HemorrhoidsNCT05268575
A Study on the Endoscopic Treatments of Hemorrhoids
A study testing performing endoscopy in people with Hemorrhoids, run by Fangyu Wang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- performing endoscopy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent form.
- Age 18-80 years with clinical symptoms of hemorrhoids.
- Subjects able to follow the follow-up schedule, able to describe symptoms objectively and able to cooperate in completing the scale.
- non-breastfeeding pregnant women and those with no pregnancy planned during the trial
- not participating in various clinical trials in the 3 months prior to and during the trial
- Not taking long-term anticoagulant drugs (e.g., clopidogrel, aspirin, triptans, etc.) or have stopped taking them for 5-7 days.
Who cannot join
- those with severe organ insufficiency of the heart, brain, lungs and kidneys
- those who cannot tolerate endoscopic treatment
- those with severe coagulation disorders
- men with a history of severe prostate enlargement
- with severe intestinal diseases: colon malignancy, ulcerative colitis, Crohn's disease, anal fistula, anal fissure, acute thrombosed internal hemorrhoids
- those who are allergic to sclerosing agents
- Those who, in the opinion of the investigator, cannot be enrolled for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study on Endoscopic Treatments for Hemorrhoids (METHOD): a Multicenter, Randomized Controlled Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Hemorrhoids
- Being tested
- performing endoscopy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
performing endoscopyOther
Also called drugs, device
Hemorrhoids will be treated by endoscopic sclerotherapy or endoscopic rubber band ligation or endoscopic sclerotherapy combined with rubber band ligation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: performing endoscopy |
| 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. Receives: Other: performing endoscopy |
| 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. Receives: Other: performing endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total effective rate
Total effective rate includes effective rate and cure rate. Effective rate means that symptoms are better than before treatment；Cure rate refers to the percentage of symptoms that completely disappear.
Measured: one year
Secondary outcomes (9)
Incidence of complications
Incidence of complications such as urinary retention, anal stricture, etc. within 1 year
Measured: 1 year
Incidence of new symptoms
Incidence of new symptoms such as bleeding, pain, etc. within 1 year
Measured: 1 year
Recurrence rate after treatment
Recurrence rate after 1 year of treatment
Measured: 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.
Measured: 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)
Measured: 1 year
Intraoperative situation
The amount of intraoperative bleeding and whether the patient had discomfort during the operation.
Measured: 1 year
Number of days in hospital
Number of days in hospital
Measured: 1 year
Hospitalization Costs
Hospitalization Costs
Measured: 1 year
Incidence of needing re-treatment
Need for retreatment due to recurrence or worsening of symptoms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start30 May 2022 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fangyu Wang
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Nanjing Medical University
- Responsible party
- Sponsor-investigator, Fangyu Wang, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268575
- Sponsor's protocol ID
- DZQH-KYLLSL-21-15
- Status last verified
- Apr 2022
- First submitted
- 10 Feb 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31583307Madoff 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.
PubMed 15131807Ma 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.
PubMed 33511050Davis 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.
PubMed 29420423Awad 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.
PubMed 22980596Kanellos 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.
PubMed 12780901Abiodun 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.
PubMed 32003357
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on Endoscopic Treatments for Hemorrhoids (METHOD): a Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05268575
- Acronym / sponsor ID
- DZQH-KYLLSL-21-15
- Conditions
- Hemorrhoids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Fangyu WangUniversity, hospital or other
- Collaborators
- The Second Hospital of Nanjing Medical University
- Study start
- 30 May 2022 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| endoscopic sclerotherapy | Experimental | Other: performing endoscopyPatients 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. |
| endoscopic rubber band ligation | Experimental | Other: performing endoscopyPatients 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 | Other: performing endoscopyPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sign a written informed consent form.
- Age 18-80 years with clinical symptoms of hemorrhoids.
- Subjects able to follow the follow-up schedule, able to describe symptoms objectively and able to cooperate in completing the scale.
- non-breastfeeding pregnant women and those with no pregnancy planned during the trial
- not participating in various clinical trials in the 3 months prior to and during the trial
Key exclusion criteria (7 listed)
- those with severe organ insufficiency of the heart, brain, lungs and kidneys
- those who cannot tolerate endoscopic treatment
- those with severe coagulation disorders
- men with a history of severe prostate enlargement
- with severe intestinal diseases: colon malignancy, ulcerative colitis, Crohn's disease, anal fistula, anal fissure, acute thrombosed internal hemorrhoids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| performing endoscopyAlso: drugs, deviceHemorrhoids will be treated by endoscopic sclerotherapy or endoscopic rubber band ligation or endoscopic sclerotherapy combined with rubber band ligation | Other | endoscopic rubber band ligation, endoscopic sclerotherapy, endoscopic sclerotherapy combined with rubber band ligation |
Primary outcome
Total effective rate
Time frame: one year
Total effective rate includes effective rate and cure rate. Effective rate means that symptoms are better than before treatment；Cure rate refers to the percentage of symptoms that completely disappear.
9 secondary outcomes
Incidence of complications
Time frame: 1 year
Incidence of new symptoms
Time frame: 1 year
Recurrence rate after treatment
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
Endoscopic presentation of hemorrhoids
Time frame: 1 year
Intraoperative situation
Time frame: 1 year
Number of days in hospital
Time frame: 1 year
Hospitalization Costs
Time frame: 1 year
Incidence of needing re-treatment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Background: PubMed 31583307Yamana 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.
- Background: PubMed 15131807Madoff 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.
- Background: PubMed 33511050Ma 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.
- Background: PubMed 29420423Davis 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.
- Background: PubMed 22980596Awad 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.
- Background: PubMed 12780901Kanellos 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.
- Background: PubMed 32003357Abiodun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing performing endoscopy in people with Hemorrhoids, run by Fangyu Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangyu Wang (+8613515100636, wangfy65@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total effective rate (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05268575, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.