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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
| Wuhan Puren Hospital | OTHER |
| Yichang Central People's Hospital |
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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-ā ¢ 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
Continuous recruitment of symptomatic internal hemorrhoid patients who visited the main center and sub centers was conducted using a stratified block randomization method, with a 1:1 random allocation to the endoscopic injection sclerotherapy group and endoscopic band ligation group for intervention. During the perioperative period, demographic characteristics, intraoperative conditions, postoperative complications and surgery related costs, length of hospital stay were recorded, and HDSS, EQ-5D-5L, EQ-VAS scores were recorded. Changes in scores were recorded during telephone follow-up at 2 weeks, 3 months, and 12 months after surgery, as well as whether the patient's symptoms improved, recurred, and satisfaction was assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic injection sclerotherapy | Experimental |
| |
| Endoscopic Band Ligation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic injection sclerotherapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| recurernce rate | After treatment, the recurrence of internal hemorrhoids symptoms | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications and adverse events | Patients from complications and adverse events following intervention (postoperative bleeding, anal distension, pain, urinary retention and others) | Postoperative and follow-up periods |
| early symptom relief rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mingkai Chen, M.D | Renmin Hospital of Wuhan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mingkai Chen | Wuhan | Hubei | 430060 | China | ||
| Renmin Hospital of Wuhan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26547759 | Result | 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. | |
| 26327134 | Result | 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. |
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| OTHER |
| Fuyang Second People's Hospital | UNKNOWN |
| Hubei Hospital of Traditional Chinese Medicine | OTHER |
| Shanxi Provincial Fifth People's Hospital | UNKNOWN |
| The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture | OTHER |
| Jingzhou First People's Hospital | UNKNOWN |
| Chibi People's Hospital | UNKNOWN |
| Tianyou Hospital Affiliated to Wuhan University of Science and Technology | OTHER |
| Central Hospital of Xiaogan | OTHER |
| Xiaogan First People's Hospital | UNKNOWN |
| The First Affiliated Hospital of Army Medical University (Southwest Hospital) | UNKNOWN |
| Wuhan University of Science and Technology Affiliated Hanyang Hospital | UNKNOWN |
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| Endoscopic Band Ligation | Other | 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. |
|
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self-rated improvement postoperative 2 weeks and 3 months |
| 2 weeks and 3 months after surgery |
| HDSS | Hemorrhoid Disease Symptom Scoreļ¼ scale 0-20, high score means better | 2 week, 3 month, 12 month after surgery |
| EQ-5D-5L | the European Quality of Life 5-Dimensions 5-Levels questionnaire, scale -1 ~ 1, high scores means better outcome | 2 week, 3 month, 12 month after surgery |
| EQ-VAS | the European Quality of visual analogue scale, scale 0-100, high value means better | 2 week, 3 month, 12 month after surgery |
| Surgical costs | Cost of treatment | After surgery |
| Patient satisfaction survey | Patient satisfaction evaluation of the treatment method | 3 months or 12 months after surgery |
| Wuhan |
| Hubei |
| 430060 |
| China |
| 2295392 | Result | 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. |
| 30998519 | Result | 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. |
| 32067353 | Result | 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. |
| 27209079 | Result | 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. |
| 29420423 | Result | 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 | Result | 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. |
| 31057696 | Result | 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. |
| 30451751 | Result | 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. |
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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