NCT02039570

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

7 months

First QC Date

January 16, 2014

Last Update Submit

January 16, 2014

Conditions

Haemorrhoids

Keywords

haemorrhoidspelvic reflux

Outcome Measures

Primary Outcomes (1)

  • 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 1. trickle reflux 2. significant reflux 3. severe reflux

    Immediatley

Other Outcomes (2)

  • Reflux in internal iliac veins

    immediatley

  • Goligher classification

    immedialtey

Study Arms (1)

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

Interventions

Transvaginal scanOTHER

transvaginal scan conducted using duplex ultrasonography

haemorrhoids

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • male
  • aged younger than 18 or older than 80
  • Those unwilling to attend for a transvaginal scan at The Whiteley Clinic, Guildford

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Whiteley Clinic

Surrey, Guildford, GU2 7RF, United Kingdom

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mark Whiteley, Professor

    The Whiteley Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 17, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

GB(1)