Second-degree HemorrhoidsNCT01383577
Comparison Between Single and Triple Rubber Band Ligation for the Treatment of Hemorrhoids
A study testing Single hemorrhoidal ligation and Triple hemorrhoidal ligation in people with Second-degree Hemorrhoids, run by Federal University of Amazonas at 1 site in Brazil.
Trial summary
Rubber band ligation is a widely adopted treatment of internal hemorrhoids in busy coloproctology institutions. All three major hemorrhoidal clusters (left lateral, right anterior and right posterior) use to be ligated in order to obtain therapeutic success. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Second-degree Hemorrhoids
- What is being tested?
- Single hemorrhoidal ligation and Triple hemorrhoidal ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Nov 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with second-degree hemorrhoids
Who cannot join
- Patients with special needs
- Immunodepression
- Indians
- Infectious, inflammatory or tumoral anorectal comorbidities
- Previous anorectal surgeries
- Patients on anticoagulant therapy or with coagulation disorders
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário Getúlio Vargas - Ambulatório Araújo Lima
Manaus, Amazonas, 69020-160
About this study
Official title: Double-blind Randomized Controlled Study of Single Versus Triple Rubber Band Ligation of Hemorrhoids
Rubber band ligation is a widely adopted treatment of internal hemorrhoids in busy coloproctology institutions. All three major hemorrhoidal clusters (left lateral, right anterior and right posterior) use to be ligated in order to obtain therapeutic success. It is commonly performed either through the ligation of a single hemorrhoid per session spaced by some few weeks to the second and third sessions, or of all three major hemorrhoids in one single session. Advocates of either method of hemorrhoidal ligation have arguments to defend their choice in terms of advantages, supported mainly on personal preferences. The investigators objective is to determine, through a controlled double-blinded randomized study, if there is any superiority of single hemorrhoidal ligation per session (in a total of three sessions) over the method of ligation of all three main hemorrhoids in a sole session in terms of therapeutic success (resolution of pre-ligation symptoms), morbidity, patient satisfaction and costs (institutional, labor and patient-related).
Read the detailed description
Because of conflicting results in existing literature in relation to features such as pain and immediate effectiveness of single or multiple rubber band ligation of hemorrhoids and because in the literature consulted no study was found that addressed economical features comparing single with multiple rubber band ligation of hemorrhoids, this study was designed to compare, in a double blinded, randomized and controlled model, the results of single hemorrhoidal ligation in three sessions with triple hemorrhoidal in a sole session in terms of immediate effectiveness, patient satisfaction and costs.
Patients enrolled in the study, after applying inclusion and exclusion criteria, signed the consent form, and responded to a questionaire about epidemiological data and hemorrhoidal symptoms, are (and will be) randomly allocated to one of the two arms of the study: G1: a single major hemorrhoidal group is ligated in each of three sessions of hemorrhoidal ligation, while the two other hemorrhoidal groups are submitted to sham ligation (a McGown aspirating type of hemorrhoidal ligator is employed); G2: all three major hemorrhoidal groups are ligated in the first session of treatment and in the next two sessions only sham ligations are performed. Three sessions of hemorrhoidal and/or sham ligation are performed in all patients, each spaced by one month from the other. A final consultation is held 1 month after the third ligation session in order to gather all the results of the treatment.
After each session of hemorrhoidal ligation patients receive a chart containing a modified level of pain scale (Wong \& Baker) and are asked to indicate pain level (from 0 to 5: 0 = no pain, 5 = unbearable pain) at fixed intervals (immediate post-ligation, 12 h post-ligation, 24 h post-ligation and each other day until 7 days post-ligation). Investigators gather this information about pain, and patient well-being post-ligations, from 8 programmed telephone calls to the patients after each session of hemorrhoidal (or sham) ligation.
Three months after the first session of hemorrhoidal ligation all patients are examined in order to observe treatment effectiveness and gather data about complications, patient satisfaction, number of days of occupational absenteeism linked to each session of treatment and number of analgesic pills necessary for pain relief.
Comparative costs of each modality of ligation are raised taking into consideration the salaries of health professionals involved in the treatment, the salaries of the patients (calculation of absenteeism), the value of consumables used in each session of effective ligation, the depreciation price of permanent material employed and the price of medications patients have to buy.
Patients are blinded to the modality of hemorrhoidal ligation employed and the statistician does not know the nature of each treatment group.
- Conditions
- Second-degree Hemorrhoids
- Being tested
- Single hemorrhoidal ligation, Triple hemorrhoidal ligation
- Keywords
- Hemorrhoids, Ligation, Pain, Morbidity, Patient Satisfaction, Cost-Benefit Analysis
- Medical subject headings
- Hemorrhoids, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single hemorrhoidal ligationProcedure or surgery
Also called Rubber band ligation of hemorrhoids, single
Effective ligation of one hemorrhoidal group and sham ligation of the two other major hemorrhoidal groups is performed in each of three sessions of treatment. Final revision is performed 90 days after first session of hemorrhoidal ligation.
