HaemorrhoidsNCT02039570
The Relationship Between Haemorrhoids and Pelvic Vein Reflux
An observational study of Haemorrhoids, run by The Whiteley Clinic at 1 site in United Kingdom.
Trial summary
This case series aims to find out in a group of female patients suffering from haemorrhoids, how many of them have pelvic vein reflux that feeds into their haemorrhoids. This will be done by examining their ovarian and internal iliac veins for reflux, using a transvaginal scan. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Haemorrhoids
- What is being tested?
- Transvaginal scan
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Dec 2014
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: the sample will be selected from female patients presenting in primary care with symptomatic haemorrhoids
Who may be able to join
- Female
- Symptomatic haemorrhoids
- Being able and willing to undergo transvaginal ultrasound scan to assess their ovarian and internal iliac veins
- Aged between 18 and 80 years
- good understanding of written and spoken english
Who cannot join
- male
- aged younger than 18 or older than 80
- Those unwilling to attend for a transvaginal scan at The Whiteley Clinic, Guildford
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Whiteley Clinic
Surrey, Guildford, GU2 7RF
Briony Hudson, 01483 477180, briony.hudson@hotmail.com
Isabel Kay, 01483 477180, isabel@thewhiteleyclinic.co.uk
About this study
Official title: Investigating the Relationship Between Haemorrhoids, Internal Iliac Veins and Tributary Reflux
This case series aims to find out in a group of female patients suffering from haemorrhoids, how many of them have pelvic vein reflux that feeds into their haemorrhoids.
This will be done by examining their ovarian and internal iliac veins for reflux, using a transvaginal scan.
Read the detailed description
Based on previous research, we believe that haemorrhoids could be caused by faulty valves in the veins running from deep within the pelvic region to the lower part of the abdomen (internal iliac veins)resulting in reflux in the tributaries.
We have already presented research showing that patients with severe pelvic vein reflux, particularly of the internal iliac veins and tributaries, are associated with a higher chance of haemorrhoids.
The aim of this study is to see in a group of patients suffering from haemorrhoids, whether all of them exhibit pelvic vein reflux feeding into the haemorrhoids.
If we are able to prove that either all or the vast majority of patients with true haemorrhoids do have pelvic vein reflux feeding into them, this will support our hypothesis that the internal iliac vein and tributary reflux is causative of haemorrhoids.
following this, in a future study we will treat internal iliac vein and tributary reflux to see if the results of haemorrhoid treatments are improved.
If we find only a few patients with haemorrhoids have associated internal iliac vein and tributary reflux feeding into the haemorrhoids, we will be able to refute the hypothesis that there is a causative association, and will not need to progress with the studies and will look instead for a different aetiology.
At the current time, there is no effective way of investigating male pelvic vein reflux. The gold standard investigation for pelvic vein reflux is transvaginal duplex ultrasound scan. As such this study will be restricted to females presenting with symptomatically haemorrhoids who are able and willing to undergo transvaginal ultrasound scan to assess their pelvic veins.
- Conditions
- Haemorrhoids
- Being tested
- Transvaginal scan
- Keywords
- haemorrhoids, pelvic reflux
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal scanOther
transvaginal scan conducted using duplex ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| haemorrhoids | The cohort contains only patients with symptomatic haemorrhoids - these patients will receive a transvaginal scan to examine their ovarian and internal iliac veins to ascertain whether there is any reflux Receives: Other: Transvaginal scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux in ovarian veins
Following a transvaginal scan pelvic reflux in both the right and left leg separately will be rated on a four point scale 0 no reflux
- trickle reflux
- significant reflux
- severe reflux
Measured: Immediatley
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemorrhoidsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Whiteley Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Whiteley, Professor, Principal investigator, The Whiteley Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039570
- Sponsor's protocol ID
- HaemorrhoidsJan2104
- Status last verified
- Jan 2014
- First submitted
- 16 Jan 2014
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between Haemorrhoids, Internal Iliac Veins and Tributary Reflux
- ClinicalTrials.gov ID
- NCT02039570
- Acronym / sponsor ID
- HaemorrhoidsJan2104
- Conditions
- Haemorrhoids
- Keywords
- haemorrhoids, pelvic reflux
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- The Whiteley ClinicUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 17 Jan 2014 (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.
This case series aims to find out in a group of female patients suffering from haemorrhoids, how many of them have pelvic vein reflux that feeds into their haemorrhoids.
This will be done by examining their ovarian and internal iliac veins for reflux, using a transvaginal scan.
Detailed description
Based on previous research, we believe that haemorrhoids could be caused by faulty valves in the veins running from deep within the pelvic region to the lower part of the abdomen (internal iliac veins)resulting in reflux in the tributaries.
We have already presented research showing that patients with severe pelvic vein reflux, particularly of the internal iliac veins and tributaries, are associated with a higher chance of haemorrhoids.
The aim of this study is to see in a group of patients suffering from haemorrhoids, whether all of them exhibit pelvic vein reflux feeding into the haemorrhoids.
If we are able to prove that either all or the vast majority of patients with true haemorrhoids do have pelvic vein reflux feeding into them, this will support our hypothesis that the internal iliac vein and tributary reflux is causative of haemorrhoids.
following this, in a future study we will treat internal iliac vein and tributary reflux to see if the results of haemorrhoid treatments are improved.
If we find only a few patients with haemorrhoids have associated internal iliac vein and tributary reflux feeding into the haemorrhoids, we will be able to refute the hypothesis that there is a causative association, and will not need to progress with the studies and will look instead for a different aetiology.
At the current time, there is no effective way of investigating male pelvic vein reflux. The gold standard investigation for pelvic vein reflux is transvaginal duplex ultrasound scan. As such this study will be restricted to females presenting with symptomatically haemorrhoids who are able and willing to undergo transvaginal ultrasound scan to assess their pelvic veins.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| haemorrhoids | – | Other: Transvaginal scanThe cohort contains only patients with symptomatic haemorrhoids - these patients will receive a transvaginal scan to examine their ovarian and internal iliac veins to ascertain whether there is any reflux |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the sample will be selected from female patients presenting in primary care with symptomatic haemorrhoids
Key inclusion criteria (5 listed)
- Female
- Symptomatic haemorrhoids
- Being able and willing to undergo transvaginal ultrasound scan to assess their ovarian and internal iliac veins
- Aged between 18 and 80 years
- good understanding of written and spoken english
Key exclusion criteria (3 listed)
- male
- aged younger than 18 or older than 80
- Those unwilling to attend for a transvaginal scan at The Whiteley Clinic, Guildford
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 |
|---|---|---|
| Transvaginal scantransvaginal scan conducted using duplex ultrasonography | Other | haemorrhoids |
Primary outcome
Reflux in ovarian veins
Time frame: Immediatley
Following a transvaginal scan pelvic reflux in both the right and left leg separately will be rated on a four point scale 0 no reflux 1. trickle reflux 2. significant reflux 3. severe reflux
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
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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.
Mark Whiteley, Professor principal investigator
The Whiteley Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemorrhoids, run by The Whiteley Clinic at 1 site in United Kingdom.
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 5 inclusion and 3 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 17 Jan 2014. 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 Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux in ovarian veins (time frame: Immediatley). 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 17 Jan 2014.