Clinical trial NCT05089500: The Two Treatment Methods Compared the Sclerosing Agent Injection and the Rubber Wrapping
Official title: A Prospective Multicenter Clinical Study of a Soft Endoscopic Treatment Protocol for Internal Hemorrhoid at Degree I-Ⅲ.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoid
Hemorrhoids
Hemorrhoids Internal
Hemorrhoid Prolapse
Hemorrhoid Bleeding
Hemorrhoid Pain
Keywords: Endoscopic injection sclerotherapy
Endoscopic Band Ligation
Hemorrhoids
Hemorrhoid
Soft Endoscopy
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
Collaborators: name: Zhejiang University
name: The First Affiliated Hospital of Nanchang University
name: Army Military Medical University Southwestern Hospital
name: Shanxi Provincial Coal Central Hospital
name: Hubei Hospital of Traditional Chinese Medicine
name: Wuhan Puren Hospital
name: Wuhan Tianyou Hospital
name: Hanyang University
name: Enshi State Central Hospital
name: Yichang Central People's Hospital
name: Central Hospital of Xiaogan
name: Xiaogan City First People's Hospital
name: Fuyang City Second People's Hospital
name: Chibi City People's Hospital
First posted: 2021-10-22
Enrollment: 984
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: Inclusion 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:

1. Age \<18 or age\> 75;
2. External hemorrhoids or mixed hemorrhoids;
3. degree Ⅳ 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.

Primary outcomes:
measure: recurernce rate
timeFrame: 12 months
Secondary outcomes:
measure: Postoperative complications and adverse events
timeFrame: 12 months
measure: Surgical costs
timeFrame: 12 months
measure: Health-related QIL score
timeFrame: 12 months
measure: Patient satisfaction survey
timeFrame: 12 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Mingkai Chen
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Mingkai Chen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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. Epub 2015 Nov 7.
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;149(7):1731-1741.e3. doi: 10.1053/j.gastro.2015.08.045. Epub 2015 Aug 29.
citation: Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation. An epidemiologic study. Gastroenterology. 1990 Feb;98(2):380-6. doi: 10.1016/0016-5085(90)90828-o.
citation: 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.
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 17.
citation: Higuero T, Abramowitz L, Castinel A, Fathallah N, Hemery P, Laclotte Duhoux C, Pigot F, Pillant-Le Moult H, Senejoux A, Siproudhis L, Staumont G, Suduca JM, Vinson-Bonnet B. Guidelines for the treatment of hemorrhoids (short report). J Visc Surg. 2016 Jun;153(3):213-8. doi: 10.1016/j.jviscsurg.2016.03.004. Epub 2016 May 18.
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. No abstract available.
citation: 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.
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.
citation: Rorvik 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 Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.