The Two Treatment Methods Compared the Sclerosing Agent Injection and the Rubber Wrapping

Hemorrhoids Clinical Trial

Official title:

A Prospective Multicenter Clinical Study of a Soft Endoscopic Treatment Protocol for Internal Hemorrhoid at Degree I-Ⅲ.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05089500
• Other study ID #: WDRY2021-K131
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2021
• Source: Renmin Hospital of Wuhan University
• Contact: Mingkai Chen, M.D
• Phone: 0086-13720330580
• Email: kaimingchen[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, multicentre, and randomized-controlled clinical study.The researchers wanted to explore the optimal treatment regimen for soft hemorrhoid within I-Ⅲ degrees by evaluating and comparing the effectiveness, safety and cost effect ratio of sclerosing injection and rubber lap ligation in patients with different internal hemorrhoid scores

Description:

From November 2021 to July 2022, patients with internal hemorrhoids seeking treatment were enrolled according to the following criteria: 1. Age 18 to 75, men and women; 2. Patients with clinical symptoms of degree I-Ⅲ internal hemorrhoids confirmed after medical history collection, clinical examination or colonoscopy; 3. The patient was willing to receive minimally invasive treatment for internal hemorrhoids and sign informed consent by himself or his legal agent. Exclusion criteria are as follows: 1. age <18 or> 75; 2. External hemorrhoids or mixed hemorrhoids; 3. Ⅳ degree of hemorrhoid 4. Unsymptomatic internal hemorrhoids; 5. Internal hemorrhoids were combined with complications such as chimerism, thrombosis, ulceration, or infection; 6. Poor basic conditions can not tolerate endoscopic treatment, such as serious cardiovascular and cerebrovascular diseases, respiratory dysfunction, liver and kidney failure, mental disorders, etc.; 7. There are other serious diseases involving the rectum and anus, such as anal fistula, perianal infection, anal stenosis, inflammatory bowel disease activity period, colorectal tumors, etc.; 8. Patients with severe coagulation dysfunction or long-term oral anticoagulant drugs or antiplatelet aggregation drugs without withdrawal; 9. Women in pregnancy or puerperium; 10. Sclerotic with allergy patient , such as polycininol, etc; 11. Previous history of endoscopic treatment of hemorrhoid disease, surgical history or other low rectal and anal surgery history; 12. The patient was unwilling to receive endoscopic treatment for internal hemorrhoids, and himself or his legal agent refused to sign the informed consent form.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 984
• Est. completion date: September 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18 to 75, men and women;

2. Patients with clinical symptoms of degree I-? internal hemorrhoids confirmed after medical history collection, clinical examination or colonoscopy;

3. The patient was willing to receive minimally invasive treatment for internal hemorrhoids and sign informed consent by himself or his legal agent.

Exclusion Criteria:

1. Age <18 or age> 75;

2. External hemorrhoids or mixed hemorrhoids;

3. degree ? internal hemorrhoids

4. Unsymptomatic internal hemorrhoids

5. Internal hemorrhoids were combined with complications such as chimerism, thrombosis, ulceration, or infection;

6. Poor basic conditions can not tolerate endoscopic treatment, such as serious cardiovascular and cerebrovascular diseases, respiratory dysfunction, liver and kidney failure, mental disorders, etc.;

7. There are other serious diseases involving the rectum and anus, such as anal fistula, perianal infection, anal stenosis, inflammatory bowel disease activity period, colorectal tumors, etc.;

8. Patients with severe coagulation dysfunction or long-term oral anticoagulant drugs or antiplatelet aggregation drugs without withdrawal;

9. Women in pregnancy or puerperium;

10. Hardening agent allergy patients, such as polycininol, etc;

11. Previous history of endoscopic treatment of hemorrhoid disease, surgical history or other low rectal and anal surgery history;

12. The patient was unwilling to receive endoscopic treatment for internal hemorrhoids, and himself or his legal agent refused to sign the informed consent form.

