The Relationship Between Haemorrhoids and Pelvic Vein Reflux

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by The Whiteley Clinic
Sponsor:
Information provided by (Responsible Party):
The Whiteley Clinic
ClinicalTrials.gov Identifier:
NCT02039570
First received: January 16, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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
Haemorrhoids
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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039570

Locations
United Kingdom
The Whiteley Clinic Not yet recruiting
Surrey, Guildford, United Kingdom, GU2 7RF
Contact: Briony Hudson    01483 477180    briony.hudson@hotmail.com   
Contact: Isabel Kay    01483 477180    isabel@thewhiteleyclinic.co.uk   
Principal Investigator: Mark Whiteley, Professor         
Sub-Investigator: Judy Holdstock         
Sub-Investigator: Charmaine Harrison         
Sub-Investigator: Briony Hudson         
Sponsors and Collaborators
The Whiteley Clinic
Investigators
Principal Investigator: Mark Whiteley, Professor The Whiteley Clinic
  More Information

No publications provided

Responsible Party: The Whiteley Clinic
ClinicalTrials.gov Identifier: NCT02039570     History of Changes
Other Study ID Numbers: HaemorrhoidsJan2104
Study First Received: January 16, 2014
Last Updated: January 16, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by The Whiteley Clinic:
haemorrhoids
pelvic reflux

Additional relevant MeSH terms:
Hemorrhoids
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014