The Relationship Between Haemorrhoids and Pelvic Vein Reflux

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

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.

Study Overview

• Status: Unknown
• Conditions: Haemorrhoids
• Intervention / Treatment: Other: 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.

• Study Type: Observational
• Enrollment (Anticipated): 57

Contacts and Locations

Study Locations

• United Kingdom
  • Guildford
    • Surrey, Guildford, United Kingdom, GU2 7RF
      • The Whiteley Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

the sample will be selected from female patients presenting in primary care with symptomatic haemorrhoids

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Goligher classification	The Goligher classification will be used to rate the severity of the participants' haemorrhoids	immedialtey

Collaborators and Investigators

• Sponsor: The Whiteley Clinic
• Investigators: Principal Investigator: Mark Whiteley, Professor, The Whiteley Clinic

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: January 16, 2014
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimate): January 17, 2014

Study Record Updates

• Last Update Posted (Estimate): January 17, 2014
• Last Update Submitted That Met QC Criteria: January 16, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: haemorrhoids; pelvic reflux
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: HaemorrhoidsJan2104