HemorrhoidsNCT02851940
Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids
A study testing Rubber Band Ligation and Hypertonic Saline Infusion in people with Hemorrhoids and Bleeding, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The investigators aim at prospectively comparing procedural pain, adverse events and rebleeding rates of anoscopic rubber band ligation and endoscopic hypertonic saline injection in patients with symptomatic hemorrhoidal disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhoids, Bleeding, Pain
- What is being tested?
- Rubber Band Ligation and Hypertonic Saline Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteLebanon
- Study dates
- Sep 2016to Jan 2018
- 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
- Age 18+
- Consent to the study
- Bleeding grade 1,2 and 3 hemorrhoids
Who cannot join
- Age under 18 years
- Refusal to sign consent
- Prior surgical and non surgical hemorrhoid procedure/manipulation
- External hemorrhoids
- Thrombosed hemorrhoids
- Active Anal Fissure
Show all 11Show fewer
- Active anal fistula
- Immunocompromised
- Grade 4 internal hemorrhoids
- Chronic Pain requiring analgesics
- Antiplatelets and anticoagulation intake other than Aspirin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids: A Randomized Prospective Study
The investigators aim at prospectively comparing procedural pain, adverse events and rebleeding rates of anoscopic rubber band ligation and endoscopic hypertonic saline injection in patients with symptomatic hemorrhoidal disease
Read the detailed description
Hemorrhoidal disease is a common encounter in a gastroenterologist's practice. These are often symptomatic, either bleeding or prolapsing. There are no set guidelines in our institution (The American University of Beirut Medical Center - AUBMC) for the treatment of symptomatic hemorrhoidal disease. Two types of treatment are available at our institution: anoscopic rubber band ligation (RBL) or endoscopic sclerotherapy (ESC) with hypertonic (20%) saline. Both methods have been shown to be effective in the literature, with above 75% complete symptomatic relief from a single application after 8-12 months. Post procedural pain of RBL in two randomized studies ranged 40-47%, while different studies showed post procedural pain following ESC to be 12-39%. However no study has ever compared these two therapeutic methods head-on, neither has any study compared both procedures for tolerability and rebleeding rates.
Research design and methods:
This study is a randomized, prospective study conducted at the American University of Beirut Medical Center which will involve 30 patients suffering from symptomatic hemorrhoidal disease requiring therapeutic intervention. Patients meeting inclusion criteria will be randomized using a computer generated randomization list to either Rubber Band Ligation (RBL) or Hypertonic Saline Sclerotherapy as a therapeutic interventional procedure.
- Patients will be approached by their Gastroenterologist during clinic visits and informed about the study. If participants wish to take part in the study, they will be given additional study information, screened for inclusion criteria, and consented by the research assistant or clinic nurse. Recruitment and randomization will occur during the same visit after patient consent in order to properly schedule patients for their therapeutic interventional procedures. All rubber band ligations will be performed by one endoscopist and all sclerotherapies will be performed by the other endoscopist.
- Conditions
- Hemorrhoids, Bleeding, Pain
- Being tested
- Rubber Band Ligation, Hypertonic Saline Infusion
- Keywords
- Pain, Bleeding, Hemorrhoids, Band Ligation, hypertonic saline sclerotherapy
- Medical subject headings
- Hemorrhoids, Hemorrhage, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubber Band LigationProcedure or surgery
Anoscopic rubber band ligation by bedside with patient in the jack-knife position (equipment: anoscope, rubber band applicator)
Hypertonic Saline InfusionProcedure or surgery
Endoscopic retroflexed 3 ml injection of 20% hypertonic saline 1cm above the dentate line (equipment: Flex sig, injection needle, 20% saline)
| Study group | Role | What they receive |
|---|---|---|
| A (Rubber Band Ligation) | Experimental | 15 patients Receives: Procedure: Rubber Band Ligation |
| B (Hypertonic Saline Infusion) | Experimental | 15 patients Receives: Procedure: Hypertonic Saline Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Pain Score
Range 0 (no pain) to 10 (maximum pain)
Measured: Days 0 after procedure
Composite Pain Score
Range 0 (no pain) to 10 (maximum pain)
Measured: Day 3 after procedure
Composite Pain Score
Range 0 (no pain) to 10 (maximum pain)
Measured: Day 7 after procedure
Secondary outcomes (4)
Bleeding
If any bleeding is noticed upon defecation
Measured: Days 1 to 7 after the procedure
Pain Medication Usage
Measured: Days 1 to 7 after the procedure
Bleeding
If any bleeding is noticed upon defecation
Measured: week 1-week 7 post procedure, 3 months, 6 months
Pain
Range 0 (no pain) to 10 (maximum pain)
Measured: week 1-week 7 post procedure, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: No patients recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ala I Sharara, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851940
- Sponsor's protocol ID
- IM.FD.04
- Status last verified
- May 2016
- First submitted
- 26 Jul 2016
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In the publication
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT02851940
- Acronym / sponsor ID
- IM.FD.04
- Conditions
- Hemorrhoids, Bleeding, Pain
- Keywords
- Pain, Bleeding, Hemorrhoids, Band Ligation, hypertonic saline sclerotherapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 2 Aug 2016 (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.
