The Two Treatment Methods Compared the Sclerosing Agent Injection and the Rubber Wrapping
NCT ID: NCT05089500
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
984 participants
INTERVENTIONAL
2021-11-01
2023-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endoscopic injection sclerotherapy
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
Yes
Sponsors
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Zhejiang University
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Army Military Medical University Southwestern Hospital
UNKNOWN
Shanxi Provincial Coal Central Hospital
UNKNOWN
Hubei Hospital of Traditional Chinese Medicine
OTHER
Wuhan Puren Hospital
OTHER
Wuhan Tianyou Hospital
UNKNOWN
Hanyang University
OTHER
Enshi State Central Hospital
UNKNOWN
Yichang Central People's Hospital
OTHER
Central Hospital of Xiaogan
OTHER
Xiaogan City First People's Hospital
UNKNOWN
Fuyang City Second People's Hospital
UNKNOWN
Chibi City People's Hospital
UNKNOWN
Renmin Hospital of Wuhan University
OTHER
Responsible Party
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ChenMingkai
Professor
Principal Investigators
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Mingkai Chen, M.D
Role: PRINCIPAL_INVESTIGATOR
Renmin Hospital of Wuhan University
Locations
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Mingkai Chen
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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WDRY2021-K131
Identifier Type: -
Identifier Source: org_study_id