A Study on the Endoscopic Treatments of Hemorrhoids

NCT05268575 | Unknown

• 1 other identifier: DZQH-KYLLSL-21-15
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incidence of complications

  1 year

• Incidence of new symptoms

  1 year

• Recurrence rate after treatment

  1 year

• Patient satisfaction

  1 year

• Endoscopic presentation of hemorrhoids

  1 year

Study Arms (3)

endoscopic sclerotherapy

EXPERIMENTAL

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

endoscopic rubber band ligation

EXPERIMENTAL

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

endoscopic sclerotherapy combined with rubber band ligation

EXPERIMENTAL

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

Interventions

performing endoscopy OTHER

Hemorrhoids will be treated by endoscopic sclerotherapy or endoscopic rubber band ligation or endoscopic sclerotherapy combined with rubber band ligation

Also known as: drugs, device

endoscopic rubber band ligation; endoscopic sclerotherapy; endoscopic sclerotherapy combined with rubber band ligation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fangyu Wang: lead
• The Second Affiliated Hospital of Nanjing University of Chinese Medicine: collaborator

Study Sites (1)

Jinling hospital

Nanjing, Jiangsu, 210002, China

Location

Related Publications (7)

• 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.

  PMID: 31583307 BACKGROUND

• 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.

  PMID: 15131807 BACKGROUND

• 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.

  PMID: 33511050 BACKGROUND

• 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.

  PMID: 29420423 BACKGROUND

• 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.

  PMID: 22980596 BACKGROUND

• 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.

  PMID: 12780901 BACKGROUND

• 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.

  PMID: 32003357 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Interventions

Pharmaceutical Preparations; Equipment and Supplies

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Fangyu Wang

CONTACT

+8613515100636; wangfy65@nju.edu.cn

Zhihao Ding

CONTACT

+8615061586037; d382428060@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Wang

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 7, 2022
• Study Start: May 30, 2022
• Primary Completion: September 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)