Triple hemorrhoidal ligationProcedure or surgery
Also called Rubber band ligation of hemorrhoids, multiple
The three major hemorrhoidal groups are ligated in the first session of ligation. Sham triple hemorrhoidal ligations are performed 30 and 60 days after the first session. Final revision is done 90 days after first ligation session.
| Study group | Role | What they receive |
|---|---|---|
| Single hemorrhoidal ligation | Experimental | Effective ligation of one hemorrhoidal group and sham ligation of the two other major hemorrhoidal groups is performed in each session of treatment. Receives: Procedure: Single hemorrhoidal ligation |
| Triple hemorrhoidal ligation | Experimental | The three major hemorrhoidal groups are ligated in the first session of ligation. The three following monthly appointments of patients of this arm are for sham hemorrhoidal ligations and final revision. Receives: Procedure: Triple hemorrhoidal ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ligature-related pain intensity
Patients are asked to record pain intensity related to the hemorrhoidal ligation performed in a chart containing a modified pain intensity visual scale (Wong \& Baker). Investigators inquire patients about immediate pain sensation after a ligation session and at regular intervals, by telephone calls, until the 7th post-treatment day (12 h, 24 h, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day).
Measured: 7 days
Secondary outcomes (4)
Immediate complications
Complications eventually ocurring until 30 days of each session of rubber band ligation of hemorrhoids (effective or sham) are recorded by the investigators.
Measured: 30 days
Resolutive capacity of rubber band ligation of hemorrhoids
Resolution of pre-ligation hemorrhoidal symptoms is investigated 3 months after first session of rubber band ligation of hemorrhoids.
Measured: 90 days
Degree of patient satisfaction
Three months after first session (or single session, according to the arm of treatment) of rubber band hemorrhoidal ligation each patient degree of satisfaction with the method is recorded analogously using the modified visual pain scale of Wong \& Baker.
Measured: 90 days
Costs of each of the modes of ligation
Three months after the first rubber band ligation session, the costs involved in each treatment modality is raised. Calculations are done taking into account the value of the material employed in all the ligation sessions that are necessary to treat each individual patient, the value of the fraction of the investigators' salaries compromised in the treatment of each individual patient, how much each patient spends in pain medication and the value of the fraction of the patients' salaries involved in occupational absenteeism.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startMar 2010
- Primary completionFeb 2013
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second-degree 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Amazonas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Tramujas da Costa e Silva, Federal University of Amazonas
- Investigators
- Ivan T Costa e Silva, PhD, Principal investigator, Universidade Federal do AmazonasÉrico L Melo, Med Grad, Study chair, Universidade Federal do AmazonasGiselle L Afonso, Med Grad, Study chair, Universidade Federal do AmazonasFelicidad S Gimenez, MSc, Study chair, Universidade Federal do AmazonasShymmene O Cardoso, BAccount, Study chair, Universidade Federal do AmazonasDaniel Richard M Mota, Med Grad, Study chair, Universidade Federal do AmazonasRachel M Carvalho, Med Grad, Study chair, Universidade Federal do AmazonasSaskia Regina F Coppens, Med Grad, Study chair, Universidade Federal do Amazonas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383577
- Sponsor's protocol ID
- PP-S/0001/2010
- Status last verified
- Sep 2013
- First submitted
- 24 Jun 2011
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Controlled Study of Single Versus Triple Rubber Band Ligation of Hemorrhoids
- ClinicalTrials.gov ID
- NCT01383577
- Acronym / sponsor ID
- PP-S/0001/2010
- Conditions
- Second-degree Hemorrhoids
- Keywords
- Hemorrhoids, Ligation, Pain, Morbidity, Patient Satisfaction, Cost-Benefit Analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Federal University of AmazonasUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Nov 2013 (estimated)
- First posted
- 28 Jun 2011 (estimated)
- 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.
Rubber band ligation is a widely adopted treatment of internal hemorrhoids in busy coloproctology institutions. All three major hemorrhoidal clusters (left lateral, right anterior and right posterior) use to be ligated in order to obtain therapeutic success. It is commonly performed either through the ligation of a single hemorrhoid per session spaced by some few weeks to the second and third sessions, or of all three major hemorrhoids in one single session. Advocates of either method of hemorrhoidal ligation have arguments to defend their choice in terms of advantages, supported mainly on personal preferences. The investigators objective is to determine, through a controlled double-blinded randomized study, if there is any superiority of single hemorrhoidal ligation per session (in a total of three sessions) over the method of ligation of all three main hemorrhoids in a sole session in terms of therapeutic success (resolution of pre-ligation symptoms), morbidity, patient satisfaction and costs (institutional, labor and patient-related).
