HemorrhoidsNCT00630669
Comparison Between Two Endoscopic Treatments of Bleeding Internal Hemorrhoids:Band Ligation and Electrocoagulation Probe
A study testing Rubber band ligation and Bipolar coagulation in people with Hemorrhoids, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to determine which treatment, band ligation (placing rubber bands around the hemorrhoids) or BICAP electrocoagulation (using electricity to cauterize) is safer and more effective endoscopic treatment for bleeding internal hemorrhoids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Rubber band ligation and Bipolar coagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1997to May 2001
- 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
- Grade II or III internal hemorrhoids with chronic rectal bleeding, which failed at least 8 weeks of intensive medical therapy.
- Age over 18 years
- A life expectancy of at least 24 months
- A signed written informed consent
Who cannot join
- The patient was uncooperative or could not return for routine outpatient follow-up
- Severe or end-stage co-morbid illness
- Prior endoscopic or surgical treatment of hemorrhoids within the past 6 months
- Ongoing need for anticoagulation therapy or high doses of aspirin or non-steroidal antiinflammatory agents
- Presence of severe rectal pain
- Recently thrombosed internal or external hemorrhoids
Show all 14Show fewer
- Anal stricture,fissure, fistula,or abscess
- Rectal carcinoma or bleeding distal colonic polyp
- Rectal varices
- Acute or chronic colitis
- Rectal prolapse
- Radiation telangiectasia of the rectum
- Prothrombin time >3 seconds over control
- Platelet count <75,000
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Of Endoscopic Band Ligation Versus Bipolar Probe Electrocoagulation Of Bleeding Internal Hemorrhoids
The purpose of this study is to determine which treatment, band ligation (placing rubber bands around the hemorrhoids) or BICAP electrocoagulation (using electricity to cauterize) is safer and more effective endoscopic treatment for bleeding internal hemorrhoids.
- Conditions
- Hemorrhoids
- Being tested
- Rubber band ligation, Bipolar coagulation
- Keywords
- Internal hemorrhoids, Rubber band ligation, Bipolar coagulation
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubber band ligationProcedure or surgery
placing rubber bands around the internal hemorrhoids
Bipolar coagulationProcedure or surgery
using electricity to cauterize
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Rubber band ligation Receives: Procedure: Rubber band ligation |
| 2 | Active comparator | Bipolar coagulation Receives: Procedure: Bipolar coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment success rate
Measured: one year
Secondary outcomes (1)
treatment complication rate
Measured: one 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 2008 (estimated)
- Study startDec 1997
- Primary completionMay 2000
- Study completionMay 2001
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.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630669
- Sponsor's protocol ID
- 97-10-009-03
- Status last verified
- May 2001
- First submitted
- 27 Feb 2008
- Last updated
- 7 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Of Endoscopic Band Ligation Versus Bipolar Probe Electrocoagulation Of Bleeding Internal Hemorrhoids
- ClinicalTrials.gov ID
- NCT00630669
- Acronym / sponsor ID
- 97-10-009-03
- Conditions
- Hemorrhoids
- Keywords
- Internal hemorrhoids, Rubber band ligation, Bipolar coagulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Study start
- Dec 1997
- Primary completion
- May 2000 (actual)
- Study completion
- May 2001 (actual)
- First posted
- 7 Mar 2008 (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 purpose of this study is to determine which treatment, band ligation (placing rubber bands around the hemorrhoids) or BICAP electrocoagulation (using electricity to cauterize) is safer and more effective endoscopic treatment for bleeding internal hemorrhoids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Rubber band ligationRubber band ligation |
| 2 | Active comparator | Procedure: Bipolar coagulationBipolar coagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Grade II or III internal hemorrhoids with chronic rectal bleeding, which failed at least 8 weeks of intensive medical therapy.
- Age over 18 years
- A life expectancy of at least 24 months
- A signed written informed consent
Key exclusion criteria (14 listed)
- The patient was uncooperative or could not return for routine outpatient follow-up
- Severe or end-stage co-morbid illness
- Prior endoscopic or surgical treatment of hemorrhoids within the past 6 months
- Ongoing need for anticoagulation therapy or high doses of aspirin or non-steroidal antiinflammatory agents
- Presence of severe rectal pain
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 ligationplacing rubber bands around the internal hemorrhoids | Procedure or surgery | 1 |
| Bipolar coagulationusing electricity to cauterize | Procedure or surgery | 2 |
Primary outcome
treatment success rate
Time frame: one year
1 secondary outcome
treatment complication rate
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bipolar coagulation in people with Hemorrhoids, run by University of California, Los Angeles at 1 site in United States.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 7 Mar 2008. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
treatment success 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?
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 7 Mar 2008.