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The Relationship Between Haemorrhoids and Pelvic Vein Reflux

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by The Whiteley Clinic.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
The Whiteley Clinic Identifier:
First received: January 16, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

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.

Condition Intervention
Other: Transvaginal scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigating the Relationship Between Haemorrhoids, Internal Iliac Veins and Tributary Reflux

Resource links provided by NLM:

Further study details as provided by The Whiteley Clinic:

Primary Outcome Measures:
  • 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

Other Outcome Measures:
  • Reflux in internal iliac veins [ Time Frame: immediatley ]

    internal iliac veins in the left and right legs will be rated using the following scale 0 no reflux

    1. trickle reflux
    2. significant reflux
    3. severe reflux

  • Goligher classification [ Time Frame: immedialtey ]
    The Goligher classification will be used to rate the severity of the participants' haemorrhoids

Estimated Enrollment: 57
Study Start Date: March 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other: Transvaginal scan
transvaginal scan conducted using duplex ultrasonography

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
the sample will be selected from female patients presenting in primary care with symptomatic haemorrhoids

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • male
  • aged younger than 18 or older than 80
  • Those unwilling to attend for a transvaginal scan at The Whiteley Clinic, Guildford
  Contacts and Locations
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Please refer to this study by its identifier: NCT02039570

United Kingdom
The Whiteley Clinic Not yet recruiting
Surrey, Guildford, United Kingdom, GU2 7RF
Contact: Briony Hudson    01483 477180   
Contact: Isabel Kay    01483 477180   
Principal Investigator: Mark Whiteley, Professor         
Sub-Investigator: Judy Holdstock         
Sub-Investigator: Charmaine Harrison         
Sub-Investigator: Briony Hudson         
Sponsors and Collaborators
The Whiteley Clinic
Principal Investigator: Mark Whiteley, Professor The Whiteley Clinic
  More Information

Responsible Party: The Whiteley Clinic Identifier: NCT02039570     History of Changes
Other Study ID Numbers: HaemorrhoidsJan2104
Study First Received: January 16, 2014
Last Updated: January 16, 2014

Keywords provided by The Whiteley Clinic:
pelvic reflux

Additional relevant MeSH terms:
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on April 26, 2017