application of sclerotherapy and rubber band ligation, with sclerotherapy and rubber band ligation applied separately, for the treatment of haemorrhoids: a prospective randomized trial. Colorectal Dis. 2003 Mar;5(2):133-8. doi: 10.1046/j.1463-1318.2003.00395.x.
• Abiodun AA, Alatise OI, Okereke CE, Adesunkanmi AK, Eletta EA, Gomna A. Comparative study of endoscopic band ligation versus injection sclerotherapy with 50% dextrose in water, in symptomatic internal haemorrhoids. Niger Postgrad Med J. 2020 Jan-Mar;27(1):13-20. doi: 10.4103/npmj.npmj_128_19.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 16, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: DZQH-KYLLSL-21-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No