Detailed description
Because of conflicting results in existing literature in relation to features such as pain and immediate effectiveness of single or multiple rubber band ligation of hemorrhoids and because in the literature consulted no study was found that addressed economical features comparing single with multiple rubber band ligation of hemorrhoids, this study was designed to compare, in a double blinded, randomized and controlled model, the results of single hemorrhoidal ligation in three sessions with triple hemorrhoidal in a sole session in terms of immediate effectiveness, patient satisfaction and costs.
Patients enrolled in the study, after applying inclusion and exclusion criteria, signed the consent form, and responded to a questionaire about epidemiological data and hemorrhoidal symptoms, are (and will be) randomly allocated to one of the two arms of the study: G1: a single major hemorrhoidal group is ligated in each of three sessions of hemorrhoidal ligation, while the two other hemorrhoidal groups are submitted to sham ligation (a McGown aspirating type of hemorrhoidal ligator is employed); G2: all three major hemorrhoidal groups are ligated in the first session of treatment and in the next two sessions only sham ligations are performed. Three sessions of hemorrhoidal and/or sham ligation are performed in all patients, each spaced by one month from the other. A final consultation is held 1 month after the third ligation session in order to gather all the results of the treatment.
After each session of hemorrhoidal ligation patients receive a chart containing a modified level of pain scale (Wong \& Baker) and are asked to indicate pain level (from 0 to 5: 0 = no pain, 5 = unbearable pain) at fixed intervals (immediate post-ligation, 12 h post-ligation, 24 h post-ligation and each other day until 7 days post-ligation). Investigators gather this information about pain, and patient well-being post-ligations, from 8 programmed telephone calls to the patients after each session of hemorrhoidal (or sham) ligation.
Three months after the first session of hemorrhoidal ligation all patients are examined in order to observe treatment effectiveness and gather data about complications, patient satisfaction, number of days of occupational absenteeism linked to each session of treatment and number of analgesic pills necessary for pain relief.
Comparative costs of each modality of ligation are raised taking into consideration the salaries of health professionals involved in the treatment, the salaries of the patients (calculation of absenteeism), the value of consumables used in each session of effective ligation, the depreciation price of permanent material employed and the price of medications patients have to buy.
Patients are blinded to the modality of hemorrhoidal ligation employed and the statistician does not know the nature of each treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single hemorrhoidal ligation | Experimental | Procedure: Single hemorrhoidal ligationEffective ligation of one hemorrhoidal group and sham ligation of the two other major hemorrhoidal groups is performed in each session of treatment. |
| Triple hemorrhoidal ligation | Experimental | Procedure: Triple hemorrhoidal ligationThe three major hemorrhoidal groups are ligated in the first session of ligation. The three following monthly appointments of patients of this arm are for sham hemorrhoidal ligations and final revision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with second-degree hemorrhoids
Key exclusion criteria (6 listed)
- Patients with special needs
- Immunodepression
- Indians
- Infectious, inflammatory or tumoral anorectal comorbidities
- Previous anorectal surgeries
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 |
|---|---|---|
| Single hemorrhoidal ligationAlso: Rubber band ligation of hemorrhoids, singleEffective ligation of one hemorrhoidal group and sham ligation of the two other major hemorrhoidal groups is performed in each of three sessions of treatment. Final revision is performed 90 days after first session of hemorrhoidal ligation. | Procedure or surgery | Single hemorrhoidal ligation |
| Triple hemorrhoidal ligationAlso: Rubber band ligation of hemorrhoids, multipleThe three major hemorrhoidal groups are ligated in the first session of ligation. Sham triple hemorrhoidal ligations are performed 30 and 60 days after the first session. Final revision is done 90 days after first ligation session. | Procedure or surgery | Triple hemorrhoidal ligation |
Primary outcome
Ligature-related pain intensity
Time frame: 7 days
Patients are asked to record pain intensity related to the hemorrhoidal ligation performed in a chart containing a modified pain intensity visual scale (Wong \& Baker). Investigators inquire patients about immediate pain sensation after a ligation session and at regular intervals, by telephone calls, until the 7th post-treatment day (12 h, 24 h, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day).
4 secondary outcomes
Immediate complications
Time frame: 30 days
Resolutive capacity of rubber band ligation of hemorrhoids
Time frame: 90 days
Degree of patient satisfaction
Time frame: 90 days
Costs of each of the modes of ligation
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
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Traditional Medicine Syndromes in Internal Hemorrhoids: a Cross-Sectional Study
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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.
Ivan T Costa e Silva, PhD principal investigator
Universidade Federal do Amazonas
Érico L Melo, Med Grad study chair
Universidade Federal do Amazonas
Giselle L Afonso, Med Grad study chair
Universidade Federal do Amazonas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single hemorrhoidal ligation and Triple hemorrhoidal ligation in people with Second-degree Hemorrhoids, run by Federal University of Amazonas at 1 site in Brazil.
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 1 inclusion and 6 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 26 Sep 2013. 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 Brazil. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ligature-related pain intensity (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2013.