Related Conditions & MeSH terms

• Hemorrhoid
• Hemorrhoid Bleeding
• Hemorrhoid Pain
• Hemorrhoids
• Prolapse

Intervention

Other:
• Endoscopic injection sclerotherapy
Patients were randomized assigned to the EIS group, preparing disposable endoscopic injections and sclerosing which were routinely administered with 1% polycinol.The transparent cap was fixed at the front end of the endoscope in inverted or orthofield of view.The stiffening agent or foam stiffer added to Meilan was injected with a disposable injection needle at 4-6 points at the oral end near the dentate line. Each point contained 0.2-1ml, and stopped after the hemorrhoid nucleus changed color. If necessary, a transparent cap was pressed to stop the bleeding to distribute the stiffening agent evenly.
• Endoscopic Band Ligation
Patients were randomized assigned to the EBL group and were to be prepared before surgery.After the socket is mounted at the inner lens end, the socket is obviously tied at 1-2cm hemorrhoids at the mouth above the dentate line, usually 2-4 rings.With mucosal prolapse, pericyclic multiple dislocation ligation can be performed 2-3cm above the obvious prolapse.

Locations

Country	Name	City	State
China	Mingkai Chen	Wuhan	Hubei
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (15)

Lead Sponsor

Collaborator

Renmin Hospital of Wuhan University

Army Military Medical University Southwestern Hospital, Chibi City People's Hospital, Enshi State Central Hospital, Fuyang City Second People's Hospital, Hubei Hospital of Traditional Chinese Medicine, Shanxi Provincial Coal Central Hospital, The First Affiliated Hospital of Nanchang University, Wuhan Hanyang Hospital, Wuhan Puren Hospital, Wuhan Tianyou Hospital, Xiaogan City Central Hospital, Xiaogan City First People's Hospital, Yichang City Central People's Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (10)

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Cosman BC. Piles of Money: "Hemorrhoids" Are a Billion-Dollar Industry. Am J Gastroenterol. 2019 May;114(5):716-717. doi: 10.14309/ajg.0000000000000234. — View Citation

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. — View Citation

Elbetti C, Giani I, Novelli E, Fucini C, Martellucci J. The single pile classification: a new tool for the classification of haemorrhoidal disease and the comparison of treatment results. Updates Surg. 2015 Dec;67(4):421-6. doi: 10.1007/s13304-015-0333-0. — View Citation

Higuero T, Abramowitz L, Castinel A, Fathallah N, Hemery P, Laclotte Duhoux C, Pigot F, Pillant-Le Moult H, Senéjoux A, Siproudhis L, Staumont G, Suduca JM, Vinson-Bonnet B. Guidelines for the treatment of hemorrhoids (short report). J Visc Surg. 2016 Jun — View Citation

Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation. An epidemiologic study. Gastroenterology. 1990 Feb;98(2):380-6. — View Citation

Peery AF, Crockett SD, Barritt AS, Dellon ES, Eluri S, Gangarosa LM, Jensen ET, Lund JL, Pasricha S, Runge T, Schmidt M, Shaheen NJ, Sandler RS. Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States. Gastroenterology. 2015 Dec;14 — View Citation

Rørvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rec — View Citation

Rubbini M, Ascanelli S. Classification and guidelines of hemorrhoidal disease: Present and future. World J Gastrointest Surg. 2019 Mar 27;11(3):117-121. doi: 10.4240/wjgs.v11.i3.117. — View Citation

van Tol RR, Kleijnen J, Watson AJM, Jongen J, Altomare DF, Qvist N, Higuero T, Muris JWM, Breukink SO. European Society of ColoProctology: guideline for haemorrhoidal disease. Colorectal Dis. 2020 Jun;22(6):650-662. doi: 10.1111/codi.14975. Epub 2020 Feb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurernce rate	After treatment, the recurrence of internal hemorrhoids symptoms (based on Goligher score and HDSS symptom score)	12 months
Secondary	Postoperative complications and adverse events	Patients from complications and serious adverse events following intervention	12 months
Secondary	Surgical costs	Cost of treatment	12 months
Secondary	Health-related QIL score	Assessment of patient quality of life after surgery	12 months
Secondary	Patient satisfaction survey	Patient satisfaction evaluation of the treatment method	12 months