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| Name | Class |
|---|---|
| The Second Hospital of Nanjing Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| performing endoscopy | Other | Hemorrhoids will be treated by endoscopic sclerotherapy or endoscopic rubber band ligation or endoscopic sclerotherapy combined with rubber band ligation |
| 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 treatmentï¼›Cure rate refers to the percentage of symptoms that completely disappear. | one year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fangyu Wang | Contact | +8613515100636 | wangfy65@nju.edu.cn | |
| Zhihao Ding | Contact | +8615061586037 | d382428060@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling hospital | Nanjing | Jiangsu | 210002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31583307 | Background | 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. | |
| 15131807 | 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. |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D004864 | Equipment and Supplies |
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| 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 |
| 33511050 | 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. |
| 29420423 | 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. |
| 22980596 | 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. |
| 12780901 | 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. |
| 32003357 | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |