Clinical Trial: The Relationship Between Haemorrhoids and Pelvic Vein Reflux

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Investigating the Relationship Between Haemorrhoids, Internal Iliac Veins and Tributary Reflux

Brief 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.


Detailed Summary:

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 ultra
Sponsor: The Whiteley Clinic

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Whiteley Clinic

Dates:
Date Received: January 16, 2014
Date Started: March 2014
Date Completion: December 2014
Last Updated: January 16, 2014
Last Verified: January 2014