The investigators aim at prospectively comparing procedural pain, adverse events and rebleeding rates of anoscopic rubber band ligation and endoscopic hypertonic saline injection in patients with symptomatic hemorrhoidal disease
Detailed description
Hemorrhoidal disease is a common encounter in a gastroenterologist's practice. These are often symptomatic, either bleeding or prolapsing. There are no set guidelines in our institution (The American University of Beirut Medical Center - AUBMC) for the treatment of symptomatic hemorrhoidal disease. Two types of treatment are available at our institution: anoscopic rubber band ligation (RBL) or endoscopic sclerotherapy (ESC) with hypertonic (20%) saline. Both methods have been shown to be effective in the literature, with above 75% complete symptomatic relief from a single application after 8-12 months. Post procedural pain of RBL in two randomized studies ranged 40-47%, while different studies showed post procedural pain following ESC to be 12-39%. However no study has ever compared these two therapeutic methods head-on, neither has any study compared both procedures for tolerability and rebleeding rates.
Research design and methods:
This study is a randomized, prospective study conducted at the American University of Beirut Medical Center which will involve 30 patients suffering from symptomatic hemorrhoidal disease requiring therapeutic intervention. Patients meeting inclusion criteria will be randomized using a computer generated randomization list to either Rubber Band Ligation (RBL) or Hypertonic Saline Sclerotherapy as a therapeutic interventional procedure.
- Patients will be approached by their Gastroenterologist during clinic visits and informed about the study. If participants wish to take part in the study, they will be given additional study information, screened for inclusion criteria, and consented by the research assistant or clinic nurse. Recruitment and randomization will occur during the same visit after patient consent in order to properly schedule patients for their therapeutic interventional procedures. All rubber band ligations will be performed by one endoscopist and all sclerotherapies will be performed by the other endoscopist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (Rubber Band Ligation) | Experimental | Procedure: Rubber Band Ligation15 patients |
| B (Hypertonic Saline Infusion) | Experimental | Procedure: Hypertonic Saline Infusion15 patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18+
- Consent to the study
- Bleeding grade 1,2 and 3 hemorrhoids
Key exclusion criteria (11 listed)
- Age under 18 years
- Refusal to sign consent
- Prior surgical and non surgical hemorrhoid procedure/manipulation
- External hemorrhoids
- Thrombosed 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 |
|---|---|---|
| Rubber Band LigationAnoscopic rubber band ligation by bedside with patient in the jack-knife position (equipment: anoscope, rubber band applicator) | Procedure or surgery | A (Rubber Band Ligation) |
| Hypertonic Saline InfusionEndoscopic retroflexed 3 ml injection of 20% hypertonic saline 1cm above the dentate line (equipment: Flex sig, injection needle, 20% saline) | Procedure or surgery | B (Hypertonic Saline Infusion) |
Primary outcome
Composite Pain Score
Time frame: Days 0 after procedure
Range 0 (no pain) to 10 (maximum pain)
Composite Pain Score
Time frame: Day 3 after procedure
Range 0 (no pain) to 10 (maximum pain)
Composite Pain Score
Time frame: Day 7 after procedure
Range 0 (no pain) to 10 (maximum pain)
4 secondary outcomes
Bleeding
Time frame: Days 1 to 7 after the procedure
Pain Medication Usage
Time frame: Days 1 to 7 after the procedure
Bleeding
Time frame: week 1-week 7 post procedure, 3 months, 6 months
Pain
Time frame: week 1-week 7 post procedure, 3 months, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Yes. In the publication
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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.
Ala I Sharara, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rubber Band Ligation and Hypertonic Saline Infusion in people with Hemorrhoids and Bleeding, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 31 Jan 2024. 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 Lebanon. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Composite Pain Score (time frame: Days 0 after procedure). The study lists 3 primary outcomes in all. 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 31 Jan 2024.