Clinical trial NCT02039570: The Relationship Between Haemorrhoids and Pelvic Vein Reflux
Official title: Investigating the Relationship Between Haemorrhoids, Internal Iliac Veins and Tributary Reflux
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Haemorrhoids
Keywords: haemorrhoids
pelvic reflux
Lead sponsor: The Whiteley Clinic
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the sample will be selected from female patients presenting in primary care with symptomatic haemorrhoids

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 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 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

Primary outcomes:
measure: Reflux in ovarian veins
timeFrame: Immediatley
Secondary outcomes:
Other outcomes:
measure: Reflux in internal iliac veins
timeFrame: immediatley
measure: Goligher classification
timeFrame: immedialtey
Locations:
city: Surrey
country: United Kingdom
facility: The Whiteley Clinic
state: Guildford
Study officials:
affiliation: The Whiteley Clinic
name: Mark Whiteley, Professor
role: PRINCIPAL_INVESTIGATOR
References: