The Relationship Between Haemorrhoids and Pelvic Vein Reflux

Haemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02039570
• Other study ID #: HaemorrhoidsJan2104
• Status: Not yet recruiting
• Phase: N/A
• First received: January 16, 2014
• Last updated: January 16, 2014
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: The Whiteley Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 57
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Haemorrhoids
• Hemorrhoids

Intervention

Other:
• Transvaginal scan
transvaginal scan conducted using duplex ultrasonography

Locations

Country	Name	City	State
United Kingdom	The Whiteley Clinic	Surrey	Guildford

Sponsors (1)

Lead Sponsor	Collaborator
The Whiteley Clinic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reflux in internal iliac veins	internal iliac veins in the left and right legs will be rated using the following scale 0 no reflux; trickle reflux; significant reflux; severe reflux	immediatley	No
Other	Goligher classification	The Goligher classification will be used to rate the severity of the participants' haemorrhoids	immedialtey	No
Primary	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	Immediatley	No